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.
MDMA is not the same as Ecstasy. Substances sold on the street under the name Ecstasy do often contain MDMA, but frequently also contain harmful adulterants. In laboratory studies, pure MDMA—but not Ecstasy—has been proven sufficiently safe for human consumption when taken a limited number of times in moderate doses.
MAPS is undertaking a 10 year, $15 million plan to make MDMA into an FDA-approved prescription medicine, 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, and because it is only administered a limited number of times, unlike most medications for mental illnesses which are often taken daily for years.
U.S. Veterans Study: 13th Subject Completes Experimental MDMA-Assisted Psychotherapy Sessions
On May 3, 2013, the 13th subject completed their second experimental MDMA-assisted psychotherapy session in our ongoing study for veterans, firefighters, and police officers with service-related PTSD. This subject is the second firefighter with chronic, treatment-resistant PTSD to be enrolled in this study, which will enroll 24 total subjects. Four subjects have now completed the study, including the long-term follow-up portion.
U.S. Boulder Study: DEA MDMA Order Forms Arrive at Study Site
On April 30, 2013, the DEA Schedule I Controlled Substance order forms arrived at the site for our upcoming study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. Receiving these forms from the DEA, which took two months, marks the end of the regulatory approval process since we have now ordered the MDMA and can soon initiate the study.
Social Anxiety in Autistic Adults: FDA Approves Protocol Design for New Study
On April 30, 2013, the U.S. Food and Drug Administration approved the protocol design for our pioneering study of MDMA-assisted therapy for social anxiety in autistic adults. The Advice Letter (pdf) from the FDA requested several changes to the exclusion criteria involving subject safety, some of which we thought were not necessary based on existing scientific literature. We have prepared an amended protocol incorporating some of these changes, along with evidence for why we don’t think the other changes are necessary. Once the FDA has reviewed and approved this amendment, we will submit the protocol and study materials for review by the Institutional Review Board at Harbor-UCLA Medical Center/LA Biomed. Charles Grob, M.D., and Alicia Danforth, Ph.D.(c), will be co-investigators for this study.
Israel: First Subject Completes Experimental MDMA-Assisted Psychotherapy Sessions
On April 17, 2013, the first subject was treated in our new Israeli study of MDMA-assisted psychotherapy for PTSD. This study will enroll 10 subjects with chronic, treatment-resistant PTSD, some of whom will be referred by the Israeli Defense Forces. This study is taking place at Beer Yaakov Mental Hospital, and is led by Principal Investigator Moshe Kotler, M.D.
Canada: Nine Grams of MDMA Arrive in Canada after Four-Year Delay
On April 16, 2013, the nine grams of MDMA to be used in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD arrived at the study pharmacy. Our efforts to start the study began in 2007, and we began seeking the import permit after Health Canada approved the protocol in March 2009. The Canadian pharmacist worked for more than 2½ years to make the security adjustments to the pharmacy required by Health Canada for the import permit. We are now preparing to submit a series of minor protocol amendments to Health Canada and to the Canadian Institutional Review Board. Once these amendments are approved, which could take several weeks to several months, we will begin screening and treating subjects.
Canada: MDMA Shipped from Switzerland to Canada After 2½-Year Delay
On April 8, 2013, the nine grams of MDMA to be used in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD were exported from Switzerland to Canada. The Canadian pharmacist worked for more than 2½ years to make the security adjustments to the pharmacy required by Health Canada for the import permit. MAPS’ efforts to design the protocol, receive all necessary approvals, and conduct the study began in 2007. Once the MDMA arrives at the study pharmacy after clearing customs, we will submit a series of minor protocol amendments to Health Canada and to the Canadian Institutional Review Board. Once the amendments are approved, which could take several weeks, we will begin screening and treating subjects.
U.S. Boulder Study: IRB Approves Amended Protocol; Site Prepares for Subject Screening
On April 5, 2013, an independent Institutional Review Board (IRB) approved the amended protocol and informed consent documents for our soon-to-be-initiated study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The amended protocol includes new study measures (the Dissociative Experience Scale II/DES-II and a Visual Analog Scale for Somatic Symptoms) and updated dosage information. We have also added additional study staff, including a new therapist and intern therapist. The FDA will now review the IRB-approved amended protocol while the site prepares to begin screening subjects.
Social Anxiety in Autistic Adults: Protocol Submitted to FDA
On February 28, 2013, the protocol (full protocol | synopsis) for our planned study of MDMA-assisted therapy for social anxiety in autistic adults was submitted to the U.S. Food and Drug Administration for review. This will be a MAPS-sponsored collaborative study between Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the Stanford University School of Medicine. Social anxiety is prevalent in autistic adults, and often compounds the considerable social challenges faced by autistic adults. The main objective of this study is to collect data on the safety of MDMA-assisted therapy in autistic adults, and to use standard clinical measures to estimate the extent to which MDMA-assisted therapy may reduce social anxiety symptoms in this group. Even though we did attempt to obtain external funding from a private foundation, our letter of intent was rejected. Please consider donating to help complete this study.
U.S. Boulder Study: DEA Approves Schedule I License for Study Physician
On February 21, 2013, the U.S. Drug Enforcement Administration approved the Schedule I license for the psychiatrist for our new study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The Schedule I license allows the study psychiatrist to store and administer the MDMA to be used in the study. The license was issued just one day after a favorable recommendation was sent to the DEA national headquarters by the agency’s Denver field office. We have now obtained all necessary approvals and can initiate the study months sooner than anticipated.
In contrast, we waited about five months for the DEA issue a Schedule I license to Dr. Michael Mithoefer, the lead investigator of our ongoing study in U.S. veterans, and seven months to issue his Schedule I license for our therapist training protocol. According to MAPS executive director Rick Doblin, Ph.D., “When DEA headquarters processes a Schedule I license for MDMA/PTSD research in just one day, anything seems possible.”
On February 13, 2013, our Canadian pharmacist received the corrected import permit from Health Canada, after working for more than 2½ years to make the required security adjustments to the pharmacy. The previous permit erroneously listed the manufacturer rather than the supplier on the form. Finally, after working more than three years, our Swiss MDMA supplier will now finally request an export permit.
On February 12, 2013, the first subject was enrolled in our new Israeli study of MDMA-assisted psychotherapy for PTSD. This study will enroll 10 subjects with chronic, treatment-resistant PTSD, some of whom will be referred by the Israeli Defence Forces. This study is taking place at Beer Ya’akov Mental Hospital, and is led by Principal Investigator Moshe Kotler, M.D.
U.S. Boulder Study: DEA Inspects Study Site for MDMA License
On February 6, 2013, field agents from the Denver, Colorado, office U.S. Drug Enforcement Administration inspected the site, safe, and alarm system that will protect the approximately eight grams of MDMA needed for our upcoming Boulder study of MDMA-assisted psychotherapy for PTSD. The agents’ report will be sent to DEA national headquarters, which will then review the report and decide whether to issue the Schedule I license to the study physician. Once the physician has received the license and the study drug, the site will begin recruiting and enrolling subjects.
Raters Trained to Evaluate Therapist Competence in MDMA-Assisted Psychotherapy
On January 23, 2013, MAPS coordinated an all-day training in San Francisco, Calif., for new adherence raters for our MDMA-assisted psychotherapy for PTSD research program. Adherence raters establish and assess therapist adherence to the Treatment Manual in conducting MDMA-assisted psychotherapy, in order to help assure data quality and standardization. Adherence raters are either licensed therapists or are in school or training to be licensed therapists. The training was led by lead adherence rater Evan Sola, M.A., MAPS Executive and Clinical Research Assistant Linnae Ponté, and MAPS Clinical Research Assistant Colin Hennigan. Download the Therapist Adherence and Competence Rating Manual…
On January 18, 2013, the 12th subject of 24 had their first experimental session in our ongoing study of MDMA-assisted psychotherapy for veterans, firefighters, and police officers with chronic, treatment-resistant PTSD. 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. This study is exploring whether the same treatment method can work for different causes of PTSD, as preliminary data suggests. As of January 30, we had received 388 inquiries about participation in the study, highlighting the extensive demand that exists for more effective treatments for PTSD.
Join Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., for a full-day workshop on Thursday, April 18 at Psychedelic Science 2013.
Israel: First Subject Completes In-Person Screening
On January 17, 2013, the first subject completed in-person screening for our new Israeli study of MDMA-assisted psychotherapy for PTSD, led by Principal Investigator Moshe Kotler, M.D., and monitored by Clinical Research Associate Mimi Peleg. This study has the approval of the Israeli Ministry of Health, the Ethics Committee at Beer Yaakov Mental Health Center, and the Israeli Anti-Drug Authority. The protocol has also been approved by the U.S. Food and Drug Administration, which reviews all of the data from our Phase 2 drug development program. The Israeli Defense Forces will refer soldiers with war-related PTSD to facilitate recruitment for the study.
On January 15, 2013, MAPS submitted our MDMA Annual Report to the U.S. Food and Drug Administration. Annual reports give the FDA an overview of completed, ongoing, and planned studies for specific Investigational New Drug (IND) Applications. This report covers the period from October 2, 2011 through October 1, 2012, and provides a cumulative listing of all studies using MDMA under our U.S. IND #63,384, including a comprehensive analysis of MDMA’s risk/benefit profile when used in psychotherapy for PTSD. Download the MDMA Annual Report…
Canada: Health Canada Grants Permission to Store and Administer MDMA
On January 10, 2013, Co-Principal Investigator Ingrid Pacey, M.D., received authorization from Health Canada to store and administer the MDMA to be used in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD. The site is now waiting to receive the MDMA import license from Health Canada, the MDMA will be imported from Switzerland, where it is currently stored.
Canada: Vancouver Pharmacy Receives MDMA Import License from Health Canada
On January 8, 2013, Health Canada issued the import license required to bring MDMA from Switzerland into Canada for our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD. The Canadian Institutional Review Board (IRB) approved the protocol on November 7, 2008, and Health Canada cleared the study on March 17, 2009. Since then, it has taken us almost four years to satisfy Health Canada’s pharmacy security requirements and obtain the import permit for nine grams of MDMA. We anticipate that obtaining the Swiss export permit will take a few weeks. Once the MDMA has arrived in Canada, we will submit a series of minor protocol revisions to Health Canada and to the Institutional Review Board. Once they are approved, which could take about a month, we will begin screening and treating subjects.
U.S. Veterans Study: Twelve of 24 Subjects Enrolled
On January 7, 2013, the 12th subject out of 24 was enrolled in our ongoing study of MDMA-assisted psychotherapy for U.S. veterans, firefighters, and police officers with chronic, treatment-resistant PTSD. This study began treating subjects on January 7, 2011, and is now halfway through enrollment. We began slowly but now have an inquiry list of over 369 people and plan to complete treating subjects by June 2014. Join researchers Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., at Psychedelic Science 2013 for a full-day workshop on the principles and practice of MDMA-assisted psychotherapy.
New Version of MDMA-Assisted Psychotherapy Treatment Manual Completed
New Version Released January 4, 2013: This manual provides researchers with a method of MDMA-assisted psychotherapy to be used as a model in conducting clinical trials to treat posttraumatic stress disorder (PTSD). The specific goals of this manual are to delineate the core elements of the MDMA-assisted psychotherapy method used in MAPS-sponsored PTSD treatment studies, and to educate therapists about the phases and steps involved in conducting MDMA-assisted psychotherapy for the treatment of PTSD. Download | Learn More
Switzerland: Results Published in Journal of Psychopharmacology
On January 1, 2013, the results from our now-completed Swiss pilot study of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD became published in the Journal of Psychopharmacology, a peer-reviewed scientific journal. The paper, co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies, the world’s largest organization for PTSD treatment providers and researchers, describes clinically (and almost statistically) significant decreases in PTSD symptoms following MDMA-assisted psychotherapy.
MAPS-Sponsored Clinical Trials: MDMA-Assisted Psychotherapy for PTSD
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 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.
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.
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.
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 is limited to up to 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), and is currently in progress.
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 will investigate 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.
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.
Andrew Feldmár was born in Budapest, Hungary in 1940, and arrived in Canada in 1957. He received is Honours B.A. In Mathematics, Physics, and Chemistry from the Universiy of Toronto in 1962, and his M.A. in Psychology from the University of Western Ontario in 1969. He has been in full-time private practice in psychotherapy since 1975, after a year's apprenticeship with R. D. Laing in London, England. He has been studying entheogens [psychedelics] since 1967. He supervises, teaches, lectures, and publishes both in North America and in Europe.
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.
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.
Mimi Peleg, Contract 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.
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) 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.
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.
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
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).
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.
MDMA-Assisted Therapy for the Treatment of Social Anxiety in Autistic Adults (Awaiting Approval)
Autism refers to a spectrum of congenital pervasive developmental disabilities. Comparative studies suggest that autistic adults are at greater risk for lifetime and current co-morbid mood and anxiety disorders, especially social anxiety. Autistic adults who are verbal and whose autism might not be immediately recognizable to others often initially present in a clinical setting with a co-morbid diagnosis of anxiety or depression. Social anxiety is characterized by fear of scrutiny and avoidance of social interactions and frequently compounds the considerable social challenges experienced by autistic adults.
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 proposing 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.
Charles Grob, M.D., and Alicia Danforth, Ph.D.(c), will be co-investigators for this study.
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 April 30, 2013: Protocol design approved by the U.S. Food and Drug Administration
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.
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.
MDMA Investigator's Brochure and FDA Annual Report
MDMA Investigator's Brochure
The 6th edition of MAPS’ 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.
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