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MAPS BULLETIN
MAPS Bulletin Spring 2014: Special Edition: Psychedelics and Education
 
Research > MDMA-Assisted Psychotherapy

We are studying whether MDMA-assisted psychotherapy has the potential to heal the psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas.

Our highest priority project is funding clinical trials of 3,4-methylenedioxymethamphetamine (MDMA) as a tool to assist psychotherapy for the treatment of posttraumatic stress disorder (PTSD). Preliminary studies have shown that MDMA in conjunction with psychotherapy can help people overcome PTSD, and possibly other disorders as well. MDMA is known for increasing feelings of trust and compassion towards others, which could make an ideal adjunct to psychotherapy for PTSD.

In MDMA-assisted psychotherapy, MDMA is only administered a few times, unlike most medications for mental illnesses which are often taken daily for years, and sometimes forever.

MDMA is not the same as "Ecstasy" or "molly." Substances sold on the street under these names may contain MDMA, but frequently also contain unknown and/or dangerous adulterants. In laboratory studies, pure MDMA has been proven sufficiently safe for human consumption when taken a limited number of times in moderate doses.

MAPS is undertaking an eight-year, $18.5 million plan to make MDMA into an FDA-approved prescription medicine by 2021, and is currently the only organization in the world funding clinical trials of MDMA-assisted psychotherapy. For-profit pharmaceutical companies are not interested in developing MDMA into a medicine because the patent for MDMA has expired. The idea of using MDMA to assist psychotherapy of any kind for any specific clinical indication has long been in the public domain.

Download our Clinical Development Plan.

Explore MAPS in the Media for the latest headlines.

View the timelines for each study.

Learn about MDMA-assisted therapy for social anxiety in autistic adults at mdma-autism.org.

MDMA Research News Timeline

contract MDMA Research Timeline

Showing 25 of 655 total entries. View the full timeline of all MAPS MDMA/PTSD projects.


August 5, 2014

UK Brain Imaging Study to Explore MDMA’s Effects on PTSD without Therapy

The Cardiff University MDMA for PTSD Project

In Association with MAPS and The Beckley Foundation

Since meeting Rick Doblin and Michael Mithoefer in Basel in 2006 it has always been my intention to bring an MDMA for PTSD study to the UK. After meeting Jon Bisson, an ex-Marine and now the PTSD lead at the UK’s Royal College of Psychiatrists, in 2010 our original intention was to repeat Michael’s 2010 published study, delivering MDMA Psychotherapy to patients with treatment-resistant PTSD.

But in 2012, after an initial funding rejection from the Medical Research Council for a proposed large-scale therapeutic project, we decided to scale things down. Hooking up with the neuroimaging expertise of Robin Carhart-Harris, Ph.D., and Prof. David Nutt at Imperial College London and Richard Wises’ fMRI department at Cardiff University we designed a study that looks primarily at the neurobiological mechanisms behind MDMA’s effects on the core features of PTSD. There have already been neuroimaging studies on patients with PTSD and on healthy people taking MDMA, but ours will be the first time fMRI has looked specifically at patients with PTSD under the direct effect of MDMA. This study will be funded by MAPS, Beckley Foundation and an anonymous donor. There is no therapeutic component to the study, but subjects will be able to request therapeutic support if they feel it is necessary since for most of their MDMA experience they will not be in the scanner. This study will also explore MDMA’s potential beneficial effects without delivering formal therapy.

We know from the results of underground MDMA therapy, from anecdotal studies of the 1980s, and from Michael and Peter’s recent work that MDMA Psychotherapy works, but there remains a lack of data about the mechanism behind its effects in PTSD. There are neuroimaging studies on patients with PTSD and on healthy people taking MDMA, but ours will be the first time fMRI has looked specifically at patients with PTSD being given MDMA. We hope this initial, mechanism of action phase of the Cardiff University MDMA for PTSD Project will generate supporting future studies designed to demonstrate MDMA’s overall efficacy and safety. It provides important data to support Phase 2 of the drug’s clinical trials and is therefore a crucial part of the broader project to explore how MDMA works in the brain ahead of Phase 3 studies, which are aimed at seeing MDMA licensed as a medicine to be used by clinicians to treat PTSD.

We are now at the stage of submitting for ethical approval (like the US IRB process) and seeking a Schedule 1 license for MDMA to be used at Cardiff. Rather excitingly, Mat Hoskins, the other study doctor on the project, and myself are soon to undergo MDMA Therapy training with Michael and Annie Mithoefer. This initial phase the Cardiff project should begin in early 2015 and take around two years to complete. Thereafter we hope to design further studies to explore different models for delivering MDMA Therapy for PTSD. It may be that a form of MDMA Therapy can be used in brief, focused, more clinically deliverable formats than some of the current proposed models.

The financial, academic, and inspirational support from MAPS has been invaluable; the lubrication that got the cogs of our machine turning. The Beckley Foundation has also been involved in the development of our project. We look forward to many years of continued close work with these and other members of the international psychedelic research community.

—Dr Ben Sessa MBBS (MD) BSc MRCPsych

Consultant Child and Adolescent Psychiatrist in Substance Misuse and Psychedelic Researcher, Bristol and Cardiff, UK

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August 5, 2014

Canada: New Co-Investigators Participate in Therapist Training

From August 1-5, 2014, Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., led a two-and-a-half day training in Vancouver, BC, for the newly added co-investigators in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD, Donna Dryer, M.D., and Richard Yensen, Ph.D. Also participating in the training were Phil Wolfson, M.D., Julane Andries, Cody Swift, Linnae Ponté, and Shannon Petitt who will each be co-conducting experimental sessions in our upcoming study of MDMA-assisted psychotherapy for anxiety associated with advanced-stage illness. On July 22, 2014, MAPS Director of Clinical Research Amy Emerson and Clinical Research Scientist Berra Yazar-Klosinski, Ph.D., conducted the Canadian PTSD study initiation visit via remote teleconference to prepare study staff and trial documentation to begin screening and enrolling subjects. MAPS is sponsoring this study in association with MAPS Canada, the first and only Canadian organization dedicated to psychedelic research and education, now able to receive tax-deductible contributions in Canada.

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July 23, 2014

Boulder: 10th Subject Treated, Two More Subjects Enrolled

On July 6, 2014, the 10th subject was treated in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. This subject was enrolled on June 13. The 11th subject was enrolled on July 23. This study will enroll 23 subjects with chronic, treatment-resistant PTSD from sexual assault, violent crime, war, or any other cause. We are currently preparing a new study amendment proposing greater variability in dosing options for subjects’ unblinded sessions, giving subjects randomly assigned to the medium dose (100 mg) condition the option of selecting either a medium or full (125 mg) dose for their third experimental session. “The Boulder study is at its halfway point and the results have been encouraging and significant," reports study Principal Investigator Marcela Ot’alora. "We have witnessed people change in ways they did not think possible. I am continuously amazed by our participants’ willingness to embark on a journey they know little about, while having their world disrupted and ultimately doing tremendous work.”

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July 18, 2014

Social Anxiety in Autistic Adults: Third Subject Enrolled

On July 18, 2014, the third subject was enrolled in our new study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum. The first treatment sessions are now scheduled to take place in August. This exploratory pilot study in 12 subjects will focus on enhancing functional skills and quality of life in autistic adults with social anxiety. "We’re looking for something to facilitate positive, ongoing change," Principal Investigator Charles Grob, M.D., told the Los Angeles Daily News on August 2. "You can’t take an autistic person and make them un-autistic, but you can treat the overwhelming social anxiety." This study is being conducted in affiliation with the Los Angeles Biomedical Research Institute.

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June 24, 2014

Boulder: Three More Subjects Enrolled; Study Size Increased to 23 Subjects

From June 20-24, 2014, the seventh, eighth, and ninth subjects were treated in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. Our application to increase the study size from 17 to 23 subjects was approved by the Institutional Review Board on May 6, and passed the Food and Drug Administration’s 30-day review period on June 1. We have increased the size of this study in order to get a better sense of the range of outcomes from different co-therapist teams—important data for calculating the size of our Phase 3 studies—and to compare the effectiveness of different doses of MDMA combined with psychotherapy for treating PTSD. This study is investigating the safety and effectiveness of MDMA-assisted psychotherapy for subjects with chronic, treatment-resistant PTSD resulting from sexual assault, violent crime, war, or any other cause. “I feel so blessed to have been in this study,” reported one female participant in an email. “I feel like I have access to much more of myself and the part of me that is healthy has become stronger.”

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June 17, 2014

U.S. Veterans: 19th Subject Enrolled and Treated

On June 17, 2014, the 19th subject was treated in our ongoing study of MDMA-assisted psychotherapy in 24 U.S. veterans, firefighters, and police officers with chronic, treatment-resistant PTSD. This subject was enrolled on June 12. Data from this study will be combined with data from our two completed and three other ongoing Phase 2 studies of MDMA-assisted psychotherapy for PTSD, and used to design future Phase 3 studies. This study is led by Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., in Charleston, South Carolina. Virgil Huston, an Iraq veteran who participated in the study, wrote to MAPS after he had completed treatment. He wrote: “As a patient who has a bit of survivor’s guilt since I know many others who need this treatment as badly as I did, I have trouble accepting 2021 as the earliest date this can become widely available. Maybe you guys are the realistic ones, but keeping this away from people until then just doesn’t pass the logic test.” Download the study protocol

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June 15, 2014

Israel:  Fourth Subject Treated

On June 15, 2014, the fourth subject was treated in our ongoing Israeli study of MDMA-assisted psychotherapy for 10 subjects with chronic, treatment-resistant PTSD. The first subject was treated in April 2013. This study is being conducted at the Beer Yaakov Mental Hospital in Israel and led by Principal Investigator Moshe Kotler, M.D. Recent and ongoing violence in Israel has called renewed attention to the importance of conducting research for PTSD in Israel. In an email to MAPS Executive Director Rick Doblin, Ph.D., Israeli study coordinator Dafna Bornstein-Lavi reported, “Again I’m under the table in Beer Yaakov with missiles flying over my head.”

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May 27, 2014

Boulder: Three More Subjects Enrolled; Study Size Increased to 23 Subjects

On May 27, 2014, the seventh, eighth, and ninth subjects were enrolled in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. One subject voluntarily withdrew from the study following their first experimental session on May 2, making it two subjects who have now dropped out of this study. (Note: We are now subtracting dropouts from the total enrolled to more accurately reflect study progress.) On May 15, the Institutional Review Board approved our amendment to increase the size of the study from 17 to 23 subjects. The U.S. Food and Drug Administration 30-day review period passed on June 1, enabling us to go forward with the amendment. We will also need approval from the Drug Enforcement Administration for the additional MDMA needed. This study is investigating the safety and effectiveness of MDMA-assisted psychotherapy for subjects with chronic, treatment-resistant PTSD resulting from sexual assault, violent crime, war, or any other cause. This study is also testing the use of interns as one half of our male/female co-therapist teams.

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May 23, 2014

U.S. Veterans: 18th Subject Enrolled and Treated

On May 23, 2014, the 18th subject was treated in our ongoing study of MDMA-assisted psychotherapy in 24 U.S. veterans, firefighters, and police officers with chronic, treatment-resistant PTSD. This subject was enrolled on May 16. On May 7, the 11th subject completed their one-year follow-up evaluation. This study is led by Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., in Charleston, South Carolina.

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May 13, 2014

Israel: Fourth Subject Enrolled (corrected)

On May 13, 2014, the fourth subject was enrolled in our ongoing Israeli study of MDMA-assisted psychotherapy for 10 subjects with chronic, treatment-resistant PTSD. The subject prematurely reported last month as the fourth enrollment was not formally enrolled after the investigators determined the subject would not be appropriate for the study. This study is being conducted at the Beer Yaakov Mental Hospital in Israel and led by Principal Investigator Moshe Kotler, M.D.

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May 6, 2014

U.S. Veterans: 17th Subject Enrolled and Treated

On May 6, 2014, the 17th subject was treated in our ongoing study of MDMA-assisted psychotherapy in 24 U.S. veterans, fire fighters, and police officers with chronic, treatment-resistant PTSD. This subject was enrolled on April 9. This subject has also enrolled in our new sub-study of the physiological effects of MDMA-assisted psychotherapy, which will examine heart rate variability (HRV) and functional magnetic resonance imaging (fMRI) and explore correlations with clinical outcomes. Overall goals for this study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted psychotherapy in people suffering from war-related trauma; (2) comparing the effectiveness of the treatment for people with war-related trauma versus for people with trauma related to sexual abuse, assault, and other causes; (2) comparing different doses of MDMA; and (3) increasing awareness and support for our work by assisting a publicly recognized population.

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April 18, 2014

Boulder: Sixth and Seventh Subjects Treated, Amendment Submitted to FDA and IRB

On April 18, 2014, the sixth subject was treated in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The seventh subject was enrolled on March 27, and received the first MDMA-assisted psychotherapy session on May 2. Additionally, on May 1, we submitted a revised protocol for review to the Institutional Review Board proposing to increase the study size from 17 to 23 subjects , and on May 2 we submitted the revised protocol to the U.S. Food and Drug Administration. This study is investigating the safety and effectiveness of MDMA-assisted psychotherapy for subjects with chronic, treatment-resistant PTSD resulting from sexual assault, violent crime, war, or any other cause.

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April 16, 2014

Israel: Fourth Subject Enrolled

On April 16, 2014, the fourth subject was enrolled in our ongoing Israeli study of MDMA-assisted psychotherapy for 10 subjects with chronic, treatment-resistant PTSD. Goals for this study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted psychotherapy for subjects with PTSD mostly related to war and terrorism, (2) comparing the effectiveness of different doses of MDMA for therapy and double-blind, (3) working in direct association with the Israeli Ministry of Health, and (4) exploring the use of MDMA-assisted psychotherapy in other cultural contexts.

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April 4, 2014

Social Anxiety in Autistic Adults: First Potential Subject Screened; Website Launched

On April 4, 2014, screening took place for the first potential subject in our new study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum. On March 26, we officially launched mdma-autism.org, an all-new website with background on the goals of the study, plus educational resources about autism, social anxiety, and MDMA-assisted therapy. Adults on the autism spectrum often face social adaptability challenges and greater anxiety, depression, and victimization than typically developing adults. The study is the latest in our expanding program of research into the therapeutic use of MDMA. Our $100,000 grant application to Autism Speaks was rejected on April 4.

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April 4, 2014

Therapist Training: Four Subjects Receive MDMA-Assisted Psychotherapy

Between March 24 and April 4, 2014, four additional subjects received MDMA-assisted psychotherapy in our ongoing therapist training study in Charleston, SC. This protocol was designed as a Phase 1 study of the safety and psychological effects of MDMA-assisted psychotherapy in healthy volunteers, with subjects limited to therapists in training to work on a MAPS-sponsored MDMA-assisted psychotherapy study. Two of the subjects enrolled are therapists in our ongoing study in Boulder, Colorado, and two are affiliates of the U.S. Veterans Affairs National Center for PTSD Researchi training for a possible collaborative VA/MAPS study, with funding offered from MAPS. During these sessions, an additional night attendant affiliated with the VA was also trained.

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March 27, 2014
  Los Angeles Biomedical Research Institute and MAPS "PRESS RELEASE: Study Initiated Exploring MDMA-Assisted Therapy for Social Anxiety in Autistic Adults" .

Seeking new therapies for the treatment of social anxiety in autistic adults, researchers at the Los Angeles Biomedical Research Institute (LA BioMed) announced today that they are initiating a novel study into the safety and effectiveness of MDMA-assisted therapy. The study is the latest in an expanding program of research into the therapeutic use of MDMA by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS). The research seeks to examine effective treatments for adults on the autism spectrum, who often face social adaptability challenges and greater anxiety, depression, and victimization than typically developing adults.

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March 9, 2014

Boulder: Fifth Subject Treated, Sixth Subject Enrolled

On February 7 and March 9, 2014, the fifth subject was treated in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. This study is investigating the safety and effectiveness of MDMA-assisted psychotherapy for 17 subjects with chronic, treatment-resistant PTSD resulting from sexual assault, violent crime, war, or any other cause. The sixth subject was enrolled on March 1. Our goals for this Phase 2 study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted psychotherapy for subjects with PTSD from a variety of causes, (2) comparing different doses of MDMA for therapeutic effectiveness and ability to create a successful double-blind, (3) exploring whether using intern co-therapists can reduce costs while maintaining treatment effectiveness, and (4) training the next generation of psychedelic psychotherapists.

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February 21, 2014

U.S. Veterans: 15th and 16th Subjects Treated with MDMA-Assisted Psychotherapy

On February 21, 2014, the 15th subject was treated in our ongoing study in 24 U.S. veterans, fire fighters, and police officers with chronic, treatment-resistant PTSD. The 16th subject was enrolled on February 17, and received their first MDMA-assisted psychotherapy treatment on February 24. Both of these subjects have also enrolled in our new physiological effects sub-study, which will measure the physiological effects of MDMA-assisted psychotherapy using heart rate variability (HRV) and functional magnetic resonance imaging (fMRI) and explore correlations with clinical outcomes.

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February 14, 2014

Canada: Institutional Review Board Approves Protocol Amendment

On February 14, 2014, the Institutional Review Board approved an amendment to our ongoing Canadian study of MDMA-assisted psychotherapy for PTSD. The amended protocol, which includes changes to the MDMA dose condition, was submitted to Health Canada for review on February 14, and to the U.S. Food and Drug Administration on February 6. Subjects are now being screened for this study.

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February 10, 2014

Social Anxiety in Autistic Adults: Study Initiation Takes Place at LA Biomedical Research Institute

From February 7-10, 2014, the official study initiation visit for our new study of MDMA-assisted therapy for social anxiety in autistic adults took place at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. MAPS Clinical Research Scientist Berra Yazar-Klosinski, Ph.D., and Clinical Study Assistant Ben Shechet met with the research team, conducted a thorough review of the protocol and subject informed consent forms, conducted a compounding and encapsulation training with the research pharmacy, evaluated the study facilities, helped set up the treatment room, and met with site staff. Led by Charles Grob, M.D., and Alicia Danforth, Ph.D., the goal of this study is to enhance functional skills in autistic adults, an underserved group which tends to experience greater anxiety, depression, and victimization than typically developing adults.

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January 29, 2014

U.S. Veterans: 15th Subject Enrolled; Brain Imaging and Heart Rate Sub-Study Starts

On January 29, the 15th subject was enrolled in our ongoing study in 24 U.S. veterans, fire fighters, and police officers with chronic, treatment-resistant PTSD. This will also be the first subject enrolled in our new brain imaging and heart rate sub-study, which will use heart rate variability (HRV) and functional magnetic resonance imaging (fMRI) to measure the physiological effects of MDMA-assisted psychotherapy and explore correlations between those effects and clinical outcomes. Nine subjects have now completed the study following their one-year follow-up. The regularly scheduled site monitoring visit was completed from January 17-20. As of January 31, the site had received 496 participation inquiries.

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January 22, 2014

Boulder: Fifth Subject Enrolled; MDMA Encapsulated for New Dose Group

On January 22, the fifth subject was enrolled in our ongoing study of MDMA-assisted psychotherapy for PTSD taking place in Boulder, Colorado. (Note: We are now subtracting dropouts from the total number of subjects treated to more accurately reflect study progress.) The fourth subject received their second experimental treatment on January 17. The second subject, who dropped out after one treatment session due to scheduling difficulties despite feeling improved, has agreed to return for her one-year follow-up. On January 21, the MDMA was encapsulated for the new 100 mg dose group and for Stage 2 of the study protocol. Led by Principal Investigator Marcela Ot’alora, this study will treat 17 subjects with chronic, treatment-resistant PTSD resulting from sexual assault, military service, violent crime, or other causes. As of January 31, we have received 214 inquiries for participation in this study.

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January 13, 2014

DEA Approves Schedule I License for Study Pharmacy; Initiation Scheduled

On January 13, 2014, Principal Investigator Charles Grob, M.D., received from the U.S. Drug Enforcement Administration the Schedule I pharmacy license for our new study of MDMA-assisted therapy for social anxiety in autistic adults. The license was issued on December 27, 2013. With this final regulatory permission in hand, Dr. Grob and co-investigator Alicia Danforth, Ph.D., are now creating the initial waiting list. The official study initiation is scheduled to take place from February 7-10, and the MDMA for the study will be encapsulated in mid-February.

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January 7, 2014

Israel: Site Monitoring Visit Completed

On January 7, 2014, MAPS Clinical Research Associate Mimi Peleg completed the regularly scheduled site monitoring visit for our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD. The study is taking place at Beer Ya’akov Mental Hospital in Israel, and is led by Principal Investigator Moshe Kotler, M.D.

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MAPS-Sponsored Clinical Trials: MDMA-Assisted Psychotherapy for PTSD

contract U.S. Proof of Principle (Completed)

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’ "proof of principle" 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.

On July 19, 2010, the results of this study were published in the Journal of Psychopharmacology. Our paper was the journal's most downloaded article in 2010.

On July 27, 2010, data collection was completed for the long-term follow-up to this study. We collected Clinician-Administered PTSD Scale (CAPS) measurements from 17 of the 20 subjects who received treatment. All 20 subjects filled out a questionnaire developed internally to assess long-term effects. The average length of time between the final experimental treatment session and the follow-up data collection was 3½ years. On November 20, 2012, the paper describing the long-term follow-up results was published in the Journal of Psychopharmacology. The long-term follow-up found that the benefits persisted over time, though a few subjects had relapsed due to new life stressors.

The study has cost $1,200,000; all of which has been raised.

View the timeline for this study.

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contract U.S. Veterans (Ongoing)

A Randomized Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans with Chronic Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Michael Mithoefer, M.D., with co-therapist Annie Mithoefer, B.S.N.
Location: Charleston, SC (USA)

This pilot Phase 2 study is examining the safety and efficacy of MDMA-assisted psychotherapy in 24 veterans, firefighter, and police officers with service-related PTSD. We are seeking equal numbers of male and female subjects. This protocol is randomized and triple-blind. All subjects will receive weekly non-drug psychotherapy and three experimental day-long therapy sessions, scheduled three to five weeks apart. We are testing three different doses of MDMA to determine whether this design will result in a successful blind, with subjects, therapists, and the independent rater being uncertain about which subject received which dose. 12 subjects will receive a full 125 mg dose followed by a 62.5 mg supplemental dose; six subjects will receive an active dose of 75 mg followed by a supplemental 37.5 mg dose; and six subjects will receive an active placebo dose of 30 mg followed by a supplemental 15 mg dose.

Our exploratory sub-study of the mechanisms of action of MDMA-assisted psychotherapy for PTSD (which was approved by the Copernicus Institutional Review Board on December 3, 2013) will enroll subjects from this study. We will use heart rate variability (HRV) and functional magnetic resonance imaging (fMRI) to measure the physiological effects of MDMA-assisted psychotherapy and explore correlations between those effects and clinical outcomes. Our goals for this study are to contribute to the evidence base for MDMA-assisted psychotherapy, add to existing knowledge about the physiological correlates of PTSD, identify therapeutic processes within our treatment method, and gather preliminary data for a grant application to the National Institute of Mental Health (NIMH). The sub-study will be conducted in collaboration with researchers at the Medical University of South Carolina (MUSC), Smith College, and the New School for Social Research.

The findings of this study in veterans with war-related trauma will be compared to the findings from our flagship pilot study of MDMA-assisted psychotherapy for PTSD, 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 this study may help establish the relationship between trauma etiology and treatment efficacy.

We are currently seeking research participants for this study. Please visit our participate in research page for more information.

Download the protocol for this study.

$1,380,000 estimated study cost • $1,330,000 raised • $50,000 still needed

Please consider donating today to help this study.

View the timeline for this study.


Timeline Overview

December 23, 2009: We submitted our Investigational New Drug (IND) application to the FDA.

February 1, 2010: Our FDA IND application was approved with no changes required.

April 1, 2010: FDA accepted the first amendment to our Veterans of War Protocol.

August 27, 2010: The Drug Enforcement Administration (DEA) informed Clinical Investigator Michael Mithoefer, M.D., that it had approved his Schedule 1 license.

August 31, 2010: The second protocol amendment was submitted to the IRB, and approved on September 20.

September 30, 2010: The second protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.

August 2, 2011: The third protocol amendment was submitted to the IRB, and approved on August 11.

August 4, 2011: The third protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.

February 10, 2012: The fourth protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.

February 14, 2012: The fourth protocol amendment was submitted to the IRB, and approved on February 22.

December 3, 2013: The protocol for our sub-study of the mechanisms of action of MDMA-assisted psychotherapy was approved by the Copernicus IRB

Data management provided by

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contract U.S. Relapse (Completed)

MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Relapse Study

An Open-Label Proof-of-Principle Study Testing the Use of an Additional MDMA-Assisted Psychotherapy Session in People who Relapsed after Participating in a Phase 2 Clinical Trial of MDMA-Assisted Psychotherapy to Treat Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Clinical Investigator: Michael Mithoefer, M.D.
Location: Charleston, SC

This study enrolled three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. This relapse study will attempt to determine whether a single additional open-label MDMA-assisted psychotherapy session along with several non-drug psychotherapy sessions can be effective for once again enabling these subjects to be free of a diagnosis of PTSD.

This study has full approval from an Institutional Review Board (IRB), the U.S. Food and Drug Administration (FDA), and the U.S. Drug Enforcement Administration (DEA). All three subjects have been treated, and follow-up interviews are continuing to take place.

$55,000 needed to complete this study
Please consider donating today to help this study.

View the timeline for this study.

Data management provided by

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contract U.S. Boulder, Colorado (Ongoing)

The next phase (Phase 3) of our clinical development plan for MDMA-assisted psychotherapy for PTSD will require many more male/female co-therapist teams than are currently available. Finding a cost-effective and sustainable way to recruit effective therapists is therefore a top priority.

In this pilot study, we are investigating the effectiveness of MDMA-assisted psychotherapy for PTSD when one member of the standard male/female co-therapist team is a healthcare intern (being trained in therapy, social work, or nursing). The other member of the team will be a professional therapist trained in our treatment method. As interns work for free in exchange for fulfilling required training hours under professional supervision, this approach would reduce costs and train the next generation of psychedelic therapists.

Principal Investigator: Marcela Ot'alora, M.A., L.P.C.
Location: Boulder, CO

Subjects will be U.S. veterans with PTSD, mostly from Iraq, Afghanistan, or Vietnam, along with survivors of childhood sexual abuse, assault, rape, and others.

This study has been cleared by the Food and Drug Administration and approved by the Drug Enforcement Administration and an Institutional Review Board.

$711,000 estimated study cost • $213,000 raised • $498,000 still needed

Please consider donating today to help this study.

Data management provided by

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contract Australia (Under Development)

Australian Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder

This study will evaluate the safety and effectiveness of MDMA-assisted psychotherapy in 12 subjects with chronic, treatment-resistant PTSD. It will compare the effectiveness of two dosages of MDMA in combination with psychotherapy: a full dose of 125mg (with a supplemental 62.5mg) and a low dose of 30mg (with a supplemental 15mg). Seven subjects will be allocated to the full dose condition, with the remaining five to the low dose condition. Subjects in this study will receive two experimental sessions instead of three, enabling us to compare the results with our other studies and helping us to determine whether two or three sessions is more efficient for use in our Phase 3 studies.

This study is in the protocol approval stage.

View the timeline for this study.

$50,000 needed / additional funds provided by co-sponsor


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contract Canada (Ongoing)

Principal Investigator: Ingrid Pacey, MD
Location: Vancouver, BC (Canada)

This study has full approval from an Institutional Review Board (IRB), Health Canada, and the U.S. FDA. Data will also be submitted to the FDA under IND #63,384.

An amended protocol was approved by the Institutional Review Board on July 12, 2013, and by Health Canada on September 6, 2013. This study is now screening subjects.

Psychiatrist Ingrid Pacey, M.D., a distinguished Holotropic Breathwork facilitator, is the Principal Investigator leading the study.

$419,000 estimated study cost • $44,000 raised + $3,500 raised by partners • $371,500 still needed

Please consider donating today to help this study.

Learn more about psychedelic research in Canada at mapscanada.org.


Site Team

Dr. Ingrid Pacey, MBBS, FRCP(C), Principal Investigator, Co-therapist

Dr. Ingrid Pacey comes from a Lithuanian family which migrated to Australia in 1949. She came to Canada in 1967 after completing medical school at the University of New South Wales, Sydney, Australia. She received her psychiatric training at the University of British Columbia, Vancouver, graduating in 1972. While in medical school, she witnessed LSD psychotherapy in a psychiatric setting as part of her training. Her private practice in Vancouver became focused on psychotherapy for trauma survivors, particularly women who had been sexually abused as children. From 1987 - 1990, she trained with Dr. Stanislav and Christina Grof in Holotropic Breathwork. Over the next 14 years, she went on to pioneer the use of Holotropic Breathwork with trauma survivors, observing the special needs of people with PTSD when working in Holotropic Breathwork groups. Through this work she came to see the value of working with non-ordinary states of consciousness for people suffering from PTSD. Dr. Pacey continues to practice psychiatry in Vancouver, and she has lectured in Canada and the US.

Video: Ingrid Pacey on MDMA-assisted psychotherapy for PTSD.

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contract Israel (Ongoing)

Principal Investigator: Moshe Kotler, M.D.
Study Site: Beer Ya’akov Mental Hospital, Israel

This study has the approval of the Israeli Ministry of Health, an independent Ethics Committee, and the U.S. Food and Drug Administration.

On January 10, 2011, our clinical team submitted the documents detailing our new protocol for our new Israeli study of MDMA-assisted psychotherapy for PTSD to the Institutional Review Board (IRB) at Beer Yaakov, Israel. On January 19, 2011, the ethics committee approved the protocol.

This study has been initiated, and is monitored by local Clinical Research Associate Mimi Peleg.

The first subject was treated on April 17, 2013. This study is currently ongoing.

The Israeli Defense Forces will refer soldiers with war-related PTSD to facilitate recruitment for the study.

$493,000 estimated study cost • $83,000 raised • $410,000 still needed

Please donate now to help complete this study.

Israeli donors can contribute directly to the study by sending a check or note to Benefesh Hafetza (The Hospital Friends Association), PO Box 1, Beer Ya'acov, Israel, and specifying that the donation is for "MAPS MP-9". Please contact .(JavaScript must be enabled to view this email address) when making your donation so we may thank you for your contribution.

View the timeline for this study.

We closed our first Israeli MDMA/PTSD study on March 26, 2010, in order to provide more training to the therapeutic teams and to our independent rater, to improve our data collection processes, and to make several improvements to the protocol. There were no Serious Adverse Events (SAEs) and all patients had been treated without evidence of harm. We have reviewed the data from the five subjects who were treated and found self-reports of healing, but quantitative measures did not correspond.


Monitoring Team

Mimi Peleg, Clinical Research Associate

Mimi earned her BA in Sociology from U.C. Berkeley in 1993 where she focused on quantification and organizational sociology. In Israel she has worked for both HP and Check Point in the field of security. She is currently a Contract CRA for the MAPS MDMA/PTSD study at Beer Yackov and the Director of Large Scale Cannabis Training for MECHKAR, Arbarbanel Hospital Bat Yam. Prior to moving to Israel she held computing positions at the University of California, Santa Cruz and the Wo/Men's Alliance for Medical Marijuana. She is co-author (with the late Robert Anton Wilson) of Everything Is Under Control: Conspiracies, Cults, and Cover-Ups.


Site Team

Moshe Kotler, M.D., Principal Investigator

Born Tel Aviv 1949, Dr. Kotler received his medical education at the Hadassah and Hebrew University Medical School in Jerusalem earning his M.D. in 1976. He completed his residency in psychiatry in 1985 at the TAU-affiliated Shalvata Mental Health Center in Hod Hasharon, Israel. He served as the Chief Psychiatrist of the IDF from 1985-1989 followed by a Fellowship in Biological Psychiatry and Psychopharmacology at the Albert Einstein College of Medicine, New York. Subsequently he served as the Director of the outpatient division of psychiatry in Sheba Medical Center, Ramat Gan, Israel, as well as the Director of the Beer Sheva Mental Health Center, a major teaching hospital of Ben Gurion University where he served as the Chairman of the Department of Psychiatry and Vice Dean of Medical Education at the Ben Gurion Medical Faculty of Medicine. Since 1997, he heads the combined institutions of Beer Yaakov and Ness Ziona Mental Heath Centers. Between years of 2004 and 2006 he served as the Chairman of Psychiatry at the Sackler Faculty of Medicine at TAU. Dr. Kotler is the current Chairman of the Israeli National Council for Mental Heath.

Daniel Dogon, M.A. (Social Work), Clinical Investigator

Received his M.A. from Ben Gurion University in Social Work specializing in integrating Artistic and Creative tools. Daniel comes from a Gestalt and Jungian psychotherapy orientation. For over 20 years he has been a Buddhist Therapist and a Senior Instructor of Chinese medicine and Philosophy at the Tmurot (Israeli Integrated Medicine School). Daniel practices Integrative Psychotherapy combining working with the body as a living presence in the here and now of the session—a combination that allows access to the heart of the difficulty and opens the door for change from experience(s). In his spare time Daniel enjoys his baby son and his dog. He lives in rural Pardes Hanna, and dabbles in clay, gardening, cinema and hiking.

Naftali Halberstadt, Ph.D., Clinical Investigator

Ph.D. in Cognitive Psychology from the Hebrew University of Jerusalem; Senior CBT therapist and supervisor for treatment of PTSD. Developed and directed the Psycho-Trauma Response Program for The American Jewish Joint Distribution Committee (AJJDC) in Israel from 2002-2008. From 2008-2012, he was director of the Training Center for Mind-Body Skills, closely associated with the U.S-based Center for Mind-Body Medicine (CMBM). Naftali is a member of the CMBM International Training Faculty. International humanitarian relief is central to Naftali’s professional identity. In 2005, he was part of an Israeli team of trauma experts sent to train professionals in Sri Lanka in the aftermath of the Tsunami disaster. He consulted to professionals in the aftermath of the Katrina hurricane disaster. In 2010 he was part of a team of mental health experts organized by the Israel Trauma Coalition to train professionals in Haiti. He had returned repeatedly to Haiti as part of the CMBM relief and training efforts there. In 2012, Naftali was asked to join a USAID-funded, AJJDC project to develop psycho-social disaster readiness in Indonesia.

Tali Nachshoni, M.D., Clinical Investigator

Since 1988, Tali Nachshoni, M.D., psychiatrist and psychotherapist, has treated a wide range of mainly adults with issues such as: affective disorders, psychotic disorders, anxiety disorders including PTSD and recently complex PTSD with dissociative features, personality disorders and comorbidities and a large variety of other mental health issues. Most of Tali's work is on-site at Beer Yaacov in the Partial Hospitalization unit where she serves as a Senior Psychiatrist. Off work, Tali is a wife and mother of 2 adult children, and she balances her work by being an avid movie goer, music lover (all kinds), ballroom dancer and traveler and snorkeler all over the world.



Keren Tzarfaty, M.A., Ph.D.(c), Clinical Investigator

Keren Tzarfaty, M.A., Ph.D(c) in East-West Psychology from the California Institute of Integral Studies (CIIS), works with a wide range of people seeking healing and psychospiritual growth. In her work she addresses relationship challenges, anxiety, depression, PTSD, and works to help clients manifest their potential and live life fully. Keren is a certified Hakomi teacher and, together with Ido Siemion, co-founder of the Hakomi Institute of Israel. Hakomi is a mindfulness based method of depth psychotherapy. In her work, she draws upon her knowledge in Psychodynamics and Humanistic Psychology, Eastern spiritual traditions, East-West Psychology, Shamanic traditions, and her own life experience as a woman, partner, and mother of two young children.

Dafna Bornstein-Lavi, L.Ac, Study Coordinator

Dafna is an Acupuncturist and Holistic Therapist specializing in Korean Medicine, Yoga Therapy, and many kinds of massage. She has a private clinic in Tel Aviv, and works for Kupat-Holim Clalit and Holmes-Place Spa, previously working at Reut Hospital and Neve-Tzedek Spa. In the past she was a project manager, specializing in software localization and QA, Office manager, and Air Force Intelligence office. She has a B.A. in Philosophy and General Studies from Tel-Aviv University and hopes to finish her M.A. in Jewish Philosophy some day. She enjoys reading, Yoga, and juggling.



Anne-Marie Ulman, M.D., Independent Rater

Anne-Marie Ulman, originally from Paris, France studied at the Pitie-Salpetriere Medical school, Paris, France and has served as Senior psychiatrist in Beer Yaakov Mental Center since 1995. She began in the close acute ward and since 2004 she practices in a chronic/rehabilitation ward as a Senior Psychiatrist specializing in Rehabilitation Psychiatry, since 2006 has been a member of the hospital "Rehabilitation Basket" commission. She also specializes in Ethnocultural consultations at the out-patient clinic and is in charge of Cultural and Linguistic Adaptation and Accessibility of Hospital services at Beer Yaakov. She was involved in a pilot study (funded by the Israel National Institute for Health Policy) on suicide prevention, which is an acute problem among people of Ethiopian origin in Israel. This study explores the place of cultural factors in diagnosis, treatment and prevention of suicidal behaviors. Anne-Marie is also teaching medical students and residents. In her private life Anne-Marie resides in Tel Aviv with her daughter and red-haired cat and until today remains fascinated by the study of identity.

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contract Jordan (Rejected)
MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Nasser Shuriquie, M.D. and TBD
Location: Amman, Jordan

This study has been rejected by the Jordanian Food and Drug Administration (JFDA). MAPS will work with researchers to obtain government approval for this study when we begin planning for Phase 3 of our MDMA-assisted psychotherapy for PTSD development program. We hope to enroll Iraqi refugees living in Jordan who have PTSD, along with other Jordanians suffering from PTSD.

View the timeline for this study.


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contract Spain (Concluded)

Spanish Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (Concluded)

Started in 2000, this study was the world's first clinical trial to evaluate the safety and effectiveness of MDMA-assisted psychotherapy. This dose-response study, in 29 women with chronic, treatment-resistant PTSD caused by rape or childhood sexual abuse, was designed to compare the effectiveness of five dosages of MDMA in combination with psychotherapy: 50 mg, 75 mg, 100 mg, 125 mg, 150 mg. Six of the 29 subjects were treated before pressure from the Madrid Anti-Drug Authority led to the revocation of permission to use the study site. As of May 13, 2002, when the study was shut down for political reasons, we had completed treating four patients in the 50 mg dose group (three patients received 50 mg and one received a placebo), and two people in the 75 mg dose group (one patient received 75 mg and one received a placebo)

Principal Investigator: José Carlos Bouso, PhD
Location: Madrid, Spain

May 11, 1999: Study protocol approved by the Research Committee of the Hospital Psiquiátrico de Madrid
July 16, 1999: Study protocol approved by the Ethics Committee of the Hospital Universitario La Paz
February 7, 2000: Study approved by the Spanish Agency for Medicines and Health Products
March 2002: Spanish anti-Ecstasy campaign
May 13, 2002: Hospital Psiquiåtrico de Madrid revokes permission to use facilities
May 23, 2002: Study concluded

View the complete timeline for this study.


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contract Switzerland (Completed)

MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)
Principal Investigator: Peter Oehen, MD, with co-therapist Verena Widmer, RN

Location: Solothurn, Switzerland

All data gathering has been completed and the results are being written up for publication. All 12 subjects with treatment-resistant PTSD have undergone the experimental treatment. The final subject's last visit took place on January 8, 2010. The final analysis was completed in January 2011, after the last measurements for the one-year, long-term follow-up phase of the study were collected from the final subject. The results will be published February 2013 in the Journal of Psychopharmacology.

Our Swiss MDMA/PTSD pilot study had full approval from an Ethics Committee (Swiss IRB equivalent) and SwissMedic (FDA equivalent). The protocol had also been submitted to, and accepted by, the FDA under MAPS’ Investigational New Drug (IND) application for MDMA. The study is a part of MAPS’ clinical plan to develop MDMA into a prescription medicine approved by both the FDA and the European Medicines’ Agency (EMEA).

View the timeline for this study.


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contract Training Protocol for Researchers (Ongoing)
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. On December 21, 2009, we received IRB approval. On August 9, 2010, Dr. Mithoefer received his Schedule 1 license from the DEA to administer MDMA in this study.

Therapist Training Protocol/Phase 1 Psychological Effects: Amendment 2 approved by IRB 12/21/09 (PDF)

$472,000 needed • $2,000 raised • $470,000 still needed
Please consider donating today.

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More MAPS-Sponsored Clinical Trials

contract MDMA-Assisted Psychotherapy for Anxiety Secondary to Advanced Stage Cancer (Concluded)

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 was also being conducted under US FDA IND and has received IRB approval and DEA registration.

One subject completed the experimental treatment. A second subject participated in the first of two experimental sessions before dropping out due to a decision to resume chemotherapy, which required them to drop out since the study was only for people who were receiving only palliative treatments. No additional subjects were enrolled and the study was closed due to enrollment challenges.

Protocol submitted to FDA on November 26, 2004 (in HTML or PDF format)


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contract MDMA-Assisted Therapy for the Treatment of Social Anxiety in Autistic Adults

Learn more at mdma-autism.org.

Autism is a genetically based human neurological variant. Autism is a developmental phenomenon, meaning that it begins in utero and has a pervasive influence on multiple levels of development throughout the lifespan. Autistic individuals frequently experience difficulty in the realm of social interaction. Comparative studies suggest that autistic adults, especially those who are verbal and whose autism might not be immediately recognizable to others and who are faced with strong pressure to conform to non-autistic social norms, are at greater risk for lifetime and current psychological disorders, especially social anxiety.

There are currently no FDA-approved pharmacological treatments for autistic adults with social anxiety, and conventional anti-anxiety medications lack clinical effectiveness in this population. Based on anecdotal reports, MDMA-assisted therapy may be a suitable intervention for the treatment of social anxiety in autistic adults and warrants further investigation in a randomized controlled clinical trial.

MAPS is sponsoring a randomized, double-blind, placebo-controlled exploratory pilot study with dose escalation to assess the safety and feasibility of MDMA-assisted therapy to treat social anxiety in 12 MDMA-naïve adults on the autism spectrum. This study will also obtain estimates of effect size based on two experimental MDMA-assisted therapy sessions in comparison to an inactive placebo control group. If the results warrant further investigation, data from this study will be used to design additional studies.

In affiliation with

Charles Grob, M.D., and Alicia Danforth, Ph.D.(c), will be co-investigators for this study.

MAPS is sponsoring this collaborative study between the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and Stanford University.

Subjects will be autistic adults with social anxiety, age 21 and older, who have completed two years of college-level education or comparable vocational training.

February 28, 2013: Protocol submitted for review by the U.S. Food and Drug Administration
July 18, 2013: Protocol approved by the U.S. Food and Drug Administration
October 16, 2013: Protocol approved by the Institutional Review Board

$340,000 estimated study cost • $1,000 raised + $15,000 raised by partners • $324,000 still needed

Please consider donating today to help complete this study.

View the complete timeline for this study.

Learn more at mdma-autism.org.


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Auxiliary MAPS-Sponsored MDMA Projects

contract Manual for MDMA-Assisted Psychotherapy in the Treatment of PTSD

Contributors: Annie Mithoefer, B.S.N., Lisa Jerome, Ph.D., June Ruse, Psy.D., Rick Doblin, Ph.D., Elizabeth Gibson, M.S., Marcela Ot'alora G., L.P.C.

The Multidisciplinary Association for Psychedelic Studies (MAPS) is sponsoring clinical trials to explore the potential risks and benefits of 3,4-methylenedioxy-N-methylamphetamine (MDMA)-assisted psychotherapy in chronic posttraumatic stress disorder (PTSD) participants.

This manual provides researchers with a method of MDMA-assisted psychotherapy to be used as a model in conducting these trials. This manual is intended only for use with subjects of an approved clinical trial who have provided their informed consent.


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MDMA Literature, History, Testimonials, Risks

contract MDMA Investigator's Brochure and FDA Annual Report

MDMA Investigator's Brochure

Our Investigator’s Brochure for MDMA researchers describes the physical, chemical, and pharmacological characteristics of MDMA, its effects in nonclinical and clinical studies, and the safety profile of MDMA-assisted psychotherapy. This brochure focuses on research and information relevant to researchers and regulators engaged in clinical trials with MDMA.

FDA Annual Report on MDMA

This annual report covers the period from October 2, 2011 through October 1, 2012, and provides a cumulative listing of all studies using MDMA under MAPS’ US IND #63,384.


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contract MDMA Scientific Literature, Government Hearings, and Archive
Scientific Literature Reviews
Ricaurte MDMA Research Controversy
Government Hearings and Conferences
Media Reports
 A MAPS History of MDMA

MDMA was synthesized in 1912 and patented in Germany by Merck in 1914 but was not the subject of human research at that time. In the 1950s it was briefly researched by the U.S. Government as part of the CIA’s and the Army’s chemical warfare investigations. It was forgotten until the middle 1970s when it was rediscovered by the psychedelic therapy community and began to be used as an adjunct to psychotherapy by psychiatrists and therapists who were familiar with the field of psychedelic psychotherapy. MAPS published a book, The Secret Chief, about the leader of this therapy community.

In the early 1980s, the drug began to be used non-medically, particularly in Texas, under the name Ecstasy. Both the non-medical and therapeutic use of MDMA were made illegal in 1985 despite the Drug Enforcement Administration Administrative Law Judge Francis Young’s recommendation that physicians be permitted to continue to administer it to their patients. Rick Doblin, Alise Agar and Debby Harlow helped coordinate the pro-MDMA contingent in the DEA lawsuit. For an excellent history of the early use of MDMA, see Pursuit of Ecstasy by Beck and Rosenbaum.

In 1986, with the goal of developing MDMA’s therapeutic potential through FDA-approved protocols, Rick Doblin founded MAPS as a non-profit research and educational organization with the mission to act as a psychedelic and medical marijuana pharmaceutical company. MAPS immediately opened a Drug Master File for MDMA with data gathered from the standard preclinical animal toxicity studies required by FDA . Subsequently, five different applications for permission to conduct human research with MDMA were submitted to FDA between 1986 to 1988, to the Neuropharmacologic Drug Products Division directed by Dr. Paul Leber.

All five applications were rejected. Three protocols for double-blind controlled trials were from researchers at, respectively, Harvard Medical School, UC San Francisco Medical School, and U. of New Mexico Medical School, and were all rejected. Two applications submitted by individual physicians were for single case studies, one for a terminal cancer patient who had been successfully treated for pain with MDMA-assisted psychotherapy prior to the criminalization of MDMA and the other for a unipolar depression patient for whom all available treatments had been attempted without success. Both of these single-patient INDs were also rejected.

The FDA based its rationale for rejecting all protocols and single case studies on the hypothetical risk of functional consequences of potential neurotoxicity from MDMA. MDMA research claimed that the rejection of all efforts to conduct FDA-approved MDMA research was based not on rational risk/benefit assessments but on an underlying cultural prejudice against medical research with drugs that were criminalized and on one or more FDA officials’ personal opposition to human research with psychedelics.

Since FDA Review Divisions are sometimes described as operating like fiefdoms under the control of their Directors, proponents felt profoundly stymied. Proponents claimed that concerns about MDMA neurotoxicity, which numerous studies had failed to link with functional or behavioral consequence and which in any case had not been clearly demonstrated to occur at all at therapeutic does levels, were reminiscent of scientific research in the 1960s that claimed to prove that LSD damaged chromosomes. These reports were effective in generating public disapproval of LSD and in hindering research but were later determined to have no clinically significant effect.

MAPS continued to fund animal toxicity studies at Stanford (1986-1988) and human safety studies at Stanford and Johns Hopkins (1988-1991). In 1992, FDA reviewed a MAPS-supported protocol submitted by Dr. Charles Grob, then at UC Irvine, for a study of the use of MDMA in the treatment of pain, anxiety and depression in cancer patients. FDA’s Drug Abuse Advisory Committee recommended that the cancer patient study be postponed and that a Phase 1 dose-response safety study be conducted first. The protocol was redesigned, with FDA giving final approval for the Phase 1 safety study on November 5, 1992. The safety study was completed in 1995.

Data from the safety study revealed no unusual risks and indicated that MDMA could be safely administered within a clinical research context. Dr. Grob submitted the first draft of the protocol for the study of cancer patients in 1997. Negotiations with FDA moved very slowly, due to initial FDA decisions to put MDMA psychotherapy research on a slow track to nowhere.

However, FDA opposition eventually lessened as MAPS and Dr. Grob persisted in our efforts to obtain permission for research into the use of MDMA-assisted psychotherapy in cancer patients. A July 24, 1999 teleconference with the FDA concerning MDMA psychotherapy research to treat anxiety, depression and pain in cancer patients went very well, with the FDA indicating a willingness to approve "proof of principle" study. Unfortunately, Dr. Grob’s other work-related responsibilities made it difficult for him to find the time to work on the approval process for this research project.

On March 18, 2000, Rick Doblin and Michael Mithoefer met at an ayahuasca conference in San Francisco, sponsored by Ralph Metzner, and begin talking about conducting MDMA psychotherapy research in the US. This marks the beginning of their effort to study subjects with chronic posttraumatic stress disorder. On November 9, 2000, the first subject is treated in Jose Carlos Bouso’s MAPS-sponsored MDMA/PTSD study in Madrid, Spain. On May 13, 2002, the Spain MDMA/PTSD study gets shut down due to political pressure, after six subjects have been enrolled in the study without any persisting adverse effects.

Dr. Grob subsequently decided to focus on the use of psilocybin, instead of MDMA, in cancer patients, on the accurate theory that psilocybin research would be less controversial than MDMA research. In June 2003, MAPS starts formally working with Dr. John Halpern, McLean Hospital, Harvard Medical School, on the design of a study administering MDMA-assisted psychotherapy to end-stage cancer patients. Late in 2003, Dr. Grob managed to obtain approval for his psilocybin/cancer patient study.


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contract Accounts of MDMA’s Healing Effects

PTSD

Meditation and PTSD

Cancer and Life-Threatening Illness

Bipolar Disorder

Couples Therapy

Chronic Pain

Eating Disorders

Family Relationships

Parkinson's Disease

Rheumatoid Arthritis

Spiritual, Emotional, and Other Therapeutic Accounts


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Other MDMA Resources

contract Resources on the MAPS Site

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contract Resources on Other Sites

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Give Our Veterans Hope
1 in 7 Iraq and Afghanistan veterans suffer from PTSD, in many cases leading to suicide. We owe it to our veterans to stop this epidemic.

Tell the Pentagon to fund MAPS' groundbreaking work to treat PTSD.

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