MMDA and Post Traumatic Stress Disorder

It is not surprising that this substance could be used for good in cases like PTSD, a condition in which the very soul of a person seems to be injured.

R&D Medicines > MDMA

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MAPS’ top priority project is funding clinical trials of methylenedioxymethamphetamine (MDMA) as a therapeutic tool to assist psychotherapy for the treatment of Posttraumatic Stress Disorder (PTSD) and other illnesses. Preliminary studies have shown that MDMA in conjunction with psychotherapy can help people overcome PTSD.  MDMA has empathogenic effects, and it is also known as the popular drug Ecstasy (although "Ecstasy" does not always contain pure MDMA). In laboratory studies, MDMA has been proven sufficiently safe for human consumption when taken a limited number of times in moderate doses. MAPS is in the midst of a 10 year - $10 million plan to make MDMA into a government-approved prescription medicine. For-profit pharmaceutical companies are not interested in developing MDMA into a medicine, because the patent for MDMA has expired. Companies cannot profit off of MDMA because it is only administered a limited number of times, unlike most medications for mental illnesses that are taken on a daily basis. Consequently MAPS is the only organization funding clinical trials of MDMA-assisted psychotherapy in the world. MAPS is studying whether MDMA-assisted psychotherapy has the potential to heal traumas caused by sexual assault, war, violent crime, and other causes. Below is comprehensive and updated information about MAPS efforts to develop MDMA into a government-approved prescription medicine, as well as useful information for understanding the benefits and risks of MDMA use.

MDMA Breaking News MDMA News Timeline February 19, 2010. MAPS. "Overview of amphetamine-type stimulant deaths in the UK - critical review and commentary." By Ilsa Jerome, Ph.D. Despite news generated by a new study authored by Schifano and colleagues, ecstasy is not especially deadly in younger people. January 15, 2010. MAPS MDMA Supply Analyzed for Quality MAPS currently owns approximately 17 grams of MDMA. We are having the supply of MDMA reexamined for quality assurance. The analysis is intended to make sure that the MDMA has not degraded over time. We will be dividing the 17 grams among several new studies that we are starting. We will have to order new MDMA in the near future for future studies. January 14, 2010. Canadian Study Still on Hold, Waiting for Institutional Affiliation Our MDMA/PTSD study in Canada is still on hold as we seek affiliation with an institution. Unlike our U.S. Study, which was conducted in the private offices of our principal investigator, Health Canada is requiring that our research be conducted at an institution. This has been a large disappointment for us, and an unforeseen hurdle. We had been under the impression for months that the only remaining item to take care of in order to start the study was obtaining a license to import MDMA from our supplier in Switzerland. January 11, 2010. Jordanian Insurance Agency Paid $6,800 to Insure MDMA Study We have paid $6,800 to a Jordanian insurance agency in order to insure our planned MDMA/PTSD study in Jordan. All of the documents for the Jordanian study can be found on this MDMA webpage in the "MDMA/PTSD Jordan Study" section. January 8, 2010. Last MDMA Session in Switzerland MDMA/PTSD Study The final session in our Swiss MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) took place on Friday, January 8, 2010. The twelfth and final subject received MDMA in the stage two open label portion of the trial, which means that he had previously received a placebo dose. Two months from this last session will be the final data gathering point in this study. One year from now will be the final date point in the long-term follow of this research. We are pleased to report that just like our U.S. pilot study there was an excellent safety record.  There is no evidence of any harm caused to any of the subjects by administering research grade MDMA in a therapeutic setting. Preliminary data analysis suggests that the research will have statistically significant results in reduction of PTSD symptoms in the subject population. January 6, 2010. MAPS Plans New MDMA/PTSD Study in Spain MAPS colleague Jose Carlos Bouso, Ph.D. Candidate, previous principal investigator of an MDMA/PTSD study in Spain, did not receive a 200,000 Euro government grant he had applied for last year. Jose had hoped to utilize the government grant to conduct a new study of MDMA-assisted psychotherapy for the treatment of PTSD. In light of the absence of the grant, MAPS Executive Director Rick Doblin, Ph.D. had met with MAPS clinical research team to conceptualize sponsoring and designing a study in Spain for Jose to lead. The basic concept is that MAPS will fund the study for two subjects and then evaluate whether the research team is properly adhering with the protocol, data-gathering, and therapeutic method before funding additional participants. This concept is to insure that we spend our donated research funds on successful, well-managed projects. December 30, 2009. MDMA Therapist Training Protocol Approved by IRB (Psychological Effects of MDMA in Healthy Volunteers) Our Institutional Review Board (IRB) has approved our protocol designed as a Phase 1 study of the psychological effects of MDMA in healthy volunteers. To view all of the documents that have entailed the approval process on this webpage look in the "MDMA/PTSD Training Protocol for Researchers/Phase 1 Psychological Effects Study" section. December 23, 2009. MDMA/PTSD Veteran of War Protocol Submitted to FDA We have submitted the protocol (part 1, part 2, part 3) for our planned study of MDMA-assisted psychotherapy for the treatment of veterans of war with chronic posttraumatic stress disorder (PTSD) to the FDA. All of the documents that were submitted can be found on this "MDMA webpage in the MDMA/PTSD U.S. Study (Veterans of War)" section. December 21, 2009.  Preliminary Documents for Jordanian MDMA/PTSD Study Submitted for Review to Clinical Research Organization Several templates for our planned study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) have been submitted for review to Clinquest JO, a Jordanian Clinical Research Organization. These documents include, the protocol, the protocol synopsis, the case report forms (CRF), and the principal investigators CV. All of the documents for the Jordanian study can be found on this MDMA webpage in the "MDMA/PTSD Jordan Study" section. December 5, 2009. MDMA-Therapist Training Protocol Resubmitted to IRB After our first therapist training protocol (cleared by the FDA as a Phase 1 study of MDMAs psychological effects on healthy subjects) was initially deferred by the institutional review board (IRB), we resubmitted the protocol to the IRB and addressed the IRBs concerns. The resubmission includes a cover letter, a deferral response, an amended informed consent form, and an amended protocol. The submission was accompanied by letters of support from University of West Georgia Psychology Professor Daniel A. Helminiak, Ph.D., and Johns Hopkins researcher William Richards, Ph.D. and a joint letter from Johns Hopkins research team Mathew Johnson, Ph.D., William Richards, Ph.D., and Roland Griffiths, Ph.D. December 4, 2009. Next version MDMA/PTSD Treatment Manual to be edited by Sherry Falsetti, Ph.D. We are very pleased to have contracted Psychologist Sherry Falsetti, Ph.D. to edit MAPS MDMA/PTSD treatment manual and to create instruments to measure a therapists compliance with the manuals techniques. An important part of the MDMA-assisted psychotherapy drug development process is to assess whether therapists are administering the therapy in a uniform manner consistent with the treatment manual. Sherry brings to the position years of experience from the field of psychology and medicine working with PTSD. She has prior experience developing treatment manuals and creating compliance measures. December 3, 2009. Spanish MDMA Team Denied Grant New Ideas Underway for MAPS Research in European Union Unfortunately, a several hundred thousand euro grant that MAPS colleague and Spanish Researcher Jose Carlos Bouso, Ph.D. Candidate applied for to conduct an MDMA/PTSD study in Spain was rejected. MAPS will now pursue other avenues to conduct additional MDMA/PTSD research within the European Union. One of the ideas that we plan to implement will be to have future studies use an open label dosing regimen for the first two subjects. This means that the first two subjects in a study will receive MDMA, rather than MDMA or placebo. MAPS will use this as a chance to monitor the research teams adherence to the protocol guidelines. December 1, 2009. Jordanian MDMA/PTSD Study Selects Insurance Provider -- Protocol is Able to be Submitted to IRB Our study in Jordan is able to move another step forward now that we have reached an agreement with a Jordanian insurance agency. Now that the study is insured we can submit the protocol to the Jordanian institutional review board (IRB). We have also reached an agreement with Principal Investigator Nasser Shuriquie, M.D. that the subjects enrolled in the study will be treatment resistant. This means that subjects will have to have previously attempted talk and drug therapy to treat their PTSD without success. November 10, 2009. Health Canada Places Major Hurdle in Front of MDMA/PTSD Study After over a year of planning and preparations to conduct an MDMA/PTSD study in Vancouver, Health Canada placed a major hurdle on the study. For the past several months, we have been under the impression that obtaining a permit to import the MDMA to Canada was the only thing standing in the way of starting the study. Unfortunately we have now been told that our study needs to be conducted in conjunction with a Canadian institution, and will likely have to take place at that institution. We had previously planned for the study to take place at the private office of Principal Investigator Ingrid Pacey, M.D. We are now working to figure out the best means of affiliating Ingrid with an institution and what impact this will have on our projected budget for this study. October 25, 2009. MAPS Starts Sister Organization in Canada MAPS Canada! MAPS has partnered with a few Canadian Citizens to create MAPS Canada an official Canadian non-profit and sister organization to MAPS. MAPS Canada is being created to allow Canadian Citizens to make tax-deductible donations directly to MAPS-related projects (currently MAPS has a partnership with Tides Canada for Canadian Citizens to make donations to MAPS, call our office for details). MAPS Canada will provide the thriving  Canadian psychedelic community an outlet to fund more psychedelic research projects in Canada. The Board of Directors is likely to consist of Rick Doblin, Ph.D., Valerie Mojeiko, B.A., and Robert Barnhart of the United States and Mark Haden and Phillipe Lucas from Canada. We are approaching other Canadians to join the Board so Canadians will compose the majority of the Board. The legal documentation is underway for this project. October 24, 2009. Canadians Welcome MDMA/PTSD Study in Vancouver We had an exciting fundraiser in Vancouver, British Colombia, Canada, where we raised over $10,000 for our planned Canadian MDMA/PTSD study. The benefit dinner was attended by several prominent figures in the Canadian drug policy reform movement, including former Vancouver Mayor Philip Owen, architect of Vancouvers four-pillar drug strategy Donald MacPherson, Vancouver Island City Council Member Phillipe Lucas, Drug Policy and Health Expert Mark Haden, and numerous others. MAPS is grateful to all those who attended and offered financial support! Also while in Vancouver, MAPS Deputy Director Valerie Mojeiko conducted a second pre-study visit with Principal Investigators Ingrid Pacey, M.D. and Andrew Feldmar, M.A., and study assistant Amanda Walker. October 11, 2009.  Progress Report: Jordan and Israel MDMA/PTSD Research On September 30, we submitted our draft protocol, informed consent, and Case Report Forms for our Jordanian MDMA/PTSD research to Principal Investigator Nasser Shuriquie, M.D. and his Jordanian research team, and to Clinquest JO, a Jordanian Contract Research Organization (CRO). We have decided to hire Clinquest JO to monitor the study in order to limit the amount of travel and resources that our U.S. monitoring team would have to expend to travel frequently to Jordan. Furthermore, Clinquest JO helped to establish the Jordanian FDA, are culturally situated to Jordan, and speak Arabic. We are impressed with their quality of work and will be pleased to work with them. Dr. Shuriquie introduced Kamila Novak, Ph.D. of Clinquest JO to MAPS Executive Director Rick Doblin Ph.D. when Rick was in Jordan on August 13, 2009. On October 20, Rick and Michael Mithoefer, M.D. will go to Amman, Jordan to make a presentation about the research agenda to representatives of the Jordanian FDA, Dr. Shuriquie, Shuriquies co-therapist and others who may be involved in the study. Clinquest JO will bring several clinical research staff from Egypt to hear the presentation. MAPS is excited to be venturing through the doorway to the Arabic research world. From October 18-23, Michael and Rick will attend the conference "Future Directions in PTSD: Prevention, Diagnosis and Treatment," put on by the Institute for Advanced Studies at the Hebrew University of Jerusalem. Michael will present a poster on MAPS MDMA/PTSD pilot study at the conference. Michael and Rick will also meet with Efrat Yasur, founder of Transcom Global, an Israeli CRO. MAPS is hiring Transcom Global to monitor our Israeli MDMA/PTSD study. October 9, 2009.  Several MDMA/PTSD Protocol Documents Revised In light of the results from our US MDMA/PTSD pilot study and preliminary results from our Swiss and Israeli pilot studies, we have completed an overall review of our methodology and study documents used in our studies. We have incorporated what we have learned in revised versions of our MDMA/PTSD protocols and Case Report Forms (CRFs). The revised protocols are designed to be more efficient. We have narrowed down our research focus and have eliminated some redundant outcome measures from the protocols. Weve also added a measure of suicidality required by the FDA for all studies using drugs that have psychological effects. One of the strengths of MAPS drug development approach is our willingness to do the extra work required to incorporate lessons learned in our protocols as they are in process. This fine-tuning is the essence of what Phase 2 pilot studies are all about. They are learning opportunities for the development and design of Phase 3 multi-site studies. The Phase 3 studies will evaluate in a large number of subjects the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. The outcome of these Phase 3 studies will determine if the FDA and other regulatory agencies eventually approve MDMA for prescription use. October 8, 2009. MAPS Next U.S. MDMA/PTSD Study in Veterans Protocol Development Proceeds Were close to completing the protocol design for our upcoming U.S. MDMA/PTSD study exclusively for veterans of war. We plan to submit this protocol to the FDA in November 2009. A crucial protocol design meeting with Rick Doblin, Ph.D., Michael Mithoefer, M.D. and Ilsa Jerome, Ph.D. took place several weeks ago at Ricks home office. We will be using the Phase 2 study in veterans to test a possible design for our Phase 3 multi-site studies -- our most sophisticated protocol design to date. We will provide more information about details of the protocol in an upcoming email newsletter. October 2, 2009. Clinical Psychology Review. "Emerging treatments for PTSD." By Judith Cukor, Josh Spitalnick, JoAnn Difede, Albert Rizzo, and Barbara O. Rothbaum This scientific, peer-reviewed paper has a section on MDMA. The authors quote an article from Rick Doblin, Ph.D. published in 2002 which was about MAPS' MDMA/PTSD Clinical Plan. They also quote Andy Parrott about MDMA's therapeutic potential, even though he has mostly written about the risks of MDMA. September 30, 2009. Rick Doblin was interviewed on CFAX-1070 AM, a Canadian news radio station about MAPS MDMA/PTSD research in Vancouver. Several listeners called into ask Rick questions. This can be listened to as an mp3 or wav file. September 16, 2009.  Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA The FDA permitted us to proceed with our clinical investigation, "A Phase I Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA when Administered to Healthy Volunteers," also referred to as our MDMA/PTSD therapist training protocol. Through extensive discussions and cooperation with the FDA, the protocol meets two goals at once. On the one hand, it is designed as a Phase 1 randomized, placebo-controlled, double-blind study of the psychological effects of MDMA on healthy volunteers. On the other hand, enrollment is limited to subjects who are participating in our MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) therapist training program. The final draft of the protocol meets both the FDAs goals and MAPS goals. Now that we have the FDAs "may proceed" letter, we will be seeking approval from an Institutional Review Board (IRB). We will be measuring the psychological effects of MDMA on "healthy normals" as contrasted with our international series of Phase 2 pilot studies evaluating MDMA-assisted psychotherapy in people who have treatment-resistant posttraumatic stress disorder (PTSD). We will employ some psychological measures that have not yet been used in an MDMA research project as well as some that we have used before. The psychological measures include measuring mood with the Profile of Mood States, personality with the Neuroticism-Extroversion-Openness (NEO) Inventory, interpersonal closeness with a nonverbal (visual analog) self-report measure, psychological symptoms with the Brief Symptom Inventory (BSI), and suicidality with the Columbia Suicide Severity Rating Scale (C-SSRS). As a crossover study, subjects will get placebo on one occasion and MDMA on the other. The FDAs "may proceed letter marks a major turning point for MAPS. We now have the ability to offer one full-dose MDMA-assisted psychotherapy session to therapists who are preparing to conduct Phase 2 and Phase 3 MDMA/PTSD studies for MAPS. During these studies we will be gathering information about the psychological dynamics of MDMA-assisted psychotherapy. We believe that this new protocol substantially increases the chances that we will successfully conduct the next step in our mission: a Phase 3 multi-site pilot study with 20-30 co-therapist teams. September 15, 2009. US MDMA/PTSD Pilot Study Manuscript Rejected by Journal We learned a few weeks ago that the Archives of General Psychiatry rejected our manuscript about MAPS flagship U.S. MDMA/PTSD pilot study. While we are very disappointed that the paper was rejected, we knew that it would be a long shot since this is the leading journal in the field of psychiatry and it has a conservative reputation. While some of the reviewers comments were quite insightful, other comments about MDMAs safety and the study design were simply mistaken. We are in the process of taking the insightful comments into consideration and rewriting the paper for submission to a new journal. September 14, 2009. Canadian MDMA/PTSD study: Application to Import MDMA Submitted We are in the final stages of getting our Canadian MDMA/PTSD study up and running. At the beginning of this month, Colin Holyk from Kerrisdale Pharmacy went to the Royal Canadian Mounted Police (RCMP) to be fingerprinted and have a criminal records background check as part of the process to become licensed to import MDMA into Canada. He has now applied to Health Canada for the license. We do not know how long it will take Health Canada to process his application, but we hope it will not be more than a month. After the pharmacist receives his license to import, we will obtain a specific import and export permit to have the roughly 7 grams of MDMA shipped to Vancouver from Switzerland. MAPS clinical research team is currently preparing documents for a pre-initiation site visit to take place on Thursday October 22. September 2, 2009.  MDMA/PTSD Research Reported in Canadian Globe and Mail The popular British Columbian Globe and Mail newspaper ran an article about MAPS planned MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) study, to take place in Vancouver, BC. The article titled, "Landmark B.C. study lets trauma suffers find relief with ecstasy" was written by Frances Bula, who presented a concise overview of the study to Canadian readers. As a result of this article, Ingrid Pacey, M.D. the Principal Investigator of the study, received a deluge of media inquiries and even discussed the study on Canadian National TV. August 24, 2009. MAPS Executive Director Rick Doblin Meets with Israeli MDMA/PTSD Team On August 12, 2009, MAPS Executive Director Rick Doblin, Ph.D. met with Moshe Kotler, M.D., Principal Investigator of our Israeli MDMA/PTSD study. The two of them discussed the progress of the study and other administrative matters. On August 24, Rick met with lead psychiatrist Sergio Marchevsky, M.D., and co-therapist Tali Nachoni, M.D. of the MAPS-sponsored Israeli MDMA/PTSD research team. They discussed the status of the fourth subject being treated in the study. Sergio reported to Rick that he felt more comfortable conducting MDMA-assisted psychotherapy after the therapist training seminar that took place in Austria this past June. Rick and Sergio further discussed plans to accelerate enrollment of subjects into the study, which is designed for 12 subjects. While meeting with Sergio, Rick noticed a poster on the wall announcing an international scientific conference on PTSD to take place in Jerusalem in late October. Rick and MAPS lead researcher Michael Mithoefer, M.D., are now planning to attend that conference, at which Michael will present a poster about the results of our US MDMA/PTSD study. August 13, 2009. New Hospital Found for Jordanian MDMA/PTSD Study MAPS Executive Director Rick Doblin Ph.D. visited Amman, Jordan to further explore MAPS planned Jordanian MDMA/PTSD study. Principal Investigator Dr. Nasser Shuriquie, who had been working for the Royal Jordanian Medical Services at the Jordanian Military Hospital in Amman, has taken a new position as the medical director of Al-Rashid Hospital, the first and largest psychiatric hospital in Jordan. Rick visited with Nasser at Al-Rashid and met with the hospital administrator Dr. Rifat Dadawi Al-Masri. After discussions and a tour of the facilities, Rick concluded that Al-Rashid Hospital would be an excellent place to conduct our study. While in Jordan, Rick was introduced by Nasser to representatives of Clinquest JO, a clinical research organization that assists pharmaceutical companies with conducting clinical studies in accordance with Jordanian and international standards of clinical research. The representatives are General Manager Maha Tutunji, M.D. and Managing Director Kamilla Novak, M.D. It is likely that MAPS will hire Clinquest to conduct data and study monitoring and manage Jordanian regulatory affairs. This will make conducting the study in Jordan more economical and convenient. The next steps for the Jordanian study are to finalize the protocol design elements for budgeting and submission to regulatory authorities in Jordan. MAPS lead researcher Michael Mithoefer M.D. and Rick are planning a visit to Jordan on October 20, to speak to Nasser and associates about the results of our US study and our treatment method. This visit is timed so Michael and Rick can also attend an international scientific conference on PTSD taking place in Israel. August 12, 2009.  Second Productive Teleconference with the U.S. FDA about MDMA Therapist Training Protocol MAPS Researchers Michael Mithoefer, M.D., Ilsa Jerome, Ph.D., Amy Emerson, Valerie Mojeiko, and Rick Doblin Ph.D. had a second teleconference about our MDMA-therapist training protocol with officials in the FDAs Division of Psychiatric Products. The FDA requested that we add additional psychiatric measures for pre-and post-MDMA administration and that we design the study with a double-blind, placebo-controlled methodology. The alterations to the protocol will more rigorously examine the psychological effects of MDMA on healthy volunteers. We will be permitted to limit subjects to the therapists in our training program who will conduct Phase 2 and Phase 3 MDMA/PTSD studies. Our research team is in the process of modifying the protocol according to the FDAs requests and will be submitting a new version within the next week. We expect to obtain approval from FDA upon our next submission and will then submit the protocol to our Institutional Review Board. August 10, 2009. Matt Palmquist, writer for Miller-Mccune, published an article titled, The Ecstasy and the Agony, featuring interviews with Norwegian scientists Pl-rjan Johansen and Teri Krebs. Krebs and Johansen discuss their paper, "How could MDMA help anxiety disorders? A neurobiological rationale," published in the Journal of Pharmacology. June 22, 2009. Therapist Training Protocol Submitted to FDA We submitted to FDA a protocol that would allow therapist from our MDMA/PTSD research teams to take MDMA in a clinical-therapeutic setting. We believe that it will benefit therapist who will be working with patients undergoing difficult emotional therapy to have a subjective understanding of an MDMA experience. The only way such an experience can be legally obtained is through FDA approval of a protocol for that purpose. There is a precedent for our current protocol from the 1970s. Dr. Stanislav Grofs team at Spring Grove Hospital had FDA permission to administer LSD to mental health professionals involved in LSD research. Over 100 medical professionals received LSD in those training sessions, including doctors, therapists, counselors, nurses and attendants. These LSD sessions helped the mental health workers apply a therapeutic approach to patients undergoing LSD psychotherapy and when consulting with patients who had had LSD experiences. We submitted letters from two participants of that program to FDA, including one from John Hopkins researcher William Richards, PhD. Protocol: MDMA Administration in a Therapeutic Setting in People Who Have Completed the MAPS Training Program for Therapists Learning to Conduct MDMA-Assisted Psychotherapy Research in Subjects with PTSD May 13, 2009. MDMA/PTSD Paper Completed and Sent for Friendly Review MAPS is pleased to share that after months of work, our research team has completed a scientific paper that reports the remarkable results from our US MDMA/PTSD pilot study. Dr Michael Mithoefer, Annie Mithoefer, BSN, Ilsa Jerome, PhD, Mark Wagner, PhD, and MAPS President Rick Doblin, PhD, with assistance from statistician Yvonne Michel PhD, spent tremendous effort preparing the paper for submission to a peer-reviewed journal. We have now sent out the paper to several friendly reviewers for informal critique. We will incorporate the feedback we get from these reviewers and then submit the paper to a peer-reviewed scientific journal. This is a major milestone for MAPS and the legitimacy of psychedelic psychotherapy. When the paper is published in a peer-reviewed journal, MDMA-assisted psychotherapy will gain credibility among the scientific community and subsequently the general population. We have not yet released the paper to our readership, but keep checking back on our monthly email update to read about the results of this historic study.   MDMA Data Analysis Nearly Ready for FDA Submission On May 29, 2009, we will submit a preliminary dataset to FDA containing basic safety information from our US MDMA-assisted psychotherapy pilot study. Over the past several months MAPS Clinical Research Associate Valerie Mojeiko has been working diligently with a team of consultants from the pharmaceutical industry to prepare this preliminary data set, and to develop a streamlined collection of standard operating procedures to use in future data sets. This submission to FDA is the first of several data reports from our first pilot study and will provide the scientific justification for future protocols that we will submit to FDA.   Canadian Study Awaits MDMA Import License IRB Services, the Canadian IRB that we are working with, has approved the changes to our MDMA/PTSD protocol that were made by Health Canada. MAPS Canadian MDMA-assisted psychotherapy PTSD study is now at the stage of seeking to import the research-grade MDMA into Canada. MDMA has never been legally imported to Canada before, so the process is a little slow. MAPS is working with a pharmacist who has applied for the license to import and we hope the approval will take place swiftly but we have no idea how long this process will actually take. When the license to import has been obtained, we can go forward with obtaining the specific import/export permits to ship the MDMA from the manufacturer in Switzerland to the pharmacist in Canada. Once the MDMA arrives in Canada, we can start enrolling subjects. On Friday May 8, Valerie Mojeiko and Josh Sonstroem of MAPS Clinical Research Team, went to Vancouver to conduct a pre-study site visit. They met with co-therapists Ingrid Pacey, MD and Andrew Feldmar, PhD along with other site staff. This visit was necessary to ensure that data will be collected in manners compliant with FDA and Health Canada guidelines and that procedures will follow the protocol and IRB rules. We are seeking a research assistant to help with this study 10-20 hours per week who lives in Vancouver and has prior research experience. Please view our job posting for more information. April 16, 2009. MAPS-Sponsored MDMA/PTSD Co-Therapists will Travel to MAPS Training Seminar in Austria, June 25 July 1, 2009: MAPS has finalized plans and chosen a time and location for our first five-day MDMA/PTSD therapist training retreat for MAPS-sponsored researchers. The event will take place at the end of June in the Austrian mountains, where its off-season, reasonably priced, and more-or-less centrally located for therapist teams and MAPS staff coming together from the US, Canada, Switzerland, Spain, Israel, and Jordan. Michael Mithoefer, MD and Annie Mithoefer, BSN, the co-therapist team from MAPS successfully completed U.S. MDMA/PTSD pilot study, will share techniques and results with the other therapists. June May Ruse, PhD, will present the principles in our treatment manual, which she is developing with feedback from our research teams. The therapeutic outcomes in our US study were remarkable. In order to increase the chances that other co-therapist teams can replicate these results in MAPS other studies, Michael and Annie will present videotapes of their sessions and lead discussions about lessons theyve learned. The Swiss and Israeli co-therapist teams, who have treated some subjects but havent completed their studies yet, will also lead presentations about their results and methods. We will also discuss cultural differences, research methodology, and other treatments for PTSD and their similarities and differences from MDMA-assisted psychotherapy. We will have time for a breathwork session and opportunities for informal sharing. MAPS staff will be creating podcasts and writing blogs from the training seminar to keep our members and other interested parties informed of the valuable information that comes from it. This private retreat will also serve to inform MAPS 2010 conference, which is open to medical professionals, MAPS members and the general public. If you are interested in learning more about MDMA/PTSD therapy, please write to Valerie@maps.org and she will put you on a list to receive information about future training opportunities. This therapist training program, the first of its kind, will cost about $20,000. Were currently looking for one or more donors willing to underwrite this historic gathering.   Research Monitoring Team Completes Visits Around the World: Over the past several weeks, MAPS clinical research team members Valerie Mojeiko, Director of Operations and Clinical Research Associate, and Joshua Sonstroem, Information and Technology Specialist and Accountant, visited MAPS research sites around the globe. Visits such as these are conducted periodically to ensure that each research team is conducting their research in accordance with US Food and Drug Administration (FDA) guidelines so that the data can ultimately be presented to the FDA as well as to national regulatory agencies and the European Medicines Agency (EMEA). Valerie and Josh made visits to our Swiss LSD/end-of-life anxiety study and Swiss MDMA/PTSD study. Rick Doblin, PhD joined Valerie and Josh at our Israeli MDMA/PTSD study, and at our proposed Jordanian MDMA/PTSD Study. The Israeli study is budgeted at $90,000, $60,000 remains to be raised.   Canadian MDMA/PTSD Study Gets Green Light from Health Canada: On March 17, Health Canada issued a No Objection Letter for MAPS’ Canadian MDMA/PTSD study. This means that the Canadian protocol and the MDMA that will be used in that study (from Switzerland) have been completely approved by Health Canada. On April 2, Dr. Ingrid Pacey applied for her Section 56 exemption, equivalent to a DEA Schedule 1 license. This license will permit her to possess and handle MDMA for the study. Once she has obtained her Section 56 Exemption, probably within the next month, MAPS can proceed to acquire the necessary import/export permits for shipment of the MDMA from Switzerland to Canada. MAPS monitoring team has scheduled their first pre-study visit to discuss logistics with the team on May 9. If all goes smoothly, we anticipate starting the study within the next 2-3 months. This study is budgeted at $250,000, all of which remains to be raised. April 13, 2009. Harvard MDMA-Cancer/Anxiety Study Update: A study that originated with MAPS, but that is now funded and managed independent of MAPS has had several important updates. The project offers MDMA-assisted psychotherapy and non-drug psychotherapy for advanced-stage cancer patients who are experiencing anxiety and other end-of-life issues not adequately treated by traditional means. The study had only been able to recruit from patients of the oncology service at the Lahey Clinic of Burlington, MA. Study candidates now just need to reside within a 100-mile radius of Boston and have an oncologist that the researchers can also work with. Moreover, the study now has a "Stage 2," so that 100% of participants have the opportunity to be part of the experiment employing the dose range of MDMA being evaluated as a treatment-level dose. To learn more about this study, either if you are curious or if you or someone you know may be interested in volunteering, see: http://clinicaltrials.partners.org/trials.aspx?tId=2284 April 10, 2009. Threshold Foundation Donates $8400, SAePT Donates 5000 to MDMA/PTSD Research: Ashawna Hailey, on MAPS’ Board of Directors, presented information about our MDMA/PTSD research to a Threshold Foundation meeting. The Threshold Foundation is a group of philanthropists who meet together to pool resources and discuss their charitable giving. Ashawna made a presentation that highlighted our MDMA/PTSD research as a tool to help treat veterans of war. We wish to thank Ashawna for her speech and we extend our gratitude to the members of Threshold Foundation for their $8400 donation. At their annual meeting on April 3, the Swiss Association for Psycholytic Therapy (SAePT) voted to donate 5000 Euros to the Swiss MDMA/PTSD study being conducted by Dr. Peter Oehen. We're grateful for this contribution and the international collaboration between MAPS and SAePT, whose members include both Dr. Oehen and Dr. Gasser. April 9, 2009.  MAPS sent a payment of $20,000 to our Swiss MDMA/PTSD study, conducted by Principal Investigator Peter Oehen, MD, and his co-therapist Verena Widmer, RN. The study has enrolled 10 subjects, with 2 subjects still in the treatment process and two more to be enrolled. The study will cost $225,000; $60,000 is still needed. March 7, 2009. MAPS Clinical research team members Valerie Mojeiko and Joshua Sonstroem are currently out "in the field" meeting with MAPS researchers around the world on a several week- monitoring trip. Valerie currently writes from Switzerland where they have just finished a visit with our MDMA/PTSD therapy site under the direction of psychiatrist Peter Oehen, MD and are currently working with psychiatrist Peter Gasser, MD at our LSD/end-of-life anxiety study. "I am amazed at how many regulations there are and how difficult it is to conduct this type of research accordingly," said Valerie, "Only with careful attention to detail are we able to succeed in keeping up with the regulations--the researchers in Switzerland have put much effort into this endeavor." These visits to the research sites not only keep our research compliant with International Council on Harmonization/Good Clinical Practice (international ethical and scientific quality standard for pharmaceutical research) (ICH/GCP) guidelines, but also serve as a way to communicate between research teams and identify training or resource needs and other opportunities. "It is great to see the data firsthand and to hear stories from the researchers of the people who were helped by this therapy--Im glad to be a part of this research," said Valerie. March 6, 2009. MAPS US MDMA/PTSD researchers, including Michael Mithoefer MD, Annie Mithoefer BSN, Mark Wagner PhD, Ilsa Jerome PhD, and Rick Doblin PhD, are preparing a paper about our U.S. pilot study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder, which has obtained impressive results The first draft of the paper is close to being sent out to friendly reviewers for initial scrutiny. We will submit the paper to a scientific journal after we respond to the critiques from colleagues and experts. The team is working diligently on the paper to ensure that we provide the eventual reviewers with a compelling submission. MAPS is very excited about the paper; now that we have run the data analysis our research results are really impressive. February 6, 2009. MDMA-Assisted Psychotherapy Helps Israeli Subject with PTSD from the 1967 Six-Day War: MAPS President Rick Doblin PhD is delighted to share the success of a recent MDMA-assisted psychotherapy session in Israel. Rick was told a remarkable story during a check-in with the therapy team that is conducting our Israeli MDMA-assisted psychotherapy for the treatment of Posttraumatic Stress Disorder (PTSD) study. Several weeks ago, the Israeli therapists successfully treated a patient who had suffered from PTSD for over 40 years, since the Six-Day War in 1967. On his second MDMA session, the gentleman became acutely aware of fears he was still harboring within him since the war. He requested to leave the treatment room for a walk outside on the hospital grounds. The therapists escorted him outside as he had a breakthrough catharsis leading to dramatic healing. Ironically, planes were flying overhead on the way to bomb Gaza. With so much new trauma being created, it may seem underwhelming to speak of treating only 12 subjects each in our Israeli and proposed Jordanian studies. Yet if successful, these pilot projects will lead to larger-scale studies. Furthermore, as Charles Mackay, author of Extraordinary Popular Delusions and the Madness of Crowds (published in 1841), observed, “Men, it has been well said, think in herds; it will be seen that they go mad in herds, while they only recover their senses slowly, and one by one.” The MAPS team is honored and humbled to help someone who has suffered for so long. We hope that in the near future MDMA-assisted psychotherapy will be available legally to all who suffer from PTSD. We believe that in the future, our successes in the laboratory will translate into a more peaceful world. Rick shared, “in the midst of war, we are developing the technologies of peace and healing.” February 3, 2009. Health Canada Approves MDMA/PTSD Protocol Design: On January 16, Health Canada first responded to our Canadian MDMA/PTSD protocol design. They accepted almost all elements of the protocol but had some items they wanted changed. We also asked for a change in the kind of previous treatments for PTSD the subjects will be required to have tried and failed. On January 20, we submitted our replies, accepting some changes and making our best argument for why it was important to include people who were free from substance abuse histories for the last 6 months rather than for the last 12 months, as Health Canada had suggested. In addition, we asked to be able to include subjects who failed on other psychotherapy and either tried and failed, or refused medication. Health Canada had suggested including only subjects who had failed on other psychotherapy, and had tried and failed to obtain relief from medication - excluding subjects who refused to try medication. On February 3, we heard from Health Canada that our responses had been accepted and that our protocol design had been fully approved (Hooray!). This shows yet again that it is possible to negotiate with regulatory agencies that put science first. On January 12, we heard from Health Canada’s chemistry reviewers. We’ve been gathering our replies ever since, which included obtaining a new analysis of the heavy metals and residue on ignition of the MDMA. In addition, Health Canada had a series of questions about the capsules, the lactose filler, and the bottles in which the capsules will be stored. On February 2, Professor Rudolph Brenneisen from Switzerland provided MAPS with documents regarding the chemical make-up of the MDMA that will be imported to Canada from Switzerland. Ironically, the last bit of information we need to gather is the batch number of the lactose! We expect to submit the required chemistry information in the next few days. Once the protocol is approved, we can start the process of obtaining the import/export permits for the MDMA from Switzerland, and can then start the study itself. January 20, 2009. Flagship US MDMA/PTSD Study Final Monitoring Visit: On January 20-22, MAPS’ clinical research monitoring team, Valerie Mojeiko and Josh Sonstroem, went to Charleston, South Carolina to conduct a closeout visit for MAPS’ flagship US MDMA/PTSD study. The data from this study is now ready to be submitted to FDA. With this ending also comes the beginning of the “long-term follow up” extension to this study. During this extension, subjects who were enrolled in the original study will be retested on primary outcome variables one year or more after completion. In the initial study, the last measurement of PTSD severity was taken two months after the last experimental session. Since this study took over four years to conduct, some of the data from the long-term follow-up will be from subjects who were treated over four years ago. The value of the long-term follow-up study will be substantially enhanced as a result of the extra length of time since treatment for most of the subjects. MAPS is pleased to have the help of volunteers Scott Martin MD and Mili Ballard to coordinate this long-term follow-up study. January 2, 2009. MAPS’ International MDMA/PTSD Research Progresses into the New Year. Our Swiss and Israeli MDMA/PTSD studies are continuing to recruit subjects. Our Swiss study has only a few subjects still to recruit while our Israeli study has more than half remaining to be recruited. Sadly, the current war in Israel is creating many more people with PTSD. For our proposed Jordanian MDMA/PTSD study, we’re in the process of having our informed consent form translated into Arabic for review by the Jordanian IRB. We’re also making progress toward obtaining the necessary insurance to conduct a study in Jordan.  December 19, 2008. The audio version of The Economist article about MAPS' Flagship MDMA/PTSD study is now available in MP3 format. December 18, 2008. MDMA/PTSD Documents Submitted to Health Canada. On December 18, all the documents for our Canadian study of MDMA-assisted psychotherapy in the treatment of people with Posttraumatic Stress Disorder (PTSD) were submitted to Health Canada (Canada’s version of the FDA). We've already obtained approval of our protocol and informed consent from a Canadian Institutional Review Board. We should receive a reply from Health Canada within 30 days of our submission. This is going to be a study with 12 subjects, similar in design to the recently completed US MDMA/PTSD study. Our main purpose for this particular study is to see if we can replicate the results of the US study. The budget for this study is $250,000, all of which remains to be raised. December 10, 2008. MAPS Releases Year-End MDMA Literature Review: As part of our ongoing clinical research responsibilities, MAPS reviews all of the MDMA- related articles published in scientific peer-reviewed journals to determine whether we need to modify our risk/benefit analysis for our clinical studies. We have now completed our review of the scientific literature published between December 2007 and November 2008 and submitted the review to the Institutional Review Board (IRB) that oversees our US MDMA/PTSD study. Nothing in the review changes our risk/benefit analysis regarding our research in human subjects. This review--along with all previous reviews--are compiled by MAPS Research Specialist Ilsa Jerome, and are posted on the MAPS website at: www.maps.org/mdma/protocol/litreview.html December 3, 2008. Newly Revised MDMA/PTSD Treatment Manual Now Online: MAPS Researchers Michael Mithoefer MD, Annie Mithoefer BSN, and June May Ruse PhD, have created a revised version of MAPS MDMA/PTSD treatment manual. The new version of the manual builds on a previous manual from 2005, and includes lessons learned from our recently completed US MDMA/PTSD pilot study. The team of researchers reviewed many hours of videotapes of the therapy sessions with the aim of finding clear examples of the key elements of the therapeutic method. The manual will be continually revised as we identify best practices and gather data to link methods to outcomes. The manual, will also be used to develop measurement tools for identifying key elements of the therapeutic method. The treatment manual, selected excerpts of the videotapes, and the measurement scales of the key elements of our therapeutic method, will form the core of our therapist training program for the male/female co-therapist teams who will conduct MAPS Phase 3 multi-site studies. We anticipate sponsoring studies in 20-30 different locations across the US, Europe, Israel and Jordan. December 2, 2008. A family foundation that wishes to remain anonymous donated $50,000 to MAPS for our US MDMA/PTSD research. The foundation had generously supported our US MDMA/PTSD study during the early stages of the research – giving substantial donations that played a crucial role in launching this project. In addition, long-time MAPS supporter Tim Butcher (profiled in MAPS Bulletin article), is donating $17,000 to our US MDMA/PTSD study, with an initial donation of $5000 and $1,000 a month for the next year. MAPS Researcher Michael Mithoefer, MD expressed his appreciation to these donors and noted, “Because MDMA can’t be patented these studies are not going to be funded by for-profit pharmaceutical companies. So far we have not been able to get government funding, and I don’t expect that to change in the foreseeable future. Contributions like yours are making it possible for us to complete the analysis and dissemination of our results and to now move forward with development of a training program, new protocols and teams of therapists and other researchers to perform a multi-center study. We are continually encouraged and deeply touched by the level of support MAPS is receiving for this work. The fact that this research can be accomplished by a small non-profit organization supported by a community of people who recognize the healing potential of MDMA and the importance of rational government policy based on science is quite extraordinary. This effort has already made a huge difference in the lives of the people with severe PTSD who participated in the study. I especially want to communicate that fact to you because you are playing a significant role in making it possible.” November 11, 2008. MDMA/PTSD Study With War Veterans In The Planning Stage: The European Medicines Agency has recently issued guidelines for sponsors interested in developing drugs to treat PTSD. The PTSD guidelines suggest that research be conducted in subgroups of people with PTSD, grouped according to the cause of their PTSD, for example, sexual assault or war-related PTSD. The purpose of such research is to identify if PTSD that is caused by a different type of trauma (i.e. sexual assault, war) responds to a specific treatment with similar or different success rates. If the treatment appears to have similar efficacy across subgroups, then people with PTSD from different causes can be enrolled in the same Phase 3 study but if the treatment is different, the Phase 3 studies should each be in a homogenous group of subjects by cause of PTSD. As a result of the EMEA guidelines, MAPS, Michael Mithoefer MD, and Annie Mithoefer BSN will soon start the design and approval process for a new study investigating subjects whose PTSD is a result of war trauma. This study will include seven veterans, four women and three men, so that we can also gather some preliminary information on possible gender differences in response to MDMA-assisted psychotherapy. November 7, 2008. Canadian IRB Gives Conditional Approval To MDMA/PTSD Protocol: On Friday, November 7 the Canadian Institutional Review Board (IRB) granted conditional approval for our MDMA/PTSD protocol. The conditions are relatively easy to meet. We must have resuscitation equipment at the research clinic, confirm that study staff will possess previous practical experience with psychological distress, especially with respect to psychedelic drugs, and add a tool for the assessment of subjects’ suicidal risk (e.g., suicidal ideation) to provide a more structured evaluation. We are now selecting a preferred measure for assessing suicide risk. We are also now preparing documents to be submitted to Health Canada (Canada’s version of the FDA). The IRB met on Wednesday, November 5 to review our replies to changes previously requested by the IRB. The IRB reviewed our responses and approved them. We replied to issues related to the open label stage of the protocol, the age of enrollment, and prior substance abuse history of subjects. The IRB agreed that we can retain the open label stage 2 portion of the protocol—the portion of the protocol in which everyone who was randomized to placebo in Stage 1 receives open label MDMA in the Stage 2. The inclusion of an open-label Stage 2 in our protocol has multiple purposes: 1) The therapist can better learn the contribution that MDMA itself plays in MDMA-assisted psychotherapy by treating patients who initially received placebo (psychotherapy without a full dose of MDMA); 2) It is scientifically valuable since subjects who receive placebo initially act as their own controls; 3) It helps with recruitment and retention of subjects, since subjects know that by participating in the study they will eventually get the opportunity to receive MDMA-assisted psychotherapy We reached a compromise agreement with the IRB on the age of enrollment and prior substance abuse history. Subjects must be 21 years old to enter the treatment and cannot have abused drugs during the six months leading up the treatment. We also shortened the length of the informed consent form, as requested. Our success with the Canadian IRB is an important milestone in our march toward the globalization of MDMA/PTSD research. October 15, 2008. The fortieth edition Journal of Psychoactive Drugs published an article “MDMA-Assisted Psychotherapy Using Low Doses in a Small Sample of Women with Chronic Posttraumatic Stress Disorder” by José Carlos Bouso PhD candidate, Rick Doblin PhD, Magí Farré MD PhD, Miguel Ángel Alcázar PhD, and Gregorio Gómez-Jarabo PhD. This article reports on the MAPS-sponsored MDMA-assisted psychotherapy study in Spain that was prematurely shut down by the Spanish government. The abstract of the article is as follows: “The purpose of this study was to investigate the safety of different doses of MDMA-assisted psychotherapy administered in a psychotherapeutic setting to women with chronic PTSD secondary to a sexual assault, and also to obtain preliminary data regarding efficacy. Although this study was originally planned to include 29 subjects, political pressures led to the closing of the study before it could be finished, at which time only six subjects had been treated. Preliminary results from those six subjects are presented [in the article]. We found that low doses of MDMA (between 50 and 75 mg) were both psychologically and physiologically safe for all the subjects. Future studies in larger samples and using larger doses are needed in order to further clarify the safety and efficacy of MDMA in the clinical setting in subjects with PTSD.” October 10, 2008. From October 6-10, 2008, Michael Mithoefer MD, Annie Mithoefer BSN, and June May Ruse PhD, worked on the MDMA/PTSD treatment manual. This was their second week working together in person, with a third week anticipated in December or January. They have reviewed many hours of videotapes of therapy sessions from Michael and Annie’s recently completed US MDMA/PTSD pilot study, with the aim of finding clear examples of the key elements of the therapeutic method. They intend to develop scales of approximately ten key elements of the therapeutic method. These scales would then be used by raters to evaluate researchers/therapists’ adherence to our specific therapeutic method. The treatment manual, selected excerpts of the videotapes, and the scales of the key elements of our therapeutic method, will form the core of our therapist training program for the male/female co-therapist teams who will conduct MAPS’ Phase 3 multi-site studies. We anticipate sponsoring studies in 20-30 different locations across the US, Europe, Israel and Jordan. October 7, 2008. On October 7, 2008, MAPS sent a draft of a protocol for a MAPS-sponsored MDMA/PSTD pilot study to Royal Jordanian Military psychiatrist Nasser Shuriquie. Dr Shuriquie needs to show the protocol to other medical officials to gauge whether there is sufficient support to justify submitting a final draft of the protocol to a Jordanian Ethics Committee and the Jordanian Ministry of Health. This version of our protocol differs from other pilot studies in several ways. It begins with a three-subject open label run-in in which both the subjects and the therapists know that MDMA is being administered. In this way, the therapist gets a chance to practice our therapeutic technique and become familiar with the therapeutic process before administering MDMA or placebo to other subjects in the context of a placebo-controlled, randomized, double-blind study. We believe that it is important for the therapist to get a chance to become comfortable with the procedure prior to starting a controlled study. The remainder of the protocol is a nine-person study, where six subjects receive three sessions of full-dose MDMA, 125 mg followed one-and-a-half to two-and-a-half hours later by 62.5 mg. Three subjects would receive active placebo, in this case 40 mg followed 1.5-2.5 hours later by 20 mg. Our Swiss, Israeli and Canadian MDMA/PTSD pilot studies are using 25 mg as the active placebo while our US study used an inactive placebo. September 17, 2008. On September 17, 2008, French psychiatrists Olivier Chambon and Fred Rosenfeld met with Patrick Lemoine MD in Lyon, France to discuss possibilities of starting a MAPS-sponsored MDMA/PTSD pilot study at a clinic where they work and that Dr. Lemoine directs. MAPS President Rick Doblin PhD and Director of Operations Valerie Mojeiko spoke in Paris in March 2008 at a conference about hallucinations in an attempt to catalyze MDMA/PTSD research [Link to article in current MAPS Bulletin on page 17]. On June, 28 2008, Valerie and Josh Sonstroem, MAPS’ Clinical Research Associates, conducted a site visit at the clinic where Drs. Chambon and Rosenfeld work. After meeting with Drs. Chambon and Rosenfeld, Dr. Lemoine was intrigued but raised some concerns about MDMA neurotoxicity and cardiotoxicity. We sent detailed scientific information about those risks and await news as to whether we can move to the next stage of the project, which would be to develop a protocol that would be submitted to an Ethics Committee and the French Ministry of Health September 16, 2008. The Institutional Review Board that is reviewing our Canadian MDMA/PTSD study sent us a letter dated September 16, 2008, requesting a few changes to the protocol we submitted (PDF) . We were delighted to receive this letter since it is clear now that the study itself will be approved. The IRB has some issues of concern that need a further exchange of information before being resolved. The issues of concern relate to the open-label stage 2 portion of the protocol, the age of enrollment, and prior substance-abuse history of subjects. In addition, the Canadian IRB stated that our informed consent form was too long and detailed for subjects to fully comprehend and needed to be significantly shortened. This is in stark contrast to our United States IRB, which wanted an exhaustive informed consent form. The US form was so long that we instituted a non-graded quiz at the end to make sure that the subjects understood the nature of the risks of MDMA-assisted psychotherapy and the key elements of the study design. We are gathering letters of support for the Canadian protocol from various experts, and will respond soon to the IRB’s concerns. Once the IRB approves a final version of the protocol and informed consent, we will then submit it to Health Canada – Canada’s version of the FDA. We hope to have this study fully approved and ready to begin in early 2009. The budget for this study is $150,000, all of which remains to be raised. September 8, 2008. MAPS has just sent to a Canadian Institutional Review Board (IRB) a protocol for a randomized, active -placebo controlled, double-blind study of MDMA-assisted psychotherapy for people with PTSD to take place in Vancouver BC. July 6, 2008. The Sunday Baltimore Sun published an editorial ("Tuning In, Not Out") supporting research into the therapeutic potential of psychedelics. The editorial mentions the MAPS-supported research into MDMA-assisted psychotherapy in people with PTSD and ends by stating, "Instead of banning drugs that are perceived as bad simply because of their recreational use, scientists should be encouraged to pursue legitimate study - lest we miss out on a valuable medicinal tool." May 4, 2008. The Sunday Times (London) recently published "Ecstasy is the Key to Treating PTSD," an in-depth piece on MDMA-assisted psychotherapy in people with PTSD, focusing on Dr. Mithoefer's MAPS-supported study and featuring quotes from MAPS president Rick Doblin and British psychiatrist Ben Sessa. April 3, 2008. The list of articles and information on potential risks of MDMA now includes a report of estimated risk of MDMA in people with hepatitis C. While there is nothing in the medical literature on the topic, this report draws on information about MDMA, heptatitis C, and drugs used to treat it. February 6, 2008. A letter by Krebs and Johansen commenting on and questioning the findings of the prospective study of cognitive function in ecstasy users is now published in the Archives of General Psychiatry. The letter addresses issues relating to the nature of the test score differences, the existence of long-term retest effects, participant durg use history and effects of anxiety arising from stereotype threat. Schilt and colleagues' reply appears alongside the letter. They respond to questions concerning retest learning effects and re-analyze data with respect to drug use history. Krebs and Johansen are conducting an examination of psychological defense mechanisms in experimental sessions from Mithoefer's randomized, placebo-controlled study of MDMA-assisted psychotherapy in people with PTSD. November 30, 2007. MDMA is not a type of methamphetamine: Despite its title, the recent Science Daily piece "Club Drugs Inflict Damage Similar To Traumatic Brain Injury" is about studies on the effects of methamphetamine, not MDMA, and describes findings in rats, not people. Read a brief commentary on this news report. November 29, 2007. Sessa and Nutt have recently published an editorial in the Journal of Psychopharmacology, "MDMA, politics and medical research: Have we thrown the baby out with the bathwater?", speaking out against the effects of politics and regulation on medical research with MDMA and in favor of more basic and medical research. In their editorial, Sessa and Nutt discuss the costs to the research enterprise imposed by regulation of MDMA, and proposes at least three avenues of further research. The piece is provocative and uneven, but makes for encouraging reading for supporters of MDMA psychotherapy research. November 25, 2007. Washington Post magazine published an article (MAPS PDF Permalink) featured as the cover story about MAPS’ and Dr. Michael Mithoefer’s MDMA-PTSD research entitled "Peace Drug". This article is overall positive with one minor mistake--the idea of MDMA being prescribed only by specially trained therapists in psychedelic clinics is attributed to Dr. Michael Mithoefer when it should have been attributed to Rick Doblin Ph.D.’s dissertation. This article is unique as it is the first time that a reporter has been allowed to interview a research participant from this historic study. You can read the comments about this article here. October 12, 2007. MAPS communications director Jag Davies conducted a podcast interview (mp3) with Dr. Michael Mithoefer, in which Dr. Mithoefer discusses the details of his study, his working relationship with wife and co-therapist Annie Mithoefer, and his musings on the psychological mechanisms involved in MDMA-assisted psychotherapy. October 10, 2007. Sixteen out of twenty subjects have completed the double-blind protocol in Dr. Michael Mithoefer's flagship MAPS-sponsored FDA Phase 2 study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder (PTSD). Three new subjects have been enrolled, two of which are close to completion of the first stage of the protocol. One of these new subjects is a US military veteran whose trauma occurred during combat in Iraq. Last month, MAPS and Dr. Mithoefer submitted a protocol amendment to FDA, seeking approval to treat a 21st subject, also a US veteran with PTSD from the Iraq War. We need FDA permission to deviate from our inclusion criteria that requires all PTSD subjects to be treatment-failures from both drug and non-drug treatments. The FDA has accepted our request, which we have just submitted to our institutional review board (IRB) for final review. October 1, 2007. American Medical News published a feature article entitled "Altered Perceptions: Good Outcomes from 'Club Drugs'"? MAPS President Rick Doblin, PhD, and researchers Michael Mithoefer, MD, John Halpern, MD, and Charles Grob, MD, are quoted. American Medical News is a weekly newspaper for physicians published by the American Medical Association that is ciculated to over 230,000 physicians and health policy regulators. September 3, 2007. MAPS and Dr. Mithoefer submitted a protocol amendment to FDA, seeking approval to treat a 21st subject, a US veteran with PTSD from the Iraq War. We need FDA permission to deviate from our inclusion criteria that requires all PTSD subjects to be treatment-failures from both drug and non-drug treatments. The request to include a subject who is not a treatment-failure is due to the sad fact that this veteran, like several others with whom we have spoken, has been diagnosed with PTSD but has never been offered treatment by the military. We expect to hear from FDA in a few weeks. Michael Mithoefer, MD, and Annie Mithoefer, BSN, have enrolled 18 out of 20 subjects in their MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic PTSD. Another two potential subjects are currently in the screening process. The completion of MAPS' flagship FDA Phase 2 clinical research study is now in sight. July 10, 2007. No cause for alarm: Despite claims to the contrary, the recently published meta-analysis of studies of memory in ecstasy users does not demonstrate that memory is impaired even after a few doses of ecstasy. Here are our conclusions reached after reviewing the paper and correspondence with one of the study authors. June 27, 2007. Yesterday, June 26, the 17th subject out of 20 completed the first experimental session in Dr. Michael Mithoefer's MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post traumatic stress disorder (PTSD). We are still actively seeking to enroll in the study at least two US veterans with PTSD from the Iraq or Afghanistan wars. This Phase II clinical study is the first-ever FDA-approved human study evaluating MDMA's therapeutic applications. Efficacy data is extremely promising so far, making a strong case for continuing research into FDA Phase III studies. June 26, 2007. News coverage of a soon-to-be published research report in the journal Human Psychopharmacology vary in depth and accuracy, with some claiming "Even Low ecstasy use harms memory," or "Taking Ecstasy Once can Damage Memory", while others provide more details suggesting that this is not the case. The research in question is a meta-analysis of previous research studies. Read initial comments and reflections on the news coverage and research report. June 19, 2007. On June 3, MAPS-sponsored researchers Michael Mithoefer, MD, Annie Mithoefer, RN, Peter Oehen, MD, and Verena Widmer, RN, presented on MDMA-assisted psychotherapy research at the European Conference on Traumatic Stress in Croatia. Also present at the conference was Swiss researcher Dr. Franz Vollenweider, who is conducting a physiological study of the subjects in the Swiss MDMA/PTSD study, measuring markers for PTSD before and after treatment. MAPS' MDMA/PTSD research now has preliminary data to share with PTSD researchers around the world. June 5, 2007. The Netherlands XTC Toxicity (NeXT) research team has published yet one more prospective report of ecstasy users and non-users. In contrast to their earlier efforts, this report on attention and memory claims to have found differences between the two groups, with non-users performing better on verbal memory tests. However, the report contains problems both with the analysis and interpretation of the data. May 16, 2007. The latest data from one of the first studies to compare people before and after they used ecstasy, part of the Netherlands XTC Toxicity (NeXT) research program, has just appeared in the second of two reports. Like the first findings reported from this study, the subsequent report also failed to find any indications that ecstasy in low doses impaired selective attention or working memory, and found no ecstasy-use related changes in brain activation either. May 15, 2007. We have learned that the data being generated from the Swiss and Israeli MAPS-sponsored studies will be accepted by the US FDA. Although these protocols do not need to be approved by the FDA to be conducted in their home countries (they have already been approved by their home country's regulatory agency equivalent to FDA and by local ethics committees), FDA review and approval enables us to submit to FDA the data from these two studies as part of MAPS' Investigational New Drug (IND) application for MDMA-assisted psychotherapy in the treatment of PTSD. The data from these studies will be used to help negotiate with FDA regarding the design of larger Phase 3 studies intended to gather data to determine whether or not MDMA meets the requirements necessary to be approved as a legal prescription medicine. To learn more about the MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war- and terrorism-related PTSD, the protocol is posted on the MAPS Web site. To learn more about the MAPS-sponsored MDMA/PTSD study in Switzerland, the protocol is also posted on the MAPS Web site. May 13, 2007. Dr. Michael and Annie Mithoefer, the co-therapists for MAPS' landmark US MDMA/PTSD study, were in Norway recently attending a workshop by Dr. Edna Foa, an internationally-recognized expert in the treatment of PTSD. The workshop was organized by Pal-Orjan Johansen, a Ph.D. candidate at the Trondheim Psychotherapy Research Program, Department of Psychology, The Norwegian University of Science and Technology, and Teri Krebs, B.S., Program in Neuroscience, Boston University. While in Norway, Dr. Michael and Annie Mithoefer were also able to work with Pal and Teri, who are conducting a MAPS-sponsored study reviewing audio and video recordings and transcripts of subjects in the Mithoefer's MDMA/PTSD research, in order to code and compare the psychological defense mechanisms used in both non-drug therapy sessions and in the experimental MDMA-assisted therapy sessions. This study is designed to identify process variables that may help explain how MDMA can be a useful adjunct to psychotherapy. Dr. Michael and Annie Mithoefer were also able to discuss with Pal and Teri their MAPS-sponsored project using the internet to search for reports of people with Asperger's (a form of high-functioning autism) who have found MDMA to be helpful in their learning to cope more effectively in social situations. If we do find at least a handful of such reports, this could become another area of research, if funding becomes available. Drs. Mithoefer, Peter Oehen and Franz Vollenweider, will be presenting their MDMA/PTSD work at the European Conference on Traumatic Stress in Croatia next month. April 13, 2007. The MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war-and terrorism-related posttraumatic stress disorder (PTSD) has full government approval and is now in the subject recruitment stage. The study will be conducted at Beer Yakhov Mental Health Center, near Tel Aviv, under the direction of Principal Investigator Moshe Kotler, M.D., former chief psychiatrist of the Israeli Defense Forces. The therapeutic team has been expanded and will now include Sergio Marchevsky, M.D., in addition to Rakefet Rodrigez, M.D., and Rael Strous, M.D. March 20, 2007. Time Magazine's annual "What's Next" issue ran a brief story entitled "Taking a trip for your mental health," highlighting MAPS-sponsored MDMA, psilocybin, and ketamine research. March 17, 2007. An encouraging advancement is that we may be close to enrolling the final five subjects needed to complete Dr. Mithoefer's study. We've focused more attention on recruitment with ads on various psychedelic-related websites and websites for PTSD support groups and currently have more than five subjects going through the screening process. Two of these potential subjects are Iraq War veterans. Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies. March 11, 2007. After several years of effort, three rejections, and an appeal, the Institutional Review Board (IRB) for Dr. Michael Mithoefer's flagship MAPS-sponsored US MDMA/PTSD study approved an amendment to the study's protocol. The IRB decided that it will not object to subjects speaking with the media and/or documentary filmmakers following completion of each subject's participation in the study. The IRB originally insisted that patients not speak with the media even after the entire study is complete. After years of careful consideration, the IRB has now determined that it has no jurisdiction to control subjects' decisions about whether or not to speak to the media. Now that the media policy has been resolved, we are ready to move forward with our 12-month follow-up evaluations, which the IRB has previously approved. March 10, 2007. Dr. Peter Oehen's MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic posttraumatic stress disorder (PTSD) has been making swift progress. Last Thursday, March 8, the second subject in Dr. Oehen's study underwent the second experimental treatment session. The third subject will undergo the first experimental session later this week, and the fourth and 5th subjects have already been recruited. March 6, 2007. Peter Jennings' special ABC report entitled Ecstasy Rising is available for viewing. This groundbreaking documentary discusses MDMA's cultural history, its use as a therapeutic tool, the government's criminalization and exaggeration of its risks, and MAPS' recent success with MDMA-assisted psychotherapy research. Regarding this clip we would like to give SPECIAL thanks to Nathan for ripping this footage and hosting it onsite ;-) Many gracious THANX...! February 28, 2007. MAPS has committed $5,300 to Dr. Franz Vollenweider at the Psychiatric University Hospital in Zurich to co-sponsor a secondary study that will gather data for physiological assessments of subjects in Dr. Oehen's MDMA/PTSD study. The additional study will use several different measures to assess the psychophysiology of PTSD by using EEG/ERP and other biological measures such as heart rate variability (HRV) and pre-pulse inhibition (PPI). These parameters will be measured before and after the MDMA-assisted psychotherapy to allow researchers to evaluate changes in various areas of the brain and body. We expect that this additional neurophysiological and biological data will document the efficacy of MDMA-assisted psychotherapy. The amendment to Dr. Oehen's protocol to include Dr. Vollenweider's research was previously approved by Dr. Oehen's Ethics Committee (IRB) in September 2006. For more on this study, see Dr. Oehen's article in the Fall 2006 MAPS Bulletin. February 26, 2007. The UK's Sky News published a short article describing Dr. Peter Oehen's MAPS -sponsored pilot study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder (PTSD). February 14, 2007. Swiss Radio International's Swissinfo published a brief original article describing Dr. Peter Oehen's ongoing MAPS-sponsored pilot study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder. February 9, 2007. The Data Safety Review Board (DSMB) for Dr. Michael Mithoefer's MAPS-sponsored FDA Phase 2 pilot study evaluating MDMA-assisted psychotherapy for subjects with posttraumatic stress disorder (PTSD) met in late January for its final review, now that 15 out of 20 subjects have completed the experimental treatment. The DSMB recommended that the study continue without modification. Ironically, the DSMB's only safety concern was that those subjects who received the placebo might see a substantial increase in PTSD symptoms after tapering off of psychiatric medications. The DSMB is comprised of an M.D., a Psy.D. and a Pharm.D. not otherwise involved in the study. Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies. We're already looking beyond the next five subjects and the completion of this initial study, to future research protocols. January 23, 2007. Slate published a positive description of MAPS' MDMA drug development efforts in a front page article entitled "What a Long, Strange Trip It's Been: Ecstasy, the New Prescription Drug?" January 12, 2007. MAPS has donated $3000 to Pal-Orjan Johansen and Terri Krebs for a project that will seek to use the internet to search for reports of people with Asperger's (a form of high-functioning autism) who have found MDMA to be helpful in their learning to cope more effectively in social situations. If we do find at least a handful of such reports, this could become another area of research, if funding becomes available. MAPS also awarded another grant of $6000 to Pal-Orjan Johansen and Terri Krebs to expand their work reviewing transcripts of subjects in MAPS-sponsored MDMA/PTSD research, in order to code and compare the psychological defense mechanisms used in both non-drug therapy sessions and in the experimental MDMA-assisted therapy sessions. This study is designed to identify process variables that may help explain how MDMA can be a useful adjunct to psychotherapy. January 6, 2007. From January 3-6, 2007, MAPS' clinical research team (Amy Emerson, Valerie Mojeiko, and Josh Sonstroem) was in Charleston, SC, conducting a monitoring inspection of Dr. Michael Mithoefer's MAPS-sponsored IRB-, DEA-, and US FDA-approved MDMA/PTSD study. On January 5, the 15th subject participated in her third and final experimental MDMA-assisted psychotherapy session. On January 6, MAPS President Rick Doblin visited Charleston to meet with Dr. Michael and Annie Mithoefer and MAPS' clinical research team to review the data, which looks very promising. An additional $125,000 will be required to complete this study. December 14, 2006. In response to the sensationalistic and inaccurate recent news coverage of prospective Ecstasy user studies by Dutch researcher Dr. Maartje M. de Win, MAPS President Rick Doblin, Ph.D. wrote this open letter to Dr. de Win voicing his concerns, and MAPS Clinical Research Associate Ilsa Jerome, Ph.D., wrote a special report evaluating the media's claims and how they relate (or not) to the actual data. December 8, 2006. While in Thailand to testify in a medical MDMA trial, MAPS President Rick Doblin took the opportunity to do an interview with The Nation, Thailand's largest English-language daily newspaper. In the interview, Doblin speculates on the possibility of conducting MDMA/PTSD research with tsunami victims and discusses MAPS' international psychedelic research agenda. November 24, 2006. Dr. Peter Oehen conducted the second experimental MDMA-assisted psychotherapy session with the second subject in his ongoing MAPS-sponsored MDMA-assisted therapy pilot study for subjects with treatment-resistant post-traumatic stress disorder (PTSD). According to Dr. Oehen, the subject delved into some challenging content, but the long-term results appear to be quite positive. "She was confronted very hard with anxiety, negative emotions related to the sexual abuse and especially her isolation and avoidance of closeness," said Dr. Oehen. "It was hard work for her in the following days but since then she has made substantial progress". Therapist reports confirm that the subject "confronted very hard with anxiety and with negative emotions related to their tramua - especially isolation and avoidance of closeness." This was followed by "hard work for the subject during the following days but since then they have made substantial progress." October 23, 2006. The MDMA arrived on-site today at Harvard's McLean Hospital for Dr. John Halpern's MAPS-initiated study evaluating MDMA-assisted psychotherapy for subjects with advanced-stage cancer suffering from end-of-life anxiety disorders. MAPS has withdrawn from direct sponsorship of this study, but will still have access to the data generated by Dr. Halpern, as will any other organization that requests it. October 22, 2006. The MAPS clinical research monitoring team arrives in Israel today for the Site Initiation visit for the MAPS-sponsored MDMA/PTSD pilot study at Beer Yakhov Mental Health Center in Tel Aviv, Israel, under the direction of Principal Investigator Moshe Kotler, former chief psychiatrist of the Israeli Defense Forces. The study will focus on individuals suffering from war-related PTSD. The MAPS clincial monitoring team consists of MAPS President Rick Doblin, Ph.D., Clinical Research Associate Valerie Mojeiko, and volunteer clinical research expert Amy Emerson. Their job is to help the researchers prepare the study to fit the strict guidelines necessary for the data generated to be eligible for consideration by the FDA and the European Medicines Agency. On October 25, Doblin and Lester Grinspoon, M.D., will join Israeli and Palestinian drug policy experts in Jerusalem to talk at the first Arab-Israeli Joint Conference on Peace and Drug Policy, sponsored by the Ale-Yarok ("Green-Leaf") Party. The conference will focus on issues related to the cultural impacts of marijuana, its regulation, and its medical uses and research. While in Israel, MAPS staffers Rick Doblin and Valerie Mojeiko will also be conducting a "Psychedelic Emergency Services" training seminar for a team of volunteers organizing a rave near the Dead Sea. October 19, 2006. Principal Investigator Peter Oehen, M.D., officially initiated the Swiss MAPS-sponsored pilot study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant posttraumatic stress disorder (PTSD). Today, Dr. Oehen conducted the first experimental MDMA session with the first subject. Congratulations, Dr. Oehen! September 13, 2006. Dr. Michael Mithoefer treated the 13th subject with a third MDMA-assisted psychotherapy session today in his MAPS-sponsored FDA Phase II pilot study of MDMA-assisted psychotherapy for individuals with treatment-resistant post-traumatic stress disorder (PTSD). The 16th patient out of 20 was also just screened and admitted to the study earlier this week. September 12, 2006. Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD protocol has full government approval and the first subject began the screening process last week. The Ethics Committee (the Swiss IRB equivalent, which previously approved Dr. Oehen's MDMA/PTSD protocol) met on September 7 to review an addendum to the protocol, and we just learned today, September 12, that the IRB has granted approval, meaning that the study can now officially be initiated! The addendum is for an associated study by Dr. Franz Vollenweider, University of Zurich, that will examine subjects before and after treatment with MDMA-assisted psychotherapy. Dr. Vollenweider is going to measure several physiological factors that have been associated with PTSD (startle response, heart rate reactivity) as well as various EEG parameters to see if the MDMA-assisted psychotherapy results in any changes in these measures. The first applicant for the study will be administered baseline CAPS and PDS tomorrow, and, now that we have full approval, we hope to report shortly that the first subject has been treated with MDMA-assisted psychotherapy. August 21, 2006. The Norwegian Research Council website recently posted "Ecstasy: Historien Starter" (article in PDF format) (English translation "Ecstasy; The History Begins"), an article by Pål-Ørjan Johansen that discusses the scheduling history, the research controversies, and new research into the therapeutic potential of MDMA. August 20, 2006. VG, one of the largest Norwegian newspapers, published a very positive piece on MDMA psychotherapy research that includes interviews with Charles Grob, M.D., and Pål-Ørjan Johansen, Ph.D. (View PDF of article). August 18, 2006. The Guardian reports on Merck's official history of MDMA, as recounted in a recently published paper in the journal Addiction. August 15, 2006. In their "Newsdesk" section, the journal Lancet Neurology published "Hallucinogen Research Inspires Neurotheology," a report on developments in research with psychedelic compounds, such as ketamine or psilocybin. The piece contains comments from Roland Griffiths, John Halpern and Deborah Mash. August 5, 2006. The Israeli Import Permit and the Swiss Export Permit have now been approved. On Thursday, August 3rd, in the midst of war, about 5 grams of MDMA arrived in Israel for MAPS' MDMA/PTSD study, imported into Israel from Switzerland. This study has full government approval and will be initiated in Fall 2006. July 21, 2006. Dr. Michael and Annie Mithoefer treated the 13th subject with the second experimental MDMA/placebo session in their MAPS-sponsored MDMA/PTSD trial today. Dr. Mithoefer described it as "impressive." June 17, 2006. Switzerland's DEA equivalent, the BAG, has officially approved Dr. Peter Oehen's MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a treatment for subjects suffering from treatment-resistant Posttraumatic Stress Disorder (PTSD). Permission from BAG was the final regulatory hurdle, since Dr. Oehen has already received approval from the Ethics Committee (Switzerland's IRB equivalent) and SwissMedic (Switzerland's FDA equivalent). June 16, 2006. Dr. Michael Mithoefer initiated the first experimental MDMA-assisted psychotherapy session with the 13th subject out of 20 in his MAPS-sponsored FDA Phase II pilot study. This subject was the first to receive supplemental dosing of half the initial amount of MDMA administered 2 to 2.5 hours after the initial dose in order to prolong the plateau of MDMA's therapeutic effectiveness, a change recently approved by Dr. Mithoefer's Istitutional Review Board (IRB), the Food and Drug Administration (FDA), and the Data Safety Monitoring Board (DSMB). The supplemental dose did not seem to intensify the already strongly therapeutic experience but it did prolong the period of maximum therapeutic effect for at least 90 minutes. This appeared to be very useful. We were also happy to see that, as expected, there was no problem with vital signs. June 7, 2006. Switzerland's FDA equivalent, SwissMedic, has now fully approved Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD study. The protocol design had already been approved, and earlier this week we received approval for the source of the MDMA itself, which MAPS is purchasing from a Swiss manufacturer. Now that Dr. Oehen has received permission from SwissMedic and an Ethics Committee (the Swiss IRB equivalent), the only regulatory hurdle remaining is licensing from BAG, the Swiss DEA equivalent, which is expected within a month. Initiation of Dr. Oehen's study will take place shortly thereafter. Approval from SwissMedic of the source of the MDMA for the Swiss MDMA/PTSD study will now enable MAPS to move forward with the export of MDMA from Switzerland to Israel. The import/export of the MDMA is the last regulatory step in the initiation of Dr. Moshe Kotler's MAPS-sponsored MDMA/PTSD research at Beer Yaakov Mental Health Center in Tel Aviv, in subjects with war and terrorism-related PTSD. June 4, 2006. Dr. Michael Mithoefer has received Institutional Review Board (IRB) approval for several key changes that FDA had recently approved to his MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. The changes include (1) adding a third experimental session to the two that are currently included in the protocol to test whether a third session adds significantly to the therapeutic process, (2) providing supplemental dosing of half the initial amount of MDMA administered 2 to 2.5 hours after the initial dose in order to prolong the plateau of MDMA's therapeutic effectiveness, and (3) doing without an ER doctor on standby in the next room since Dr. Mithoefer has become a board-certified ER doctor as well as a board-certified psychiatrist. Now that the Data Safety Monitoring Board (DSMB), FDA, and IRB have all approved these changes to our protocol, they will be implemented for the study's remaining eight subjects. May 15, 2006. The Boston Globe published "A Good Death", an article that discussess the resurgence of interest in studying MDMA and psychedelic drugs to help people with cancer deal with anxiety and pain. The piece describes research MAPS helped design and locate funding for that will look at the potential therapeutic benefits of MDMA in people who are anxious as a result of advanced stage cancer. The latest MAPS Bulletin contains an article about the woman described in this article who used MDMA to treat cancer-related pain and anxiety. A PDF of the this piece is now available.. April 14, 2006. A recently published editorial in the Lancet supports research into the potential therapeutic benefits of psychedelic drugs and calls for a new legal structure that makes this research easier and less burdensome to conduct. The Lancet editorial was likely inspired by a commentary published in the British Journal of Psychiatry. This editorial was then covered by the British newspaper, the Guardian. April 5, 2006. In some fantastic news, philanthropist Peter Lewis has agreed to donate $250,000 directly to Harvard Medical School-affiliated McLean Hospital to fund the costs of Dr. John Halpern's study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. Dr. Halpern's MDMA/cancer anxiety study is already fully approved by the FDA, DEA, two Institutional Review Boards (IRB's, at Lahey Clinic and McLean Hospital) and the Massachusetts Dept. of Public Health. Now that the study is fully funded, Dr. Halpern is preparing to initiate the study and hopes to enroll the first subject within the next several months. As we reported in the last email update, MAPS has withdrawn from direct sponsorship of this study. The McLean Hospital administration felt that MAPS long-term advocacy for MDMA psychotherapy research and general opposition to Prohibition would cause the results of the study to be challenged as biased if MAPS were to sponsor the study and they did not want McLean Hospital to be involved in a study funded by MAPS. Therefore, we decided that it would be best for MAPS to offer to withdraw from further direct financial sponsorship of Dr. Halperns research so that the study, which many people labored so long to start, could proceed. Sacrifices sometimes need to be made. In this case, we decided that the benefits of the study moving forward substantially outweigh MAPS' withdrawal from direct sponsorship. MAPS will still have access to the data generated by Dr. Halpern, as will any other organization that requests it. March 7, 2006. The DEA has, after over one year, issued a license for Dr. John Halpern's study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. The final regulatory approval has thus been obtained. Additional approvals have already been received from two Institutional Review Boards (IRB-McLean and Lahey Hospitals) as well as the Food and Drug Administration (FDA) and the Massachusetts Department of Public Health. MAPS has donated over $94,000 to McLean Hospital over the last five years in an effort to initiate the evaluation of MDMA-assisted psychotherapy. One fruit of this support has been Dr. Halpern's $1.8 million grant from the National Institute on Drug Abuse (NIDA) for a methodologically state-of-the art study started with MAPS funding of the neurocognitive consequences of the use of Ecstasy. Now that the MDMA/cancer anxiety study is fully approved, MAPS is withdrawing from any further financial sponsorship. MAPS, independent of McLean and Dr. Halpern, still hopes to assist with seeking donors interested in now donating directly to McLean Hospital. We believe that this financial distance from MAPS, and more so the rigor of the methodological design of the study itself, will enable the results of the study to be viewed by skeptics as more objective. If the results of the pilot study are promising, MAPS will again explore options for the support of research at McLean Hospital. February 6, 2006. MAPS' Data Safety Monitoring Board (DSMB) met to review records for the six new subjects who have enrolled since their last meeting in Dr. Michael Mithoefer's study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. With data from a total of eleven subjects before them, the DSMB reported that they did not have any concerns about the safety of the study, and recommended that it continue without modification. The DSMB is comprised of an M.D., a Psy.D., and a Pharm.D. not otherwise involved in the study. Dr. Mithoefer has successfully treated 11 out of an eventual 20 subjects, and is currently treating the twelfth. The DSMB also reviewed and approved three protocol changes that Dr. Mithoefer and MAPS will initially submit to FDA and then, if approved, to our Institutional Review Board (IRB). Dr. Mithoefer is seeking permission to: 1) Increase the number of MDMA experimental sessions from two to three, to evaluate whether this extra session will enable subjects to make more therapeutic progress. 2) Administer supplemental doses of 1/2 the initial dose of MDMA 2 to 2 1/2 hours after the initial dose, in order to prolong the relatively short plateau of MDMA's full therapeutic effectiveness. 3) Since Dr. Mithoefer has recently renewed his Board certification in ER medicine, we have asked to do without the additional Board-certified ER doctor sitting in the next room. In comparison, Dr. Peter Oehen's study in Switzerland has been designed and approved for three MDMA experimental sessions and the use of supplemental doses. Dr. Kotler's study in Israel has been designed and approved with supplemental dosing but just two MDMA experimental sessions. January 25, 2006. An article in the New Zealand Herald about posttraumatic stress disorder (PTSD) in veterans mentions the use of MDMA for PTSD but makes some incorrect claims. A letter to the editor from Rick Doblin corrects the mistakes. This article demonstrates that there is a widely perceived need for more effective treatments for PTSD and that the MDMA research is increasingly accepted as a necessary and not very controversial effort. December 27, 2005. An article in the Washington Post, "A Political Debate On Stress Disorde," by Shankar Vedantam, reports that in 2004 the US Veterans Affairs Department spent $4.3 billion on PTSD benefit payments to a total of 215,871 veterans. If the results of the second half of our MDMA/PTSD study are as promising as the results of the first half, we will have data suggesting that it would be financially wise for the VA to fund the entire $5 million cost of MAPS' Phase III studies to evaluate whether MDMA-assisted psychotherapy for PTSD should become approved by the FDA as a legally-available treatment for PTSD.   MAPS received word from Dr. Peter Oehen, Principal Investigator of the Swiss MDMA/PTSD pilot study cosponsored by MAPS and the Swiss Association for Psycholytic Therapy, that the final written approval from the ethic committee arrived today. Dr. Oehen will now submit the protocol and the other documents to Swissmedic, for a review process that we expect will take a month or two. December 20, 2005. Dr. Michael Mithoefer, Principal Investigator of the MAPS-sponsored MDMA/PTSD psychotherapy study in Charleston, South Carolina, filed an Annual Status Report with his Institutional Review Board (IRB). There have been no drug-related Serious Adverse Events (SAEs) and the results on treatment efficacy are promising. November 15, 2005. An excellent roundtable discussion about psychedelics and Judaism was published in Jewish Currents, published by the Association for Promotion of Jewish Secularism, Inc. The article is entitled, "Just Say Maybe- Psychedelic Drugs, Healing and Politics: An Interview with Four Jewish Researchers (Rick Doblin, Charlie Grob, Julie Holland, Howard Lotsof). November 11, 2005. The Good Drugs Guide Radio show, out of England, broadcast a show entitled,"The State of Ecstasy." The show is described as follows, "It's ten years since the death of Leah Betts, a teenager who died after taking a single tablet of ecstasy, also known as MDMA. Her tragic death triggered a huge backlash against the drug here in the UK. Even so, 700,000 people still take E every week in this country. So what have we learnt about ecstasy in the last decade? Do the stories of terrible comedowns, brains like swiss cheese, and instant death have any credibility? Could MDMA really become a prescription drug? And has the music got any better? We find out. Guests include Dr Julie Holland, author of Ecstasy The Complete Guide, Rick Doblin, president of MAPS.org, and Mike Linnell of drug charity Lifeline. The show also uses clips from the excellent ABC documentary, Ecstasy Rising."   MAPS received word that the Israeli Ministry of Health has approved our MDMA/PTSD pilot study!! One condition was that the Israeli Anti-Drug Authority write a letter formally indicating support for the protocol, which the Israeli Anti-Drug Authority has done. Now we need to bring the Israeli therapeutic team to the US to observe an MDMA/PTSD session conducted by Dr. Michael and Annie Mithoefer and we need to bring MAPS Clinical Research Monitoring Team to Israel, to set up the Case Report Forms and the Standard Operating Procedures (SOPs). Plus we need to arrange to export MDMA to Israel for the study. Once these steps have all been accomplished, the study itself can begin enrolling subjects. We're anticipating that the study can begin in March 2006. November 8, 2005. Dr. Michael Mithoefer received the disappointing news that the National Institute of Mental Health (NIMH) has rejected our grant application seeking $125,000 over two years for the development of a treatment manual for the use of MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder (PTSD). MAPS' grant application was not scored (it was considered in the bottom half of all applications). This rejection isn't really surprising since the last time NIMH gave a grant for anything to do with psychedelic psychotherapy was over 30 years ago, with all NIMH intramural psychedelic psychotherapy research stopping in 1967. MAPS invested $2,768 in the NIMH grant application, but the money is not wasted. We have gained a better understanding of what it will take to complete the treatment manual that we have already begun to develop and we now can say that we have indeed tried to obtain funding from NIMH. Maybe once we complete the initial pilot study, we can submit the results to NIMH and try again to obtain support. It has been reported that in 2004, the Veterans Affairs Department (VA) spent $4.3 billion on PTSD disability payments! In 2006, the VA requested $2.2 billion for mental health services. Once we have completed our initial pilot study, we may have a better chance of obtaining some federal funding for MDMA/PTSD research. November 7, 2005. The Daily Texan, the newspaper of the University of Texas at Austin, published a letter about, "The harms of MDMA" that presented misleading information about MAPS' MDMA research projects. The letter critiqued a previous column entitled, "Debunking drug folklore," MAPS President Rick Doblin replied to correct the record. While taking time to write to a student newspaper may not at first glance represent a wise use of MAPS staff time, in the age of Google, even student letters can be read by a large number of people, especially when the topic is discussed repeatedly in the student newspaper. Indeed, the Daily Texan also published a more reasonable letter, "The harm of Ecstacy, II." While MAPS concentrates on scientific research, our educational mission is also of major importance. October 21, 2005.  An article in the UCLA Daily Bruin discusses animal rights protesters objecting to a proposed study in primates, "Making Connections: MDMA Research on the Mechanisms of Affiliation and Trust." The article mentions that this research was submitted for funding to MAPS, by Anthropology Professor Alan Page Fiske, who is quoted as saying, "The biggest problems we have in the world are people not trusting each other and not feeling a solidarity (and) feeling distant," Fiske said. "If we could understand the basis of compassion and caring, that's about the most important thing human and biological sciences could do." A MAPS Bulletin article about Prof. Fiske's research can be found here. At present, there is no funding for the study. Briefly stated, MAPS has not funded animal research for about ten years but is not categorically opposed to doing so if the research is of sufficient importance. MAPS considers Prof. Fiske's proposed research to be sufficiently important to be worthy of being conducted but the information it would generate isn't essential for MAPS' program of research intended to develop MDMA into an FDA-approved prescription medication. MAPS' top priority is our human studies into the therapeutic use of MDMA. These studies require substantial resources so our intention is to conduct further research in animals only when required by FDA. October 14, 2005. A DEA Field Investigator came to McLean Hospital to test the alarms on the safes at the Pharmacy, where the roughly 4 grams of MDMA will be stored for the MAPS-sponsored MDMA/cancer anxiety study. Everything seemed to be in order and the DEA investigator stated that his report should get processed within one month. We're cautiously optimistic we'll have the final approvals before the end of 2005. October 8, 2005. Dr.med. Peter Oehen submits an MDMA/PTSD protocol for review to a Swiss ethics committee, for a pilot study co-sponsored by MAPS and the Swiss Association for Psycholytic Therapy (SAePT). This study will involve three experimental sessions instead of two and will use supplemental dosing 2 1/2 hours after the initial dose. August 2, 2005. Ironically, after NIDA-funded researchers Drs. McCann and Ricaurte claimed that MDMA damaged dopamine neurons and could cause Parkinson's disease, a claim that they later had to retract, new research conducted at Duke University Medical Center has shown that MDMA is the most effective of 60 drugs tested in reversing the symptoms of Parkinson's disease! This research was discussed in an article in News-Medical.Net; note also a brief commentary on this and other related research into MDMA as an anti-Parkinson's disease treatment. July 22, 2005. The 10th subject had her 2nd experimental session, which went well. Once she completes her final follow-up evaluation in about two months, we will have completed half of Stage 1 of the study. We'll then conduct a preliminary data analysis and submit it to MAPS' Data Safety Monitoring Board (DSMB) for review. There have been no Serious Adverse Events (SAEs) during the first half of our study and the outcome data looks promising. Stage 2 is for those subjects who received placebo and wish to reenroll in the study to receive MDMA "open-label." The second subject in Stage 2 is scheduled to receive her second MDMA session on Monday, August 1. This session will also be used as a training session for Drs. Halpern and Naidoo from Harvard Medical School. They have the subject's permission to observe in order to help them prepare to conduct their MAPS-sponsored study of MDMA in subjects with anxiety associated with advanced-stage cancer. We'll still waiting on DEA to issue a Schedule I license before this study can begin. July 19, 2005. Australia's Herald Sun publishes "Pill poison," an article about the proliferation of of ecstasy dealing, consumption, and adulteration in the nation's most populated region. The link also includes and editorial from the Herald Sun demanding that the community take responsibility for the nation's drug problems. July 18, 2005. Austrailia's United Press runs "Dealers lacing ecstasy with other drugs," reporting on the widespread adulteration of ecstasy tablets throughout the country. July 7, 2005. The IRB approved the requested changes, conditional to accepting changes in the consent documents. Dr. Mithoefer accepted all changes the IRB recommended. Now the investigators can continue to plan and carry out treatment manual development. July 1, 2005. A letter from the National Institute of Mental Health (NIMH) arrived at MAPS today, saying that our grant application, "Treatment Manual Development for MDMA-Assisted Therapy," has been received and assigned to a Scientific Review Group (SRG). The initial peer review should be completed by the end of November 2005, with funding decisions made in January 2006 after the meeting of the appropriate National Advisory Group. MAPS' grant application can be found at: http://www.maps.org/mdma/ptsd_study/grant0605/ June 23, 2005. Michael Mithoefer submitted proposed changes to the MDMA/PTSD, including provisions for videotaping all psychotherapy sessions, a step needed for developing a treatment manual for MDMA-assisted psychotherapy in people with PTSD, as needed to carry out the work proposed in the grant application submitted to NIMH. June 17, 2005. UK News site Guardian Unlimited ran this story about Alexander Shulgin, his history as a pharmacologist, and the repercussions of his 1965 synthesis of MDMA. June 6, 2005. The study protocol for the MDMA/PTSD study to take place in Israel was reviewed and approved by the Beer Yaakov Medical Center ethics committee (IRB). The study has now been sent to the Israeli national ethics committee. If it is approved by the national ethics committe, it will then be reviewed by the Ministry of Health. May 31, 2005. Michael Mithoefer MD submitted a grant application to NIMH for developing a treatment manual of MDMA-assisted therapy for PTSD. May 23, 2005. Online Publication Nursing Spectrum puts forth an article discussing the Harvard study of MDMA psychotherapy for treatment of anxiety associated with terminal cancer. Author Lisette Hilton quotes Dr. John Halpern that "the benefits of this therapy would have greater application for nurses who tend to dying patients on a daily basis than for the physicians who prescribe the therapy."   The CQ (Congressional Quarterly) Weekly published an excellent cover story by Tim Starks, entitled "New Prescriptions for War Trauma." The article interviews Dr. Michael Mithoefer and discusses the MAPS-sponsored study of MDMA-assisted psychotherapy in the treatment of PTSD. May 19, 2005. Psychology Today offers two articles about psychedelic research constraints in the United States, one from 2005 and the other from 1994. Compare what 11 years can do! May 18, 2005. Join Together, a drug abuse prevention organization, ran a news summary regarding the recent St. Petersburg Times article on the MDMA research MAPS sponsors. May 16, 2005. Canadian newspaper Northern Life ran an article in the online "police beat" section by Jason Thompson in which Dr. Stephen Kish of the Northern Ontario School of Medicine, among others, discuss problems and potential of MDMA use. May 12, 2005. Rick Doblin appeared on Joe Scarborough's MSNBC segment yesterday. Here is a transcript as well as a video of the interview. May 11, 2005.  Dr. Meg Jordan, Global Medicine Hunter, puts out a podcast about MAPS' research into the use of MDMA in the treatment of postraumatic stress disorder (PTSD) in Iraq War vets, and about her work with the therapeutic use of MDMA in the late 1970s! May 9, 2005. The International edition of Newsweek published "A Psychedelic Cure", a piece similar to the a piece published last week in the domestic edition, but with greater discussion of proposed studies of MDMA-assisted psychotherapy in Spain and Israel..   The St. Petersburg Times ran a front page article,"Party pill gets tryout in therapy" written by Janet Zink, offering reporting on MAPS' mission of decriminizaling the use of MDMA for therapeutic purposes. May 2, 2005. Newsweek Magazine runs a story on MDMA research by Eve Conant, Ecstasy: A Possible New Role for A Banned Club Drug. April 22, 2005. Donna Leinwand, USA TODAY writes: Post-9/11 security cuts into Ecstasy. "The changing economics of Ecstasy is leading a rising number of youths to turn to cheaper, more available drugs. Among them: addictive prescription painkillers such as OxyContin and Vicodin, inhalants such as paint thinner, and methamphetamines. Two recent surveys said OxyContin and Vicodin had passed Ecstasy in popularity among teens." "And this is considered progress!" comments Rick Doblin, MAPS President. April 11, 2005. The LA Times published, "Ecstasy's Good Side", reporting on MDMA/cancer anxiety study to be conducted by John Halpern MD, and discussed related studies (such as the study of psilocybin in people wiht cancer-related anxiety conducted by Charles Grob MD, and the ongoing study of MDMA in people with PTSD. Note that the article erroneously reports on the location of the last study, which is at the offices of Michael Mithoefer MD, and not at the Medical University of South Carolina. March 25, 2005. The largest Israeli newspaper, Yediot Ahronot, published a favorable article about MAPS' Israeli conference, which took place the day before, and the use of MDMA-assisted psychotherapy in treating posttraumatic stress disorder (PTSD). The article was accompanied by an incredible graphic of a drowning man holding on to a life preserver that was actually an Ecstasy pill with a smiling face. March 24, 2005. MAPS sponsored a very successful conference in Israel on research with MDMA, ibogaine and marijuana for the Israeli Ministry of Health, the Israeli Society of Addiction Medicine, and representatives from the Israeli Anti-Drug Authority. The conference was intended to educate Israeli regulators and researchers about MAPS' proposed MDMA/PTSD pilot study that we're trying to sponsor in Israel, under the direction of Dr. Moshe Kotler, Chair, Department of Psychiatry, Tel Aviv University, Sackler School of Medicine. After the conference, Dr. Kotler said that he was ready to submit our draft protocol to the ethics committee for review. March 18, 2005. Two articles in a newspaper in Ibiza (El Mundo), "An association which supports drug research auctions off a week "of dancing" in Eivissa on the Internet", and "Eivissa's 'raves' have made this tourist destination mythic" discuss MAPS' ebay auction of, among other things, a week at a "villa in Ibiza" and report on MAPS' agenda. March 10, 2005. Today the Drug Enforcement Administration will visit Dr. John Halpern of Harvard Medical School's McLean Hospital as a routine procedure before issuing his Schedule I license. Once Dr. Halpern has received his license, the MAPS-funded study of MDMA-assisted psychotherapy for anxiety in advanced cancer patients can begin. March 8, 2005. The NPR show, To the Point, hosted by Warren Olney, discussed Dr. Michael Mithoefer's MAPS-sponsored MDMA/PTSD study and FDA's newly approved expansion of the study to include subjects with war-related PTSD. Guests include Dr. Andrew Pomeranz (PTSD therapist), Dr. Michael Mithoefer, Rick Doblin, Ph.D. and Robert Dupont, Ph.D. (first Director of the National Institute on Drug Abuse). The story runs from 23:35-50:52.   The Scientist published "Renewed Faith in Ecstasy", a brief article on the recent history and progress of MDMA research, and featuring quotes from Rick Doblin. March 4, 2005. BBC On-Line published an article describing recently published findings that ecstasy use was associated with increased self-reported symptoms of depression, but only in people who have a certain form of the serotonin transporter gene. You can also read a commentary on the paper. February 26, 2005. New Scientist published a lengthy and extensive overview of current and planned research into the medical or psychiatric benefits of psychedelic substances, including MDMA, psilocybin, LSD, ketamine and ibogaine, and covernig a wide array of MAPS-supported and Heffter Institute supported studies.. The article contains a history of medical research with psychedelics. February 23, 2005. The Boston Globe published a lengthy piece on the MDMA/cancer anxiety study that will take place at Harvard University's McLean Hospital. The piece features quotes from Halpern and from Rick Doblin.   National Public Radio (NPR)'s "All Things Considered" aired an interview of John Halpern, who spoke about the MDMA/cancer anxiety study. You can hear a recording of the interview on the NPR website or you can read the transcripts of the interview.   ABC World News Tonight briefly reported on the MDMA/cancer anxiety study to be conducted by John Halpern MD. February 17, 2005. The Guardian published an extensive discussion of current and planned research into the therapeutic uses of MDMA and psychedelic drugs. The article quotes John Halpern, Rick Doblin and Michael Mithoefer, and covers a surprising breadth of current and planned research in this area.   The Guardian published another report specifically noting the recent expansion of the MDMA/PTSD study to now accept people with combat-related PTSD. The report features quotes from Michael Mithoefer, the prinicpal investigator. This is not a "new" study specifically looking at combat stress. Rather, the ongoing study is now no longer restricted to people with crime-related PTSD.   The German newspaper Der Spiegel published a report on the recent expansion of the MDMA/PTSD study to include people with combat-related PTPSD that is even more muddled than the report from the Guardian, above. Not only does this report suggest that a new investigation is underway, but that the US military is involved in this study. As already noted, there is no new study specifically studying MDMA-assisted therapy in people with combat-related PTSD, and the military has not been involved in any step of this research so far. February 16, 2005. The January issue of the Brazilian science magazine Galileu published "Da Balada Para o Diva,", an article in Portugese by Juliana Tiraboschi about research into the potentially therapeutic uses of MDMA.. The paper discusses the MDMA/PTSD study and quotes MAPS president Rick Doblin. You can also read a PDF version of the article.   Dr. Michael Mithoefer and Annie Mithoefer were guests on Kathleen Brooks' radio show on World Talk Radio, Darkness to Light: Breaking the Conspiracy of Silence, for an hour-long discussion of their MAPS-sponsored MDMA/PTSD study. February 4, 2005. The UCLA newspaper the Daily Bruin featured a report on Charles Grob's research on psilocybin in people with cancer experiencing anxiety relating to their illness. The piece quoted Grob and Dr. John Halpern, the principal investigator of the MAPS-sponsored study of MDMA in people with cancer-related anxiety.   Today Michael and Ann Mithoefer performed the first experimental (MDMA or placebo) session for the sixth participant enrolled in the study of MDMA-assisted psychotherapy in people with PTSD. If all goes well, the next experimental session will occur in three to five weeks. January 30, 2005. January 30, 2005. The New York Times Sunday Magazine published a profile of psychedelic chemist, Sasha Shulgin, that highlighted the approval of MDMA research at Harvard sponsored by MAPS (though MAPS was not mentioned). The article includes a quote from Dr. Steve Hyman, Harvard Provost and ex-Director of the National Institute of Mental Health, saying that he is skeptical whether MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer will actually prove beneficial but that he thinks the research should go forward. The ghost of Timothy Leary has now definitely be laid to rest at Harvard. Now it's up to us to prove what we have been saying for decades, that MDMA and other psychedelics have remarkable healing potentials. As the saying goes, "Beware what you wish for." The challenge of proving the safety and efficacy of psychedelic psychotherapy is formidable, but definitely a goal worth the decades of prior and future work. January 21, 2005. Psychiatry News (a publication of the American Psychiatric Association) reported on the proposed MDMA/cancer anxiety study, with quotes from principal investigator John Halpern MD.. January 16, 2005. The Boston Globe published an article contrasting FDA approval of MAPS' study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer with DEA rejection of Prof. Lyle Craker's MAPS-sponsored application for a license to establish a facility to produce marijuana for federally-approved research.   The Week in Review section of the Sunday New York Times had a thoughtful but rather snide and inaccurate article on the research into the use of MDMA and psilocybin in the treatment of anxiety associated with advanced cancer.    Prof. Mark Kleiman criticizes a NYTimes article on the use of psychedelics in treating anxiety in subjects with advanced-stage cancer. He notes the flawed central assumption of the article which is that "all "drugs" are alike, and that "drugs" have the property of dulling perception and cognition, making people less present to what is happening to them." January 14, 2005. Dr. John Halpern submitted his application today to DEA for a Schedule I license, the final regulatory approval required before we can begin the MDMA/cancer anxiety study. Dr. Halpern has already received his State Schedule I license. January 8, 2005. Dr. John Halpern is the guest on C-SPAN's Washington Journal for a live, half-hour national call-in show focused on Dr. Halpern's MAPS-sponsored study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. January 7, 2005. The Boston Herald published a short piece describing the MDMA /cancer anxiety study, quoting primary investigator John Halpern and MAPS President Rick Doblin. January 6, 2005. MAPS donated $26,616 to McLean Hospital, Harvard University, for Dr. John Halpern's MAPS-sponsored study of the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. This represents the first payment in what we expect will total $250,000 for this study. The approval of this study by McLean Hospital (where the MDMA-assisted psychotherapy will take place), the Lahey Clinic (where the patients receive primary care for their cancer), and the FDA, represents a triumph of hope over fear, hope for the too-long obstructed promise of MDMA-assisted psychotherapy v. fear of the risks of MDMA exaggerated by anti-drug crusaders and scientists for their own ends. At a time when the US government has placed all its eggs in the fear basket (war, terrorism, "drugs", financial ruin of Social Security, gay marriage, etc., etc.), the remarkably widespread media reporting of FDA's approval of psychedelic research again at Harvard after 40 years shows that people are eager for balance, for hopeful news. It's now clear that the American public would welcome whatever help can be provided in facing directly life's final challenge, to die gracefully and in peace, even if such help comes from a previously demonized and criminalized substance also used by young people seeking pleasure. January 5, 2005. The Harvard Crimson reported on the MDMA/cancer anxiety study that will be taking place at McLean Hospital. Principal Investigator John Halpern MD is quoted, as well as MAPS President Rick Doblin PhD. The on-line version of this article has a link to a letter written by Timothy Leary and Richard Alpert (Ram Dass) and published in the Crimson in 1962. December 31, 2004. An amazing editorial, Examining Ecstasy, about FDA approval of MAPS' MDMA/cancer anxiety study, was published today in the Ottawa Citizen. MAPS' Harvard study is considered restrained and Charles Grob is chastised for speaking of potential spiritual benefits! December 30, 2004. An article in The Australian reports on the FDA approval of MAPS' MDMA/cancer anxiety study and quotes Australian Medical Association Queensland public health committee chairwoman Jeanette Tait as saying, "The medical community would look askance at this type of trial, except that it is being conducted by such a respected body," she said. "As it is such a fairly substantial body doing the trial, especially with FDA approval, I think the results will be very interesting. There's so much to be wary about illicit drugs and their use." Dr. Tait's comments reaffirm the value of MAPS' efforts to conduct MDMA psychotherapy research at Harvard, since the research is being taken more seriously as a result of where it is being conducted. December 29, 2004. Some of the most important Spanish newspapers and journals broke the news about the MDMA/cancer anxiety study, echoing the news report from the Washington Post. These reports are apparently very favorable. These include "EE UU ensaya el uso de éxtasis en enfermos de cancer terminal" (El País, December 28, PDF), "Cientficos de EE UU investigarn el uso del 'éxtasis' en enfermos terminales" (El Correo Digital, December 29, PDF) and "EEUU aprueba un estudio sobre el uso psiquitrico del 'éxtasis'" (El Mundo, December 28, PDF). December 27, 2004. Excellent Washington Post article by Rick Weiss about FDA approval of MDMA/cancer anxiety research and general renewal of research into the therapeutic potential of MDMA and psychedelic compounds. [ Also see scans of the article. ]   The AP Wire Service published a report on the recent FDA approval of the MDMA/cancer anxiety study, with quotes from principal investigator John Halpern MD. December 17, 2004. The FDA approved John Halpern's MDMA/cancer anxiety study today. November 19, 2004. A fateful step has been taken. Today, MAPS submitted Dr. John Halpern's MDMA/cancer anxiety protocol and associated documents to the FDA. FDA should receive the protocol Monday, November 22 and will then have 30 days from that point to review it. FDA will either approve the protocol or place it on clinical hold pending resolution of any issues FDA felt it appropriate to raise. If approved by FDA, the last remaining major hurdle before the study can start will be Dr. Halpern's need to obtain a DEA Schedule 1 license to dispense the MDMA to be used in the study. After FDA approval has taken place, we feel that DEA will most likely issue the license sooner rather than later, probably voluntarily. DEA cooperation will be due to the compelling nature of this study, the amount of existing interest and support, the very low risk of diversion since there are no "take-home" doses, and, most importantly, the regulatory limits on the factors that DEA can use to evaluate applications for Schedule I licenses to conduct FDA-approved research. If fully approved, this study will become the first psychedelic research to take place at Harvard since 1965. A new era will then have begun in earnest 21st Century psychedelic research! November 15, 2004. At the request of our Institutional Review Board (IRB), MAPS has established a Data Safety Monitoring Board (DSMB) that works for MAPS reviewing the data from Dr. Mithoefer's MDMA/PTSD study on an ongoing basis. The DSMB met today to review the charts from the first five subjects who have completed their final follow-up evaluation. which takes place two months after the second experimental session. The DSMB concluded that "We did not see any significant adverse events that caused us any concerns about the safety of this study." They recommended that "the study continue without modification." The next scheduled meeting of the DSMB will take place after the next five subjects (the 6th-10th) have completed their final follow-up evaluations. The DSMB will also meet if there is a serious adverse event. November 10, 2004. The Lahey Clinic Institutional Review Board (IRB) met this evening to review the MAPS-sponsored pilot study designed to explore the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer, to be directed by co-investigators Dr. John Halpern, Dr. Todd Shuster, Dr. Umadevi Naidoo, and Dr. Arthur Siegel. This protocol has to be reviewed and approved by both the IRB at McLean, where the psychotherapy and experimental sessions will take place, and by the IRB at Lahey Clinic, where Dr. Shuster works and from where the subjects will be recruited. After the protocol was introduced by Dr. Shuster, Rick Doblin, Ph.D. and Dr. Halpern responded for about 30 minutes to a series of thoughtful and important questions from members of the IRB. The protocol and second, short informed consent form (covering just the initial screening process at Lahey) were then...approved! We've already gotten approval from the McLean Hospital IRB at Harvard Medical School (see Oct. 27, 2004 entry), so now it's on to the FDA. We expect to submit the documents to FDA within the next week to ten days. FDA must, by regulation, respond in some manner within 30 days.   The McLean IRB approved the shortened informed consent form for the MAPS-sponsored pilot study designed to explore the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer. October 26, 2004.  Harvard Medical School's McLean Hospital Institutional Review Board (IRB) met to review the MAPS-sponsored pilot study designed to explore the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer, to be directed by co-investigators Dr. John Halpern, Dr. Todd Shuster, Dr. Umadevi Naidoo, and Dr. Arthur Siegel. The protocol was...approved! The only conditions were that that the approval was subject to FDA and DEA approval, and we were requested to shorten (!) the informed consent form. October 12, 2004. As a result of a FOIA request made earlier this year, MAPS now has information on National Institute on Drug Abuse (NIDA) funding awarded to Dr. George Ricaurte and Dr. Una McCann in 2003 for the study of MDMA (Ecstasy) neurotoxicity and functional consequnces of Ecstasy use. The pair of Johns Hopkins researchers were awarded over $1.8 million dollars during 2003. This brings their total government funding to more than $16.4 million since 1989. October 8, 2004. The October 8-14 Boston Phoenix features an interview with MAPS' president Rick Doblin Ph.D. that discusses, among other things, ongoing research into the therapeutic effects of MDMA, psilocybin, and marijuana. September 30, 2004. The Salt Lake City Weekly published a piece on Ecstasy & Therapy. The piece includes interviews with two therapists practicing "underground" MDMA-assisted therapy, and an interview with Rick Doblin Ph.D., president of MAPS. September 27, 2004. Wired published a piece charting the progress of research into the therapeutic uses of psychedelic drugs, including the ongoing studies of MDMA-assisted psychotherapy in people with PTSD, psilocybin in people with OCD, and psilocybin in cancer patient with anxiety, as well as planned studies into MDMA-assisted therapy in people with anxiety associated with advanced stage cancer, and psilocybin and LSD in people with cluster headaches September 14, 2004. The journal Movement Disorders has recently published two letters in response to a report of parkinsonism in a former ecstasy user, and include a reply from the authors of the case report. The two letters include a letter authored by MAPS' Lisa Jerome and Rick Doblin and MDMA/PTSD study principal investigator Michael Mithoefer, and a report of a transient dystonia appearing after Ecstasy use. In their reply to both letters, the authors acknowledge the likely rarity of movement disorders associated with Ecstasy use, but fail to discuss the lack of evidence for a relationship between Ecstasy use and movement disorders. August 20, 2004. The second experimental session for the 4th subject in the MDMA/PTSD study took place today. The session went very well. The next Data Safety Monitoring Board (DSMB) meeting will take place after the 5th subject has completed the final follow-up testing, two months after that subject's 2nd experimental session. August 16, 2004. Dr. John Halpern submitted a lengthy response to the questions that we were asked to address by the IRB reviewing the MDMA/cancer anxiety study. Now we wait until the IRB meeting at the end of August to see if there are more questions. We're feeling hopeful about an eventual resolution of all the issues. August 15, 2004.  Medicine Hope for Psychedelic Drugs, an article from BBC News (UK Web), by Arran Frood, discussed psychedelic psychotherapy research supported by Heffter Research Institute and MAPS. This article is mostly based on an interview with Dr. Charles Grob and leaves the impression that it's about time that research into the therapeutic uses of psychedelics has resumed. August 10, 2004. MAPS' Data Safety Monitoring Board (DSMB) for the MDMA/PTSD study met today to review the data on the first five subjects who participated in at least one experimental session. The DSMB was comfortable with the data, and has recommended that the study continue as designed, without any modification. August 6, 2004. . The third subject in the MDMA/PTSD study participated in the second (and final) experimental session. The experimental sessions have all been scheduled on Fridays, which is working out to be a convenient time and gives subjects the weekend to rest and reflect. August 4, 2004. The Charleston, South Carolina Post and Courier published an article about the MDMA/PTSD study. While the article overemphasizes the supposed dangers of MDMA, it does at least give the impression that MDMA may indeed have therapeutic potential. Dr. Mithoefer has written a letter to the editor clarifying some misleading statements made in the Post and Courier article. The Post and Courier also published another article on the history of psychedelic research. On August 8, the Post and Courier printed the following correction: "A story on Page 1A of Wednesday's editions of The Post and Courier incorrectly stated that Dr. Michael C. Mithoefer was administering Ecstasy to "patients." The story should have made it clear that the drug was being given to research subjects. The federally approved research program is unrelated to Mithoefer's private practice and patients. Dr. Mithoefer also notes that the story would have more appropriately drawn a distinction between dangerous recreational use of Ecstasy and controlled clinical studies if it had noted other studies, including three US studies approved by the FDA, that found "no serious adverse events" and "no evidence of neurotoxicity" in tests administered under medical supervision." July 28, 2004. The McLean IRB meet on Wednesday to review the MDMA/cancer anxiety study. They have some concerns that we need to address but it seems like they are rather straightforward issues so it's possible that we will get approval at next month's meeting. If so, then we will start seeking the rest of the approvals (from an IRB at the Lahey clinic where the oncologist works and where the subjects will come from, FDA and DEA). July 25, 2004. A front page article in the Sunday Baltimore Sun discussed MAPS' MDMA psychotherapy research in a favorable light, illustrated with a photo of Rick Doblin. Of special note is the conclusion, in which Dr. George Ricaurte says that MDMA may one day find a place as an accepted medication. On July 29, the Sun published a clarification to the article. July 21, 2004.  Dr. John Halpern has integrated preliminary comments from the McLean IRB and submitted revised versions of a protocol, informed consent, treatment manual, and the most recent update of the MDMA literature review (January 2003-March 2004) for his MAPS-sponsored proposed study of MDMA-assisted psychotherapy in subjects with anxiety related to advanced-stage cancer. July 9, 2004. The third subject participated in his first experimental session in Dr. Mithoefers' MAPS-sponsored MDMA/PTSD study, without any adverse side effects. Several additional subjects are also scheduled to participate in their first experimental sessions during this month. July 6, 2004. MAPS' effort to start research at Harvard into the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer began a new phase today, as Dr. John Halpern submitted a draft of the protocol to the McLean Hospital Institutional Review Board (IRB) for preliminary review. We anticipate several months of review and discussion before we will be able to determine if the protocol will be accepted. If so, the study then moves to the Lahey Clinic IRB for further review (Dr. Todd Shuster, oncologist co-investigator, works at Lahey Clinic and will refer subjects to participate in the study), and then on to the FDA. We're hoping that this study will be the vehicle to restart psychedelic research at Harvard again, for the first time since 1965! June 28, 2004. Dr. John Halpern of Harvard Medical School's McLean Hospital submitted a protocol for review to the McLean Institutional Review Board (IRB) for a MAPS-sponsored study of MDMA in the treatment of anxiety in advanced stage cancer patients. After years of laying the groundwork for this study, and months of protocol development, we have now formally begun the effort to open a new area of research for MDMA and to restart psychedelic research at Harvard for the first time since 1965. If the McLean IRB approves the study, the protocol will then go to the IRB at Lahey Clinic, where oncologist and co-investigator Dr. Todd Shuster works and from where the subjects will be referred into the study, and then on to FDA. We anticipate that this study will take three to six months to become fully approved and hope to start treating the first subjects in late 2004 or early 2005. Before MDMA was criminalized in 1985, several psychiatrists and therapists worked with cancer patients with MDMA with positive results in terms of reduced anxiety and pain. In the 1960s and early 1970s, LSD was also used successfully in the psychotherapeutic treatment of cancer patients. MAPS work to resume this line of research at Harvard represents an extremely important effort to start a new era of psychedelic research, at a culturally symbolic place where many people think psychedelic research went off the track, evidenced by Timothy Leary and Richard Alpert (Ram Dass) being kicked out of Harvard in 1963. After almost 40 years in the proverbial wilderness, its time for psychedelic research to return to Harvard! May 14, 2004. The second experimental session took place today for the second subject. (Due to scheduling complications, the first subject's second session is scheduled for next week.) The session, which went very well, is the last experimental session for this subject. She will receive some additional non-drug psychotherapy and a final follow-up evaluation two months from now. May 13, 2004. Nature publishes a lengthy article and editorial about MDMA psychotherapy research. The articles, about which Rick Doblin has written a lengthy commentary, are supportive of MAPS' research efforts. Alex Gamma wrote a letter to the editor responding to claims of insufficient knowledge of extent of risks in human trials made in the piece and providing greater detail on a human trial of MDMA described in the article. May 3, 2004. Rick Doblin met in Jerusalem with Dr. Miki Reiter, Israeli Ministry of Health, about MAPS' proposed Israeli MDMA/PTSD pilot study in subjects with war and terrorism-related PTSD. Dr. Reiter is supportive of the project and welcomed MAPS offer to donate $75,000 to fund the pilot study. May 2, 2004. An Israeli dentist who survived a suicide bombing in a Jerusalem cafe in March 2002 that killed about 11 people met in person with Rick Doblin in Jerusalem. The dentist contacted MAPS last week after searching the internet for pages about MDMA and PTSD. The dentist, who has permanent hearing loss but wasn't otherwise seriously wounded, developed PTSD after the bombing. After treatment with psychotherapy and SSRIs that was only moderately helpful, he discovered on his own that MDMA was of major benefit to him. He contacted MAPS since he felt it was a shame that MDMA had been available to him only illicitly and at risk to his professional license. After a long discussion, he surprised Rick by mentioning that the place he had chosen for their meeting was the same cafe in which the bombing had taken place. He has written a report, which is followed by additional comments from Rick. April 30, 2004. Rick Doblin met in New York City with Israeli psychiatrist Dr. Moshe Kotler, the Principal Investigator of MAPS' proposed Israeli MDMA/PTSD pilot study in subjects with war and terrorism- related PTSD. Now that the US study is fully approved, Dr. Kotler feels the time is right to move forward with the protocol design and approval process for the Israeli pilot study. Dr. Kotler used to be the chief psychiatrist for the Israeli Defense Forces (IDF). April 23, 2004. The second subject participated in her first experimental session (MDMA or placebo). Each subject will receive two experimental sessions, two to three weeks apart, in additional to about 8 non-drug psychotherapy sessions. This study is now well underway and is moving forward steadily. April 19, 2004. This is the 61st anniversary of the world's first planned LSD experience. On Monday, April 19, 1943, at 4:20 PM, Albert Hofmann ingested 250 micrograms of LSD and neither he nor the world was ever the same again. Albert was trying to determine if an odd experience he had on Friday, April 16, 1943, was related to the LSD that he was synthesizing. Turns out, it was! April 16, 2004. Historic Days! The first experimental session in MAPS' MDMA/PTSD study took place today. Both the subject and the experimental team guessed that the substance that was administered was MDMA instead of the placebo. In any case, the session was remarkably therapeutic and seemed to represent a breakthrough for the subject. Sixty-one years ago, on April 16, 1943, the world's first LSD experience took place due Dr. Albert Hofmann's accidental ingestion of some of the chemical that he was synthesizing. The date of the first experimental session in the MDMA/PTSD study was set several weeks ago. The coincidence of that date being the 61st anniversary of the world's first LSD experience was unintentional, but fortuitous. September 24, 2002. John Mendelson, M.D., Associate Professor at University California San Francisco, commented on Michael Mithoefer, M.D.s proposed MDMA study. Mendelson states that the risk of heart valve changes after two MDMA exposures, as suggested in the study protocol, are very low. April 9, 2004. MAPS issues a report based on documents obtained through Freedom of Information Act (FOIA) requests showing that from 1989-2002, Drs. Ricaurte and McCann received federal grants totaling over $14.6 million dollars for MDMA and MDMA-related research. (A FOIA request for 2003 data has been submitted.) This is a rather amazing amount of money and suggests that Drs. Ricaurte and McCann had some powerful incentives to exaggerate the risks of MDMA. This also speaks volumes about our society’s warped priorities in that not a single penny of federal money has been awarded to explore any of the therapeutic uses of MDMA. This is an imbalance that MAPS hopes to rectify over the coming years. April 6, 2004. In an article in Talon News (bringing the conservative message to America), the fundamentalist drug warrior, Rep, Mark Souder, Chairman of the House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources and author of the infamous law that denies educational loans to students with a prior drug conviction, has strongly criticized Peter Jennings’s Ecstasy Rising documentary. Rep. Souder’s criticisms of Peter Jennings’ "lack of a moral compass" demonstrate yet again that the Drug War is a holy, moral crusade where facts are subjugated to ideology.   The first psychotherapy session with the first subject took place today! In addition, a second subject passed the screening process and has qualified for the study. This study is definitely underway, full speed ahead. April 5, 2004. Video archives of the Peter Jennings special, Ecstasy Rising, are now available.   Comments from Erowid April 1, 2004. Ecstasy Rising. Federal Campaign to Curb Club Drug Use Hasn’t Dimmed Its Popularity, ABCNEWS.   Club Drug Tested as Treatment for Post-Traumatic Stress Disorder By Bob Woodruff, ABCNEWS.   Here are Mark Kleiman’s comments on the ABC TV documentary. March 30, 2004. A new study of MDMA self-administration in monkeys found MDMA to be far less toxic than assumed from previous studies. Study findings suggest that when monkeys take doses of MDMA similar to those used by Ecstasy-using humans, there are no signs of harm to serotonin or dopamine cells. Study findings also suggest that monkeys, like humans, may slowly lose interest in taking MDMA over time, and that this change of heart is not a sign of brain toxicity. March 24, 2004. A DEA-licensed pharmacist, a Randomization Monitor, and Dr. Mithoefer are creating the MDMA and placebo capsules today for use in the MDMA/PTSD study. The process is being filmed by a camera crew from ABC for use in a feature story about the MDMA/PTSD study to be aired on World News Tonight at 6:30PM EST on April 1. Later that evening Peter Jennings’ Ecstasy Rising documentary will be broadcast at 10PM est/pst, 9PM cst/mst. March 16, 2004. IRB approval was extended another six months, to September 15, 2004, or until the first Data Safety Monitoring Board (DSMB) report is available. Approval is conditional upon review of the data on an ongoing basis by the DSMB. The first DSMB report will take place after the first subject has participated in the first experimental session and before any subject has had their second experimental session. This first DSMB meeting will most likely take place in late April or early May. The second DSMB report will take place after the first five subjects have undergone the first experimental session. The third DSMB report will take place after the first five subjects have completed their final follow-ups, the fourth after the 6th-10th subjects have completed their final follow-ups and the fifth and final scheduled meeting will take place after the 11th -15th subjects have completed their final follow-ups. Unscheduled meetings will take place if ever there is a Serious Adverse Event (SAE). March 12, 2004. MDMA arrives! Today the tiny amount of MDMA required for the MDMA/PTSD study (4 grams) arrived, shipped with all the appropriate DEA forms and procedures. Patients are being scheduled for screening to see if they meet the inclusion and exclusion criteria. This study is now fully underway. The tentative date for the first experimental session is April 16, completely coincidentally the same date that, in 1943, Albert Hofmann first accidentally discovered the psychedelic properties of LSD. March 10, 2004. The Ecstasy Factor - Bad Science Slandered a Generation’s Favorite Drug. Now a New Study Aims to Undo the Damage, by Carla Spartos, Village Voice. This is a strong, hard-hiting article. March 4, 2004. Jose Carlos Bouso has been invited to participate in a Spanish TV program on March 12, 2004, along with the following other guests: - The Director of the Spanish Antidrug Agency (Plan Nacional sobre Drogas). - The Director of the Madrid Antidrug Agency. - The President of the Help Against Drug Addiction Foundation (FAD, Fundacion de Ayuda Contra la Drogadiccion), the most important private organization "against" drugs in Spain. - One famous Spanish sociologist expert in drug abuse. Jose Carlos has an excellent opportunity to raise the issue of the willingness of supporters of the Drug War to suppress science and ignore the welfare of PTSD patients in order to support Drug War propaganda. March 2, 2004. DEA Approves Trial Use Of Ecstasy in Trauma Cases, Rick Weiss, The Washington Post  also see comments on and corrections to the WP article by Ilsa Jerome, PhD and Rick Doblin, PhD.  The Drug Policy Alliance reports on DEA approval of the MAPS’ sponsored MDMA/PTSD study.   DEA Accedes to Ecstasy Test by Kristen Philipkoski, Wired News. This article contains a remarkable quote from George Ricaurte giving qualified support for the MDMA/PTSD study. March 1, 2004. The Israeli newspaper, Maariv, published an article about the approval of the MDMA/PTSD study, entitled "United States Approves Ecstasy to Treat Trauma: The FDA says the party drug will be used to treat people who have been sexually assaulted" by Alex Doron. February 26, 2004. One of most important national Spanish newspapers (El Mundo) published an article regarding the final approval of the US MDMA/PTSD study in its Science section. The article is quite favorable and also tells that the MAPS-sponsored Spanish MDMA/PTSD study was shutdown for political reasons. We will continue to struggle to reopen the Spanish MDMA/PTSD study.   CNN Show: American Morning, 7 AM. Dr. Drew Pinsky thinking too reductionistically_ about the use of MDMA for the treatment of PTSD, "...it’s quite legitimate...I think the idea that it creates a psychological effect may be somewhat naive, the idea that somehow people are more open to looking at the narrative around their trauma because of the sort of subjective effects of the drug, that, to me, is kind of naive because it’s so biologically powerful. It’s almost like looking at electric shock therapy again." February 25, 2004. Rick Doblin was the guest in a live email chat on the Chronicle for Higher Education website. To read the exchanges, see the transcript.  CNN announces that Ecstasy is Approved for Medical Study.  Corrections and comments on the CNN announcement by Ilsa Jerome, Ph.D and Rick Doblin, Ph.D.  Watch the CNN announcement (RealPlayer is required) 56k modem version Broadband cable/dsl version February 24, 2004. The DEA issued Dr. Mithoefer a Schedule 1 license. The first MDMA-assisted psychotherapy research project since MDMA was criminalized in 1985 now has the necessary regulatory approval from the FDA, the IRB and the DEA and can proceed. February 23, 2004. MAPS donated $11,000 to McLean Hospital, Harvard Medical School, for Dr. Halpern’s work on the protocol design and approval process for a study of MDMA-assisted psychotherapy in subjects with anxiety as a result of end-stage cancer, with outcome measures to evaluate anxiety, pain and quality of life. MAPS has previously donated $15,000 to McLean for this study on June 2003. We plan to submit the protocol to the McLean IRB before the end of Summer 2004.  Ecstasy Agonistes A retracted study on a controversial substance raises questions about the reliability of government-sponsored research on drugs, By Thomas Bartlett, Chronicle of Higher Education The Chronicle of Higher Education’s February 25, 2004 colloquy live email chat with Rick Doblin is available in the Chronicle archive. February 18, 2004. Inching closer! Dr. Mithoefer spoke with Dr. Belinda Hayes at DEA headquarters. She indicated that DEA has received a fax of the document they need from FDA but not the hard copy which they need to issue the license. She says the person at FDA claimed to have mailed it 2 weeks ago. She said it should only be a matter of days once they get the document before they get it "entered into the system" and then issue the license. January 27, 2004. Dr. Mithoefer received a call from DEA indicating they have not received the official reply from FDA yet in response to their request for a consultation. However, they know that FDA recommended that he be given a Schedule I license and as soon as DEA receives the official reply, they "will be issuing" his Schedule I license. This is the first time we have heard from the DEA that Dr. Mithoefer will receive his license and the study will be able to move forward. January 26, 2004. NIDA responds to MAPS’ FOIA request for documents about Dr. Ricaurte’s MDMA research. Three documents were sent: NIDA’s cover letter, Ricaurte’s July 15, 2003 Progress Report to NIDA Ricaurte’s October 10, 2003 letter to NIDA Read comments on these documents by Rick Doblin. January 16, 2004. Rick Doblin has written a paper discussing how the risks of MDMA neurotoxicity have been exaggerated by government officials and government-funded scientists in a manner that has been used to support prohibitionist policies.  Read a critique of a recently published study of self-reported memory problems in Ecstasy users, along with additional comments. You can also view the full text of the report in PDF format. January 15, 2004. MAPS received a call from FDA reporting that DEA’s request for a consultation about Dr. Mithoefer’s qualifications to conduct research has finally arrived at FDA. Furthermore, FDA’s recommendation has already been sent back to DEA. We are inching ever closer. According to the Code of Federal Regulations [section 304(a) of the Act (21 U.S.C. 824(a))], DEA must issue Schedule I licenses to researchers with FDA-approved protocols within 10 days of DEA receiving a recommendation from FDA that an applicant is qualified to do the research, unless the applicant can be denied on any of the grounds specified in section 304 (a) and has either 1) lied on the application, 2) been convicted of a drug felony, or 3) no longer has State registration to administer controlled substances. Since none of these criteria apply, we may be quite close to being able to start this study. However, there could be some delays caused by the uncertain amount of time between when FDA sends its recommendation to DEA and when DEA acknowledges receiving it, with interagency mail notoriously slow. MAPS will now work to expedite this process however we are able. January 14, 2004. Dr. Michael Mithoefer has been flown to New York City and is being interviewed today for the upcoming prime-time Ecstasy documentary being created by Peter Jennings’ documentary team. We’re encouraged that a large national audience will learn of our efforts to conduct MDMA psychotherapy research. The documentary will probably be aired in late February or March. January 13, 2004. We’re still waiting on DEA to issue Dr. Mithoefer his Schedule I license. DEA claims it is waiting to hear from FDA regarding a requested consultation about Dr. Mithoefer’s qualifications to conduct research. We’ve inquired at FDA to determine whether DEA’s request for consultation has actually arrived yet and, if so, when FDA will reply. We expect to hear back from FDA shortly. According to the Code of Federal Regulations, DEA must issue a Schedule I license for FDA-approved research within 10 days of receiving favorable recommendation from FDA unless the applicant has lied on his application, has had a drug-related felony conviction, or no longer licensed by the State. Since Dr. Mithoefer cannot be refused his license on any of these grounds, we’re cautiously optimistic we will be able to start the study shortly after FDA responds to DEA’s request for consultation. January 7, 2004. FDA acknowledges receiving the FOIA request and says it will respond as soon as possible. January 6, 2004. MAPS submits a Freedom of Information Act (FOIA) request to FDA seeking copies of all correspondence between FDA and either the DEA, the Office of National Drug Control Policy, or the Partnership for a Drug-Free America, regarding the MDMA/PTSD protocol. We’d like to see what, if anything, these organizations have been communicating to FDA regarding this study. December 17, 2003. Dr. Mithoefer learned today that on December 11, 2003, the South Carolina DEA office submitted its recommendation to DEA headquarters that it give Dr. Mithoefer his Schedule I license for the MDMA/PTSD study. DEA headquarters told Dr. Mithoefer last week that it is still waiting to receive a recommendation from FDA’s Controlled Substances Staff but we have no information as to whether the FDA has actually received DEA’s request for a consultation. Step by step we move closer to starting.... December 7, 2003. A recent media report appeared, making some unduly alarming claims about MDMA and "DNA mutations." However, the claims turn out to be false. Read a commentary on the research and what it actually meant. You can also read the full text (PDF) of the original research report. December 5, 2003. Newsweek Online publishes an interview with psychiatrist Julie Holland on the psychotherapeutic use of MDMA. December 3, 2003. THE AGONY OF ECSTASY RESEARCH: Science Gets Recruited in the Drug War, by Ronald Bailey. Reason Magazine Online. December 2, 2003. Research on Ecstasy Is Clouded by Errors - The New York Times, by Donald G. McNeil Jr.  Rick Doblin, President of MAPS, published these comments on the NYT article.  The Drug Policy Alliance have issued this related press release today.  Mark Kleiman’s weblog, "An Ouchie for George" November 28, 2003. The politics of rEsearch by Harry Shapiro, is published in the Nov/Dec issue of the British magazine, Druglink. This article reports that Ricaurte’s mislabeling error "came to light when a student attempted to replicate the study and then made an official complaint when permission to publish the new findings was denied." In order to verify if this was accurate, Rick Doblin called the Johns Hopkins press office and was informed that Dr. Ricaurte says that there is no substance whatsoever to this allegation. November 26, 2003. MAPS sent a letter today to NIDA Director Nora Volkow, Ph.D., responding to a November 18, 2003 letter from Dr. Volkow to Rick Doblin. This exchange of letters was part of a package of material that MAPS sent today to members of NIDA’s National Advisory Council on Drug Abuse (NACDA) requesting that NACDA recommend to NIDA that it release information about the MDMA research of Dr. Ricaurte. Dr. Volkow indicated in her thoughtful but careful letter that she didn’t think it was necessary for NIDA to proactively release the information about the MDMA research of Dr. Ricaurte that MAPS requested and noted that MAPS will obtain some information as a result of its Freedom of Information Act (FOIA) request. In reply, Rick Doblin noted that, " NIDA should be forthcoming with the information requested. To do otherwise leaves the impression that NIDA is not actively and aggressively trying to clear up this disturbing episode that has damaged the credibility of NIDA’s educational efforts regarding the risks of MDMA and other illegal drugs." November 24, 2003. The British newspaper The Guardian published a positive article today about MAPS’ progress towards final approval of our MDMA/PTSD study. Later today, BBC Scotland will interview me about the MDMA/PTSD study during its drive-time rush hour show. BBC World News just called about doing an interview that it will send out tonight to stations all over the place, and BBC London called for its Five Live national show. Also, the youth station in Dublin, Ireland (Spin1038) will conduct an interview. Just the struggle to obtain permission for the study is presenting us with some good opportunities to do public education about MDMA.  The BBC published this news article today on its highly regarded website. November 21, 2003. Editorial published in Movement Disorders by Stephen Kish, Ph.D., "What is the Evidence that Ecstasy (MDMA) Can Cause Parkinson’s Disease?" This strong editorial examines the evidence that ecstasy can cause Parkinson’s and suggests that the evidence is very weak. It also critiques the flawed McCann/Ricaurte PET evidence that MDMA causes substantial reductions in serotonin transporter. Full text of Editorial in PDF Format November 18, 2003. Letter from Dr. Volkow to Rick Doblin. November 15-17, 2003. MAPS’ MDMA/PTSD research team met in Charleston, South Carolina to review the forms and procedures that will be used to conduct the study. The meeting went extremely well. Amy and Todd, the clinical research monitors who are volunteering to help us implement pharmaceutical-level monitoring and checks and balances, were impressively professional. This study will be conducted with a level of formality and oversight that MAPS is implementing for the first time but that will become standard on all our MDMA research projects. November 12, 2003. Dr. Mithoefer receives his Schedule I research registration (R1) from South Carolina’s Department of Health and Environmental Control (DHEC). Dr. Mithoefer is still waiting on his DEA Schedule I license, which is all we need to get started with the study. November 10, 2003. RTI denies it made mistake that torpedoed results of a $1.3M study. Triangle Business Journal, by Leo John. October 28, 2003. DEA Inspection goes very well. Several DEA agents inspected Dr. Mithoefer’s facility today as part of DEA’s review of his application for a Schedule I license to handle the 3.5 grams of MDMA needed for the entire study. The inspectors focused on issues of diversion control and checked out the safe, the alarm system and the forms and procedures that will be used to track all of the MDMA and placebo capsules. The DEA agents were interested in helping Dr. Mithoefer understand and follow their rules and were quite reasonable. Dr. Mithoefer was told he will probably receive his license in several weeks to several months. October 23, 2003. Protocol Improvements Recommended by IRBs. Though MAPS’ long series of interactions with multiple IRBs was often frustrating, several improvements have been incorporated into the protocol design as a result of recommendations/requirements made by various of the IRBs. MAPS has prepared a document listing these improvements, with the primary ones consisting of having patients remain overnight in the treatment facility which will be staffed by an RN, having data periodically reviewed by an independent Data Safety Monitoring Board (DSMB), requiring subjects to take a quiz after reading the informed consent form to make sure the primary risks were understood, and requiring a minimum score on the questionnaire assessing the severity of PTSD that reflects a "moderate" severity. October 20, 2003 MAPS sends a letter to all members of the National Institute on Drug Abuse’s National Advisory Council on Drug Abuse, requesting that it recommend that NIDA release all the information about Dr. Ricaurte’s research that MAPS has requested in its Freedom of Information Act (FOIA) request. (also in Word format) October 17, 2003. Promising news from DEA. DEA has now scheduled an inspection of Dr. Mithoefer’s facility on October 28, by agents from both the regional DEA office and the South Carolina Bureau of Drug Control. This is a routine step in the processing of a Schedule I license. It’s encouraging to see that DEA is finally moving forward with its responsibilities, now that IRB approval for the protocol has been obtained. October 14, 2003. An article by Kelly Morris, entitled Concern over research reawakens ecstasy neurotoxicity debate is published in the journal Lancet: Neurology Vol 2, November 2003 October 9, 2003. Nature publishes a short news story (PDF and HTML) on the MAPS sponsored MDMA/PTSD study. Nature 425, 552 (09 October 2003) MAPS has a few comments on the article. October 8, 2003. Could MDMA help people with Parkinson’s disease ? A recently published study in marmosets suggests that MDMA can reduce side effects of some medicatios used in the treatment of PD. October 2, 2003. MAPS responds to Ricaurte et al.’s retraction letter. MAPS addresses the evidence that Ricaurte et al. cite in their retraction letter in which they fail to give up the ghost and make a feeble attempt to claim that MDMA could, after all, actually cause dopaminergic neurotoxicity and Parkinson’s Disease. October 1, 2003. MAPS Submits FOIA Request to NIDA. MAPS receives a confirmation letter from NIDA’s Freedom of Information Act (FOIA) staff that it has received our request for specific information about the studies that Drs. Ricaurte et al. conducted with genuine MDMA that failed to find dopaminergic neurotoxicity, and about the studies that were conducted with the mislabeled bottles of MDMA and methamphetamine. The letter seems to indicate that there is a good chance that NIDA will release most or all of the information we requested, but that remains to be seen. September 23, 2003. Triumph. The Institutional Review Board (IRB) reviewing Dr. Mithoefer’s MDMA/PTSD protocol made its final decision -- and approved the study! This is a historic moment for MAPS and for MDMA research. The approval marks the end of a three-month process with this IRB, and a 22-month IRB process overall. Dr. Mithoefer and MAPS have been struggling to obtain IRB approval since November 2001, when the FDA approved the study. This is the eighth IRB to which we’ve tried to submit the protocol. Five refused to accept it for review (after varying periods of consideration), one approved it then revoked that approval for political reasons, and another finally tabled the review, after spending months formally reviewing the study before making it clear, through unreasonable demands, that the committee did not want to approve it. Along the way, we also established a MAPS IRB, but fortunately, we didn’t need to use it. The last remaining step before we can begin the study is for Dr. Mithoefer to obtain a DEA Schedule I license. DEA received Dr. Mithoefer’s application more than 15 months ago. We hope to receive a license somewhat quickly now that IRB approval has been obtained, but you can never tell with DEA. After Dr. Mithoefer does obtain a Schedule I license, we can finally begin the study of MDMA-assisted psychotherapy in subjects with chronic Posttraumatic Stress Disorder (PTSD). September 18, 2003. MAPS sends a letter to NIDA Director Nora Volkow noting the many unanswered questions in the Ricaurte et al. retraction and requesting the release of additional information. MAPS states that the credibility of NIDA is at stake. These sentiments are also expressed in a powerful editorial just released by the scientific journal, Nature. September 6, 2003. Amazing Retraction! Dr. George Ricaurte retracted his paper published in Science on Sept. 27, 2002. He originally claimed that MDMA caused severe dopaminergic neurotoxicity in primates injected with a common recreational dose regimen of MDMA, and suggested that Ecstasy users could develop Parkinson’s. Dr. Ricaurte now reports that his research team administered methamphetamine instead of MDMA to his monkeys, a mistake which came to light after he failed to replicate his findings after the oral administration of MDMA of even higher doses of MDMA to additional monkeys. Dr. Ricaurte’s claims were challenged by MAPS in an exchange of letters in Science in June 6, 2003. Those letters, and a series of media articles about today’s retraction can be found here. September 5, 2003. George Ricaurte, Ph.D.’s retraction of his paper "Severe dopaminergic neurotoxicity in primates after a common recreational dose regimen of methylenedioxymethamphetamine (MDMA)" is published in Science August 25, 2003. For the last several months, another independent Institutional Review Board (IRB) has been reviewing Dr. Michael Mithoefer’s MAPS -sponsored MDMA/PTSD protocol. Today, we submitted our response to another series of questions and a revised protocol and informed consent form. We anticipate hearing from the IRB in several weeks. MAPS had considered forming its own IRB and had written a set of required standard operating procedures and obtained commitments from a group of illustrious people to serve on the MAPS IRB. However, before launching the MAPS IRB, we decided to try one more time with an Independent IRB. So far, this IRB has restored our faith in the IRB review process since the review is being based on the scientific merits of the design. If MAPS does obtain IRB approval, the final step in the approval process will be for Dr. Mithoefer, the Principal Investigator, to obtain a DEA Schedule I license to handle a total of 3 grams of MDMA for administration to all the subjects in the study (12 subjects will each receive a dose of 125 mgs on two occasions, three to five weeks apart, with another 8 subjects will receive placebo on two occasions, also three to five weeks apart). While DEA has held up Dr. Mithoefer’s application for a Schedule I license for MDMA for over a year, and has previously indicated that it might refuse to approve Dr. Mithoefer’s license on the grounds that it considered the study not to be in the public interest, we have more recently gotten the impression that DEA will indeed approve the license once IRB approval for the protocol has been obtained. A legal analysis submitted to DEA by MAPS President Rick Doblin has been helpful in that it showed that the Controlled Substances Act (CSA) was written by a Congress that was suspicious the DEA would seek to block medical research into Schedule I drugs, which has indeed turned out to be the case. Fortunately, the CSA does not permit the DEA to take the vague category of public interest into account when it reviews applications for Schedule I licenses for FDA-approved research but is restricted to using a much more limited set of criteria relating exclusively to whether the physician can be trusted to administer the drugs to the research subjects and not divert any to non-medical uses. While nothing can be predicted with certainty, it seems that MAPS’ 17-year struggle to start MDMA psychotherapy research (MAPS was founded in 1986) may finally be successful within the next several months. Time will tell... June 19, 2003. Drs. Mithoefer, Jerome and Doblin have written a reply to the Ricaurte et al. letter published in Science on June 6, 2003. We have submitted our reply to Drs. Ricaurte and McCann and indicated that we would be happy to post their response to the MAPS website if they want to continue this debate. Read more. June 9, 2003. MAPS donated $15,046.25 to McLean Hospital, affiliated with Harvard Medical School. The donation is to enable Dr. John Halpern to develop a protocol for the use of MDMA-assisted psychotherapy in the treatment of anxiety and depression in end-stage cancer patients, and for work related to obtaining approval for the study from the McLean Institutional Review Board (IRB) and the FDA. The donation will support a portion of Dr. Halpern’s time from now until the end of December 2003. If this project is approved, it will represent the first psychedelic research at Harvard since 1965 and will signal the beginning of the post-Leary era. June 6, 2003. Letters in Science. An exchange of letters about MDMA dopaminergic neurotoxicity between the MAPS MDMA/PTSD team and the NIDA-funded research team of Ricaurte et al. appeared in the journal Science, June 6, 2003, Vol. 300, p. 1503-4. MAPS has already submitted to Science a request for a correction to a misleading statement in the Ricaurte et al. letter, in which only one of the primates was claimed to have died from the doses of MDMA administered, as compared to two primates reported to have died in the initial paper. For details, see MAPS’ discussion of the Ricaurte et al. study. MAPS is in the process of preparing a response to the Ricaurte et al. letter for the MAPS website and Forum. In brief, Ricaurte et al. state that dopaminergic deficits will only be found in binge users, but then discount all the studies in heavy MDMA users that found no dopaminergic changes by saying that they contained no or only a few binge users. This raises the obvious question of just how "common" is this binge use pattern, since they allege in the title of their paper that the doses they administered to the primates represented a "common recreational dose regimen." Ricaurte conclude their letter by saying that "we remain of the opinion that there are not sufficient data to conclude that clinical MDMA research can be conducted without running the risk of monoaminergic brain neural injury." First, it’s impossible to ever prove that there is no risk. Nevertheless, by Ricaurte et al.’s own admission that binge use isn’t even the same as heavy use, it is possible to conclude that there is no evidence that the clinical use of MDMA will in any way cause dopaminergic neurotoxicity or lead to Parkinson’s. Note also that Ricaurte et al. conclude with a general statement about both serotonergic and dopaminergic risk, and dismiss as being unpublished evidence from Dr. Franz Vollenweider’s PET scan study that showed no evidence of serotonin changes in MDMA-naive subjects administered doses of MDMA in the therapeutic range. April 11, 2003. Yet Another Dead End. The new IRB informed MAPS today that it has decided not to accept the protocol for review. MAPS was clearly told in writing a month ago that this IRB would accept the protocol for review. Now, after we spent all the staff time to prepare and submit the necessary documents and yet another month has gone by, that decision is reversed. We were told that the IRB believes that "the local IRB has to take responsibility." However, there is no local IRB, since the project is not affiliated with any local institution. A fear of liability was also mentioned. This is also rather puzzling since MAPS has been able to arrange for an insurance policy for several million dollars that would indemnify the IRB from lawsuits, in the extremely unlikely event that a subject in the study would choose to sue the IRB. Proposing to research a potentially beneficial use of one of the most demonized drugs in America, and around the world, could be considered a fool’s mission. But it’s not, it’s just extraordinarily difficult and extraordinarily important. After all, MDMA-assisted psychotherapy really can promote healing in a unique manner unlike any other prescription medicine. A moment of despair is now in order, after which MAPS will select a new strategy for moving forward with this project. March 7, 2003. Yet Another New Start. A new IRB has reviewed the documents from the first two IRBs that led to dead-ends and agreed to review the protocol. Documents were submitted, with feedback expected in a month or so. March 6, 2003. A Decision to Let the Review Stay Tabled. Two weeks have passed without MAPS receiving an estimate for the costs of consultants from the IRC-IRB. In any case, MAPS has decided to let the review remain tabled, not to pay for consultants, and start over with another IRB. We didn’t immediately inform the IRC-IRB since we expected to hear any day about the costs of the consultants, at which time we planned to explain our decision. The proverbial straw that broke the camels back was that the IRB indicated that even though a majority of its members agreed that MAPS has offered persuasive arguments against the use of a CRO and the multi-site design, the panel will not withdraw those suggestions unless and until an unanimous decision is reached after a report from consultants on seemingly unrelated matters. After waiting until March 25 without being informed of the costs of the consultants, over a month after MAPS requested in writing that these costs be provided, MAPS sent a letter to the IRC-IRB saying that we were withdrawing the application. MAPS then learned that the staff person at the IRC-IRB with whom MAPS has primarily interacted has left the IRC-IRB for reasons unrelated to our protocol. March 3, 2003. No Decision Unless Unanimous, and After Consultation. The IRC-IRB sends a letter indicating that it needs to receive the advice of consultants before making a decision on the issues of the CRO and the multi-site study. While the IRC-IRB does indicate that a majority of the members of the panel find MAPS’ arguments that a CRO is not needed to be "compelling" and that a majority are willing to consider abandoning the request for a multi-site study, we are told that no decision will be made unless it is unanimous, which MAPS is claimed to have previously agreed to though this was never mentioned before and is not standard practice. February 25, 2003. A Request for A Decision. MAPS phones the IRC-IRB and requests that the panel make a definite decision on whether it would require MAPS to hire a CRO and/or move to a multi-site design, neither of which MAPS is willing to do, before MAPS decides whether to pay for consultants which the letter from the IRC-IRB seems to indicate would be focused on issues unrelated to the need for a CRO and a multi-site study. February 21, 2003. IRB Review Tabled.The IRB informed MAPS that it cannot proceed with its review until it obtains the advice of two "qualified, objective psychiatric consultants," with fees for the consultants required to be paid by MAPS. An estimate of costs will be submitted to MAPS for approval prior to the IRB’s engaging the services of these consultants. February 14, 2003. More Documents. MAPS submitted a document detailing our standardized procedures for responding to "agitated subjects, or those with suicidal ideation associated with study procedures." We also submitted a document discussing the $175,000 bid that we received from a Contract Research Organization (CRO) for monitoring the study, along with information about the volunteer who would monitor the study for MAPS who had the exact same credentials as the person who would be assigned by the CRO. February 10, 2003. An Exhaustive and Exhausting Reply. MAPS submitted a twelve page basic reply (which included in a bit of comic relief a required menu of the snack foods and drinks that we would offer to subjects on the MDMA therapy days and our plans for handling the issue of food-related allergies), and assorted other documents including a letter from the researcher conducting the screening and outcome measures explaining that he had never met Dr. Mithoefer in person and had no particular interest in MDMA an eight page informed consent form for the friend/partner who would pick up the subject after the MDMA session a release form for sharing of subject’s personal medical information a wallet card for subjects showing there had participated in a legal MDMA research project in case they were drug tested for any reason in the several days after the experimental sessions during which time they might test positive for MDMA or amphetamines, and a confidentiality agreement for any physicians or therapists who referred subjects to the study. February 6, 2003. A Rapid Response. MAPS submitted a six page response focusing just on the issues of the Contract Research Organization and the multi-site study requirements, to be following up within a week or so with a more detailed discussion of these and other issues raised by the IRC-IRB. February 4, 2003. An Astonishingly Depressing Response. After the extensive discussions and good feelings of the January 28, 2003 in-person meeting, at which we seemingly discussed all the outstanding issues, the totally surprising reply sent by the IRC-IRB came with several scientifically misguided new demands. One of these (hiring a Contract Research Organization to take over the conduct of the study to avoid "unconscious bias") was unusual, exorbitantly expensive and unnecessary since the study was already a placebo-controlled, double-blind pilot study, with blinded, independent raters. Another (redesigning the study into a multi-site study with two different therapeutic teams) would probably not even be approved by the FDA since single-site studies to standardize the intervention precede multi-site studies. The IRC-IRB response, which included quite a few other requirements, indicated a profound misunderstanding by the IRC-IRB of the generally-accepted scientific research process and communicated that the IRC-IRB was deeply fearful of approving this protocol. Though I (Rick Doblin) am by nature happy and optimistic (which some friends of mine have teasingly referred to as evidence of MDMA brain damage), the IRC-IRB response resulted in two days of a dark depressive funk, the likes of which I haven’t felt for almost 30 years, back when I was working through early difficult LSD experiences. The resolution of the depression came with the decision to throw myself into responding in detail to the IRC-IRB letter, in the hopes that a clearer presentation on our part of the qualifications of our research team members, the logic behind our protocol design choices, and a willingness to give the IRC-IRB whatever information it asked for, would result in a return to generally-accepted scientific research principles. January 31, 2003. A Productive Dialogue. The January 28 meeting with the new IRB, at which Dr. Michael Mithoefer and Rick Doblin, Ph.D. appeared in person, involved a series of thoughtful questions about protocol design, risk assessment, confidentiality procedures and the nature of PTSD and currently available treatments. The meeting was characterized by mutual respect. We expect to receive a written report outlining the IRB’s decisions within the next several weeks. January 21, 2003. A Substantive Reply to IRB. MAPS submitted a series of documents today to the IRC-IRB, in response to their initial comments about the protocol which MAPS received on January 6. These documents represent a very substantial amount of staff time on MAPS’ part and include a twenty page primary response letter, a five page protocol summary, a two page plan for external evaluation, a two page phone script for the initial screening calls from potential volunteers, and a sixty page updated review of the MDMA literature published since our initial review was completed. Dr. Michael Mithoefer and Rick Doblin will meet in person with the IRB review panel on January 28 to discuss the issues under consideration. January 21, 2003. History Lesson for the DEA. MAPS submitted a letter to DEA from Rick Doblin concerning Dr. Michael Mithoefer’s July 2002 application for a Schedule I license to possess the MDMA that will be used in the MDMA/PTSD study. DEA has indicated that it has safety concerns that need to be addressed before it will issue the license. However, DEA is only legally charged with diversion control (preventing drugs approved for medical use to be diverted to non-medical uses) and has no legal mandate to review safety concerns, which are the responsibility of the FDA. In 1994, DEA tried to use similar arguments to justify its delay in issuing a Schedule I license to Dr. Donald Abrams for his FDA-approved marijuana/AIDS wasting study. Fortunately, FDA Commissioner Dr. David Kessler protested to Dr. Lee Brown, Director, Office of National Drug Control Policy (the Drug Czar), who wrote a letter to DEA Administrator Tom Constantine reminding him that DEA has no authority to review scientific matters. Dr. Brown told DEA that established lines of responsibility and authority should be respected and that national policy was to permit research with Schedule I drugs. MAPS’ letter reminds DEA of this history and urges it to respect the national interest in facilitating, and not obstructing, important research into new treatments for PTSD. January 6, 2003. Renewed hope. Today, MAPS received the initial set of comments of the IRC-IRB. My initial impression is that we will eventually be able to get some protocol approved, but that we might need to limit enrollment to more severe PTSD patients who have failed on psychotherapeutic treatments as well as an SSRI, and are 21 or older. We have been requested by the new IRB to provide a substantial amount of additional information. We hope to submit our response within several weeks for the next review, which Dr. Michael Mithoefer and I will probably attend on either January 28 or February 4. Despite the additional work that is ahead of us, it’s a profound relief that the new IRB is willing to approach this issue based on the science. December 17, 2002. A New Start. MAPS submitted the MDMA/PTSD protocol for review to the Independent Review Consulting Institutional Review Board (IRC-IRB), with the protocol to be discussed by the review board on January 2, 2003. Officials at the IRC-IRB have read the entire correspondence between MAPS and the Western IRB and have indicated that they will carefully review the protocol on its merits without bias due to the controversial nature of MDMA-assisted psychotherapy research. This IRB has a reputation for being rigorous but fair, a set of characteristics that inspires confidence. December 10, 2002. A Shameful Conclusion. On November 20, after the Western IRB decided not to review MAPS’ MDMA/PTSD protocol, Rick Doblin spoke to James Baldwin, Ph.D., Executive Director of the Western IRB. Dr. Baldwin informed Rick that he was not authorized to speak about what motivated the Western IRB to decide not to engage in a dialogue about the rationale for WIRB’s decision to revoke approval, to refuse to continue to review the protocol, and to refund MAPS’ fee. Instead, Dr. Baldwin suggested that for more information, Rick should contact Mr. Ron Warren, Senior Vice President of the Western IRB. After Rick Doblin made repeated attempts over several weeks to speak with Mr. Warren, his secretary finally informed Rick Doblin on December 10 that he was unwilling to speak and had nothing to add to the letter. So it ends, with a shameful silence. November 27, 2002. MDMA/PTSD Research in Israel. MAPS sent a draft of the MDMA/PTSD pilot study that MAPS is seeking to sponsor in Israel to Dr. Moshe Kotler and Dr. Jorge Gleser, Israeli Ministry of Health, for their review. MAPS’ conference on MDMA/PTSD research, held at Beer Yakov Mental Health Center near Tel Aviv on November 14 for members of the Israeli Ministry of Health, the Israeli Society of Addiction Medicine, and the Israeli Anti-Drug Authority, was very well received. The conference and the proposed pilot study were discussed in a positive article mentioned on the front page of Maariv, Israel’s second largest newspaper. The protocol design meeting, held at Beer Yakov on Nov. 17, was also productive, with the draft protocol submitted today reflecting design choices made at that meeting. November 20, 2002. Pathetic News. Ron Warren, Senior Vice President of the Western IRB, wrote a letter to Dr. Michael Mithoefer, reporting the outcome of the November 19 meeting of the WIRB’s Executive Policy Committee. The WIRB letter was two short sentences, "The Western Institutional Review Board, Inc. (WIRB) has made the decision not to provide institutional review board services for the Multidisciplinary Association for Psychedelic Studies (MAPS). Please find enclosed a refund of your previously paid fees, along with the material you submitted for IRB review."      The WIRB retreated from its supposed scientific rationale for revoking approval for MAPS’ MDMA/PTSD study, as described in its September 6, 2002 letter and critiqued in MAPS’ October 10 letter, and fell back on no rationale whatsoever. The WIRB has shown itself to be scientifically out of its depth and lacking of sufficient integrity to acknowledge its mistakes and refocus on a rational, data-based, risk/benefit analysis of MAPS’ MDMA/PTSD protocol.      Most importantly, MAPS will very soon start the process of submitting the protocol to another IRB for review. November 18, 2002. MAPS submitted a short letter to the Western IRB’s Executive Policy Committee, in advance of its November 19 meeting at which it will discuss its review of MAPS’ MDMA/PTSD protocol. The letter discussed MAPS’ Israeli MDMA/PTSD project, briefly reviewed US government and international treaty policies regarding research with Schedule I drugs, and reported that MAPS had submitted unpublished data to FDA about MDMA and heart valve tissue, data which the WIRB cited as partial justification for revoking approval which neither MAPS nor FDA had seen. October 17, 2002. A Surprising New Issue. After reviewing MAPS’ letter, Dr. James Baldwin of the WIRB informed RIck Doblin that the October 30 meeting was canceled, but not for the reasons MAPS had hoped. Dr. James Baldwin said that the meeting was "premature" because the WIRB now needed to convene its Executive Policy Committee (EPC) to discuss whether the WIRB should be involved with research with Schedule I drugs. The next EPC meeting is scheduled for November 19. The WIRB is no longer reviewing the protocol based on the science but on non-scientific, internal policy issues, not a very encouraging development. October 11, 2002. A Comprehensive, Strong Response. MAPS submitted a lengthy written response to the WIRB letter, along with 14 letters of information and support from MDMA scientists around the world. MAPS’ letter addressed every point raised in the WIRB letter and was so solid that we thought perhaps the WIRB would conclude that the October 30 meeting was not necessary. October 3, 2002. A Glimmer of Hope. Rick Doblin speaks with James Baldwin, Ph.D., Executive Director of the WIRB. Dr. Baldwin apologized for the tone of the WIRB letter and seemed to view favorably MAPS’ arguments. He was informed that the one scientist whom the WIRB letter claimed was against the study was actually in favor of the study (subject to two conditions that MAPS could easily agree with), that the second scientist cited in the WIRB letter was strongly in favor of the study, and that the third scientist was probably not fully informed about the details of the protocol and was neither opposed to or in favor of the study. Dr. Baldwin tentatively scheduled a meeting between Rick Doblin and Michael Mithoefer and the WIRB for October 30, in Olympia, Washington. September 27, 2002. Outrageous News. Dr. George Ricaurte publishes an article in Science reporting on primate data that he claims suggests that even one night’s recreational use of Ecstasy can lead to Parkinson’s. This government-funded research, which ignored the high mortality rate of the test animals and directly contradictory human data, is a classic example of risk amplification and the demonization of illegal drugs. MAPS obtained a copy of this article before publication and responded by sending out our first press release ever. MAPS’ critique was favorably reported in articles in the New York Times and Washington Post and elsewhere. MAPS has also written a letter to the editor of Science. September 6, 2002. Terrible News. The Western IRB, which approved the MDMA/PTSD protocol on July 10, informed us by letter that approval was withdrawn. The revocation was based on secondhand reports of conversations (not on data!) that a WIRB staff person had with three MDMA researchers. The WIRB letter was written in a surprisingly insulting manner and contained numerous mistakes. MAPS was not informed that the protocol was being reevaluated and did not have an opportunity to respond to the reports by the WIRB staff person, who didn’t like the fact that the WIRB had approved the protocol. July 17, 2002. Tremendous news. On July 10, we received word that the Institutional Review Board (IRB) had approved MAPS’ MDMA/PTSD study! We can now definitely say that the US study will take place. Dr. Michael Mithoefer still needs to obtain his DEA Schedule 1 license, which should take about 4-6 weeks, but this is just a matter of time There is now an excellent chance that the Israeli Ministry of Health will approve an Israeli MDMA/PTSD study. Michael and I are tentatively planning to go there in late Sept. or early Oct. for a one-day seminar organized by the Ministry to discuss the latest findings in MDMA research, and protocol design options for the Israeli study. Here are the financial implications: We still need to raise an additional $60,000 for the US MDMA/PTSD study and another $60,000 for the Israeli study. MAPS is also seeking $10,000 for our National Institute of Mental Health (NIMH) grant application for support for the development of a treatment manual that describes in detail hw MDMA-assisted psychotherapy for PTSD should be conducted and provides specific ways to evaluate whether the therapy technique itself is being delivered appropriately. We are also seeking $20,000 for our ongoing MDMA literature review. Any help or suggestions would be greatly appreciated. June 19, 2002. MDMA/PTSD protocol submitted to the Western Institutional Review Board (WIRB). Review expected to take 3-5 weeks. June 14, 2002. FDA gives final approval to conduct the treatment sessions in Dr. Michael Mithoefer’s office, with a "crash cart" and an Emergency Room doctor and nurse in the next room in case they are needed. May 14, 2002. Conference call with Dr. Mithoefer, Rick Doblin and FDA o fficials, in which we come to tentative agreement to conduct the study in Dr. Mithoefer’s office, as long as we hire both an ER doctor and nurse to sit in the room. May 10, 2002. FDA rejects our request, primarily saying that they would like a larger emergency response team. March 14, 2002. Request submitted to FDA to change the location of the treatment sessions from the Medical University of South Carolina (MUSC) to Dr. Mithoefer’s office. We propose renting a "crash cart" and hiring an emergency room nurse to be on site in the room next to the treatment room for the first five hours of each session, in case Dr. Michael Mithoefer and Annie Mithoefer, R.N. need help responding to an adverse event. November 28, 2001. The fourth patient in the Spain MDMA/PTSD dose-response study was treated on November 28, 2001. We have now completed the 50 mgs dose group (3 patients received 50 mgs and 1 received a placebo). The next dose level is 75 mgs (5 patients will receive 75 mgs and 2 will receive a placebo). November 2, 2001. It’s my pleasure to report some excellent news. About 10 AM, Friday, November 2, FDA contacted me to say that MAPS’ MDMA/PTSD protocol was approved. This approval marks the culmination of 16 years of efforts to obtain permission from FDA for MDMA-assisted psychotherapy research, since MDMA was criminalized in 1985. This approval also marks the beginning of what I hope will be a $5 million, 5-year project to develop MDMA into a prescription medicine.       On Wednesday, Dr. Michael Mithoefer, the principal investigator, and I had a conference call with FDA during which we discussed various design issues. The conference call was calm, serious and respectful. We agreed to make several design changes, mainly closer monitoring of blood pressure and omitting the opportunity for placebo subjects who still met inclusion criteria for PTSD at the final evaluation to enroll in an open label extension study during which they would receive MDMA. We argued against several other possible changes, mainly the idea that patients should be required to have had prior experience with MDMA. On Thursday, I faxed an addendum specifying the changes we had agreed upon and the places where the protocol needed to be changed. Last night, I saw on CNN that anthrax was discovered in the FDA mailroom at Rockville, where the FDA officials reviewing the protocol work. Today, FDA officials were still at work and informed me that the protocol was approved without the need for any additional changes.       Of course, we still need to obtain Institutional Review Board approval from the Medical University of South Carolina. This should take several additional months.       I’ve already let the Israeli Ministry of Health know that the FDA approved the study. According to Dr. Moshe Kotler, the principal investigator of the proposed Israeli MDMA/PTSD protocol, FDA approval was need for an MDMA/PTSD study before he would feel comfortable submitting a protocol to the Ministry. The subjects in the ongoing Spain MDMA/PTSD study are women survivors of sexual assault with chronic PTSD. The subjects in the FDA-approved study are women and men survivors of criminal assault with chronic PTSD. The Israeli study will hopefully include subjects whose PTSD was the result of war and terrorism.       The formal approval letter from FDA will arrive next week. -- Rick Doblin, Ph.D. October 1, 2001. MAPS submitted to the FDA today the protocol for Dr. Michael Mithoefer and Dr. Mark Wagner’s MAPS-supported pilot study into the use of MDMA-assisted psychotherapy in the treatment of patients who have experienced criminal victimization and as a result have suffered from chronic, treatment-resistance posttraumatic stress disorder (PTSD). The submission of this protocol to FDA marks a major milestone in the history of MAPS, and hopefully in the history of MDMA research. FDA has 30 days to respond to the protocol. We fully expect FDA eventually to approve the study in some form. (Faster download - without individual case reports from Phase 1 study; longer version - with individual case reports from Phase 1 study) July 18, 2001. As part of its submission to FDA of a protocol designed to study the use of MDMA in the treatment of PTSD, MAPS’ commissioned an extensive review of the scientific literature on MDMA. This literature review was developed under the direction of Matt Baggott with Ilsa Jerome, Ph.D., and is now being made available to regulatory agencies, other researchers and the public. The literature review will be updated on a regular basis as new research is published. July 16, 2001. A draft of the MDMA/PTSD protocol that MAPS has been working for 2 years to develop, with Dr. Michael Mithoefer and Mark Wagner, Ph.D., at the Medical University of South Carolina, has now been posted to the web. The protocol will submitted to FDA shortly after NIDA’s scientific meeting on MDMA, held at the National Institutes of Health campus in Bethesda, MD, on July 19-20. If and when it becomes approved in some form, this protocol will be the first FDA-approved study of the therapeutic use of MDMA since MDMA was placed in Schedule 1 in 1985. March 19, 2001. The US Sentencing Commission held an open hearing concerning its proposal to increase penalties on MDMA. Testimony about MDMA opposing the increase was presented by Rick Doblin, Ph.D., David Nichols, Ph.D., Charles Grob, M.D., Julie Holland, M.D. and Richard Glen Boire, Esq. Testimony about legal issues by opponents of the increase was presented by Ed Mallet, Executive Director of the National Association of Criminal Defense Lawyers (NACDL), Julie Stewart, Executive Director of Families Against Mandatory Minimums (FAMM), and Bill McColl, Legislative Director of The Lindesmith Center/ Drug Policy Foundation (TLC/DPF). The testimony had little effect and the Sentencing Commission recommended substantial increases in penalties. MDMA is now, dose for dose, punished more heavily than heroin.       Judge Diane Murphy, Chair of the U.S. Sentencing Commission, explained the rationale behind the Commission’s recommendation during a hearing of the Senate Caucus on International Drug Control on March 21, 2001. (See also visual presentation) February 3, 2001. MAPS convened a protocol design meeting in San Francisco to discuss the details of a protocol evaluating the use of MDMA-assisted psychotherapy in the treatment of Post-Traumatic Stress Disorder (PTSD). The meeting included. among others, the principle investigator and therapists of the South Carolina team (Dr. Michael Mithoefer and Annie Mithoefer, RN), the MAPS team that has for the last year and a half been reviewing the MDMA literature for submission to FDA (Matt Baggott, Ilsa Jerome), the team that has been creating the MDMA bibliography of all scientific papers on MDMA published in peer-reviewed journals (from erowid.org), and scientific consultants including Dr. Charles Grob, Dr. George Greer, and Dr. Dave Nichols. The meeting was quite productive, with the protocol expected to be submitted to FDA in April 2001. February 2, 2001. Rick Doblin outlines MAPS’ strategy for the development of the therapeutic use of MDMA into an FDA-approved prescription medicine, at the State of Ecstasy conference in San Francisco, sponsored by the Lindesmith Center- Drug Policy Foundation. Additional transcripts of other speakers have been helpfully archived by an anti-drug group. November 9, 2000. The first patient was treated in the MAPS-supported MDMA/PTSD study being conducted in Madrid, Spain, under the director of José Carlos Bouso, Ph.D. candidate. José Carlos and Marcela Ot’alora were the co-therapists. The four hour session went very well and the patient seemed to have gotten to a deeper, more therapeutic level. Of course, we won’t know for some time whether the patient received a dose of 50 mgs or a placebo! What we do know is that study is off to a great start. Read more about this study, including the protocol and informed consent form. November 1, 2000.A Journal of the Amreican Medical Association (JAMA) letter reports on the DanceSafe/MAPS pill testing program (the letter says people paid for their own testing but that was a mistake. MAPS paid for most of the testing of these pills). August 15, 2000. A discussion about "Raves, Ecstasy and Youth" was held at the Shadow Convention 2000 in Los Angeles. A celebrity panel of MDMA researchers, experts and psychonauts was assembled by the Lindesmith Center/Drug Policy Foundation; video and audio coverage of this unique event can be found at the Shadow Conventions 2000 website. May 5-6, 2000. The California Association of Toxicologists held a conference in North Hollywood, California, the first day of which was devoted to drugs that are commonly found at raves. Read summary and comments by Earth and Richard G. Boire. March 2000 - New York Lindesmith Center. Hear in RealAudio MDMA (’Ecstasy’) Research: When Science and Politics Collide. Sound quality is excellent except for the first few minutes, so be patient. Speakers: Julie Holland, MD, attending psychiatrist, Bellevue Hospital Psychiatric Emergency Room and faculty, NYU School of Medicine; John P. Morgan, MD, professor of pharmacology, City College of New York; and Rick Doblin, president, MAPS) and Ph.D. candidate, Kennedy School of Government, Harvard University, assessed scientific and political efforts to conduct MDMA research in the US and abroad. See also the transcript of Holland’s talk. February 2000 - Spain. A pilot study of MDMA therapy in the treatment of PTSD has been approved and will be the first formal therapy study with MDMA ever conducted. (Read current update. MAPS has pledged $54,000 for this study; we have raised $23,000 and are seeking additional contributions. Autumn 1999 - MAPS Israel MDMA Conference. MAPS organized an international symposium on the medical utility of MDMA. Talks from this event, held August 31 to September 1, 1999, are posted on this site (talks by George Greer, Juraj and Sonja Styk and Mark Kleiman). See also video clips of some of the talks. July 24, 1999 In a teleconference with the FDA concerning MDMA psychotherapy research to treat anxiety, depression and pain in cancer patients, the FDA indicates a willingness to approve a "proof of principle" study. MAPS-Sponsored Clinical Trials: MDMA in the Treatment of PTSD MDMA/PTSD U.S. Pilot Study (Completed September 2008) MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Principal Investigator: Michael Mithoefer, M.D., with co-therapist Ann Mithoefer, B.S.N. Location: Charleston, SC (USA) MAPS’ flagship Phase 2 pilot study is the first-ever protocol evaluating MDMA’s therapeutic applications in clinical trials conducted under an FDA IND. Like all of MAPS’ psychedelic-assisted psychotherapy studies, the protocol is randomized, double-blind and placebo-controlled. All twenty-one subjects with treatment-resistant PTSD, as a result of sexual abuse, crime, or war, have completed the experimental treatment. The study was completed in September 2008 with remarkably promising results. We have submitted a manuscript to a journal for publication of the study's results. Dr. Mithoefer's MAPS-sponsored MDMA/PTSD protocol The study has cost $1.2 Million; all of which has been raised. MDMA/PTSD U.S. Study (Veterans of War) A Randomized Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 16 Veterans with Chronic Posttraumatic Stress Disorder (PTSD) Principal Investigator: Michael Mithoefer, M.D., with co-therapist Ann Mithoefer, B.S.N. Location: Charleston, SC (USA) This pilot Phase 2 study will examine the safety and efficacy of MDMA-assisted psychotherapy in sixteen veterans with war-related PTSD, and will seek to enroll roughly equal numbers of men and women. Since many veterans with PTSD have not been offered and/or have declined medication or psychotherapy for their PTSD, this study will include veterans with chronic PTSD of at least six months duration. To ensure maximal scientific objectivity, this protocol is randomized, triple-blind and placebo-controlled. According to European Medicines Agency (EMEA) Guidelines for the development of medicines for PTSD, it is important to conduct clinical trials in homogenous populations. The findings of this study in veterans with war-related trauma will be compared to the findings from our first MDMA/PTSD pilot study, which consisted primarily of women survivors of sexual abuse and assault. Previous studies suggest that war-related PTSD may be more prevalent and harder to cure than PTSD caused by other types of trauma, and out study may help to compare the effect of trauma etiology on treatment efficacy. (see references) MDMA/PTSD in U.S. War Veterans Protocol submitted to the FDA on December 23, 2009. Part 1, Part 2, Part 3 (PDF) This study will cost $500,000, and we still need to raise $475,000. Study Timeline FDA IND application on December 23, 2009 Submission Letter to FDA (PDF) IND form 1571 (PDF) Principle Investigator form 1572 (PDF) (PDF) Investigator's Brochure (PDF) Original Protocol Part 1, Part 2, Part 3 (PDF) Curriculum vitae of Principle Investigator (PDF) Curriculum vitae of Co-Investigator (PDF) Curriculum vitae of Co-Investigator (PDF) Template Informed Consent (PDF) Draft Case Report Forms (PDF) Our FDA IND application has been approved with no changes required on February 1, 2010! Approval Letter from FDA (PDF) References Foa, E.B., et al., Effective Treatments for PTSD, Practice Guidelines from the International Society for Traumatic Stress Studies. Second ed. 2009, New York, NY: Guilford Press. Stein, M.B., N.A. Kline, and J.L. Matloff, Adjunctive olanzapine for SSRI-resistant combat-related PTSD: a double-blind, placebo-controlled study. Am J Psychiatry, 2002. 159: 1777-9. Prigerson, H.G., P.K. Maciejewski, and R.A. Rosenheck, Combat trauma: trauma with highest risk of delayed onset and unresolved posttraumatic stress disorder symptoms, unemployment, and abuse among men. J Nerv Ment Dis, 2001. 189: 99-108. Training Protocol for MDMA/PTSD Researchers/Phase 1 Psychological Effects Study Psychological effects of MDMA administration in normal volunteers training to conduct MDMA-assisted psychotherapy research Principal Investigators: Michael Mithoefer, M.D. and Ann Mithoefer, B.S.N. Location: Charleston, SC This Therapist Training/ Phase 1 psychological effects protocol is a placebo-controlled, double-blind, randomized, cross-over study that allows MAPS to administer a single MDMA-assisted psychotherapy session to therapists as part of their training to conduct MAPS' MDMA/PTSD studies, while also conducting a series of evaluations of the psychological effects of MDMA administered to healthy volunteers in a therapeutic context. This protocol is based in part on a precedent from the 1970s: Dr. Albert Kurland's LSD research team at Spring Grove Hospital in Maryland had FDA permission to administer LSD to help train nurses, attendants and others working with patients in clinical studies, and to mental health professionals (doctors, therapists, counselors, priests, rabbis) to help them better understand patients or congregants who had experienced LSD. Over 100 people received LSD in those training sessions. MAPS submitted letters to FDA from one of the researchers conducting that program, Johns Hopkins researcher William Richards, Ph.D., and from Daniel Helminiak, Ph.D., Ph.D., LPC, a participant in that program. Below you will find a partial list of documents that MAPS has submitted for this study. The list is not comprehensive because the IRB requested that we not include any proprietary documents and information. On October 3, 2009, MAPS received a letter from the US FDA allowing the study to proceed. We received IRB approval on December 21, 2009. We plan to enroll the first group into this study in April 2010. Therapist Training Protocol/Phase 1 Psychological Effects: Amendment 2 approved by IRB 12/21/09 (PDF) This study will cost $50,000, all of which remains to be raised. Study Timeline FDA IND application on June 22, 2009 Submission Letter to FDA (PDF) IND form 1571 (PDF) IND form 1571 (PDF) Investigator's Brochure (PDF) Original Protocol (PDF) FDA Submission of Amendment 1 on September 16, 2009 Protocol Amendment 1 (PDF) MT-1 FDA approval letter (PDF) IRB submission of Amendment 1 study materials on October 15, 2009 Submission Letter to IRB (PDF) Principle Investigator Form 1572 (PDF) Protocol Amendment 1 (PDF) Principle Investigator CV (PDF) Co-Investigator CV (PDF) Investigator Medical License (PDF) MP-1 Preliminary Data (PDF) Study Rules (PDF) Subject Wallet Card (PDF) SUDS test (PDF) NEO test (PDF) Interpersonal Closeness Test (PDF) IRB correspondence (PDF) The IRB deferred approval of the study on October 26, 2009 We amended the study and re-submitted to the IRB on December 2, 2009 IRB Submission Letter (PDF) MAPS Response to Deferral (PDF) Principle Investigator Form 1572 (PDF) Helminiak Letter of Support (PDF) Johnson Letter of Support (PDF) Richards Letter of Support (PDF) Protocol Amendment 2 (PDF) Case Report Forms (PDF) Template Therapy Manual (PDF) Johnson et. al. 2008 (PDF) IRB questions about study (PDF) IRB correspondence on December 14, 2009 (PDF) IRB conditional approval on December 16, 2009 (PDF) IRB correspondence on December 17, 2009 (PDF) IRB correspondence on December 21, 2009 (PDF) The IRB officially approved the study on December 30, 2009 We submitted Amendment 2 for FDA Approval on December 30, 2009 FDA Submission Letter (PDF) This study has been fully approved. MDMA/PTSD Switzerland Study Principal Investigator: Peter Oehen, MD, with co-therapist Verena Widmer, RN Location: Solothurn (Switzerland) This study is currently underway; all twelve subjects with treatment-resistant PTSD from any cause have undergone the experimental treatment. The last subject's last visit will take place in January 2010. Our Swiss MDMA/PTSD pilot study has full approval from an Ethics Committee (Swiss IRB equivalent) and SwissMedic (FDA equivalent). The protocol has also been submitted to and accepted by FDA under MAPS’ Investigational New Drug (IND) for MDMA. As a result, the study fits into MAPS’ initiative to develop MDMA into a prescription medicine approved by both the FDA and the European Medicines’ Agency (EMEA). Swiss MDMA/PTSD pilot study protocol The study will cost $260,000; $55,000 is still needed. MDMA/PTSD Israel Study Principal Investigator: Moshe Kotler, MD, with co-therapists Sergio Marchevsky, MD, Rakefet Rodrigez, MD, and Marina Kupchik Location: Beer Yaakov Mental Health Center (Israel) This study has full approval from the Israeli Ethics Committee and Ministry of Health and it has enrolled several subjects. The experimental treatments are being conducted at Beer Yaakov Mental Health Center, near Tel Aviv, under the direction of Principal Investigator Moshe Kotler, M.D., former chief psychiatrist of the Israeli Defense Forces and current Chair, Department of Psychiatry, Sackler School of Medicine, Tel Aviv University. The study will evaluate twelve subjects with treatment-resistant PTSD, mostly war- or terrorism-related PTSD. Like MAPS’ Swiss MDMA/PTSD study, the protocol has been submitted to and accepted by FDA under MAPS’ IND for MDMA, and is part of MAPS’ initiative to develop MDMA into a prescription medicine approved by both the FDA and the EMEA. MAPS has sponsored three international scientific conferences in Israel on MDMA research to facilitate the protocol approval process. Israeli MDMA/PTSD pilot study protocol The study will cost $126,000; $100,000 is still needed. MDMA/PTSD Canada Study MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Principal Investigator: Ingrid Pacey, MD and Andrew Feldmar, PhD Location: Vancouver, BC (Canada) This study has full approval from an Institutional Review Board (IRB) and from Health Canada. Data will also be submitted to the US FDA. Psychiatrist Ingrid Pacey, MD, who is a distinguished Holotropic Breathwork facilitator will be co-therapist along with psychologist Andrew Feldmar, PhD. We are currently working to obtain an import permit to import the MDMA into Canada from our pharmacist in Switzerland. This will be the first such permit obtained in history. Once we obtain this permit, we expect to begin enrollment in Spring 2010. Canadian MDMA/PTSD pilot study protocol The study will cost $290,000; $279,000 of which remains to be raised. MDMA/PTSD Jordan Study MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Principal Investigator: Nasser Shuriquie, M.D. and TBD Location: Amman, Jordan This study is currently under development. It will be conducted under the direction of psychiatrist Nasser Shuriquie, M.D. in Amman, Jordan. We hope to enroll Iraqi refugees living in Jordan who have PTSD, along with other Jordanians suffering from PTSD. The study will cost $136,000; of which we still need $51,000. We are currently preparing for submission to regulatory agencies in Jordan. Current versions of these documents are below: Original protocol (PDF) One Page Protocol Synopsis (PDF) Case Report Forms (PDF) Curriculum Vitae of Principle Investigator (PDF) MDMA/PTSD Spain Study MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Principal Investigator: Jose Carlos Bouso, Ph.D. Location: Barcelona, Spain This study is currently under development, and is seeking a grant of $200,000 from the Catalan Ministry of Health. Jose Carlos Bouso was the principal investigator in MAPS' first MDMA-assisted psychotherapy for PTSD study in Madrid, which was cancelled due to political reasons. Bouso later published a paper with findings from this study. The study will initially cost $80,000; all of which remains to be raised. MDMA for Cancer and End-of-Life Anxiety MDMA-Assisted Psychotherapy in the Treatment of Anxiety Secondary to Advanced Stage Cancer MDMA-Assisted Psychotherapy in the Treatment of Anxiety Secondary to Advanced Stage Cancer Sponsor/Principal Investigator: John Halpern, M.D. Location: McLean Hospital, Harvard Medical School, Belmont, MA (USA) Dr. Halpern is the Sponsor/Investigator. In his FDA IND application, he cross-referenced MAPS’ IND for MDMA and MAPS will have full access to the data generated from his study. MAPS conducted the design and protocol approval process for this study through a direct gift to McLean Hospital. This study of twelve subjects is also being conducted under US FDA IND and has received IRB approval and DEA registration.The first subject has completed the experimental treatment. Protocol submitted to FDA on November 26, 2004 (in HTML or PDF format) The study will cost $310,000; all of which has been raised.

Dear Readers, please do not assume that you understand anything you read on this blog.(:-)