MAPS Europe and MAPS Public Benefit Corporation (MAPS PBC) are wholly-owned subsidiaries of the Multidisciplinary Association for Psychedelic Studies (MAPS). Their primary work is completing Phase 3 clinical trials required to develop MDMA-assisted psychotherapy into an approved treatment for PTSD.

What is MDMA-Assisted Psychotherapy?

Therapy in conjunction with 3,4-methylenedioxymethamphetamine (MDMA).  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.

We are studying whether MDMA-assisted psychotherapy can help heal the psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas. We are also studying MDMA-assisted therapy for autistic adults with social anxiety, and MDMA-assisted psychotherapy for anxiety related to life-threatening illnesses.

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.

Research: Current Focus

Phase 3 Trials Regulated by European Medicines Agency (EMA)

On June 12, 2018, MAPS met in London with the Scientific Advice Working Party of the European Medicines Agency (EMA). On June 28, MAPS received written scientific advice about its Phase 3 protocol and overall drug development plans, with approval to proceed to a Phase 3 trial in Europe. MAPS has also applied for the EMA equivalent of Breakthrough Therapy, known as PRIME. EMA Phase 3 trials are anticipated to start in the summer of 2019, pending funding and regulatory approval by individual European countries. MAPS has raised $27 million in donations for Phase 3 trials for FDA. Since EMA agreed to accept for review the data that MAPS is gathering for FDA, estimated costs for Phase 3 for Europe are only $9 million, of which MAPS has already raised $900,000.

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European Medicines Agency Study Design

MAPS’ proposed sample size for the European Phase 3 trial is 70 PTSD patients across nine study sites, with half of participants receiving manualized therapy with inactive placebo and half receiving manualized therapy with MDMA.

Based on scientific advice from EMA, MAPS aims to ensure cross-cultural validity of the research by including geographically diverse sites. In addition, EMA requested the inclusion of migrants and refugees with PTSD.

FDA Drug Development Progress

In 2016, 30 years after after its founding, MAPS completed an international series of six Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD. In these studies, preliminary evidence in over 100 subjects with chronic, treatment-resistant PTSD suggested the treatment was effective and well tolerated. These studies supported FDA and EMA expansion into Phase 3 trials and led to the FDA granting Breakthrough Therapy designation for MDMA-assisted psychotherapy for PTSD. In November 2018, MAPS will initiate a large-scale, multi-site Phase 3 trial for MDMA-assisted psychotherapy for PTSD at up to 16 sites to enroll 200-300 participants across the U.S., Canada, and Israel. The data will support a New Drug Application (NDA) to FDA, and will also support the Marketing Authorization Application (MAA) for EMA.

Phase 2 MDMA-Assisted Psychotherapy for PTSD Results

In the pooled data from the six Phase 3 trials, significant symptom reductions were seen in a large sample of participants with chronic, treatment resistant PTSD following MDMA-assisted psychotherapy. Over 2/3 of the subjects no longer qualified for a diagnosis of PTSD at the 12-month follow-up after the last MDMA-assisted psychotherapy session. The effectiveness of the treatment was not dependent on the cause of PTSD, demonstrating the generalizability of this treatment approach.

 

EMA Phase 3 trials are scheduled to start late in the summer of 2019.

Participate

MDMA Therapy Training Program in Europe

The MDMA Therapy Training Program is a five-part program designed to prepare researchers to work on Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. From September 27 – October 3, 2018, in Landgraaf, The Netherlands, MAPS PBC staff and researchers led the week-long training for 60 therapists planning to participate in Phase 3 MDMA-assisted psychotherapy for PTSD trials or related research in Europe and elsewhere. Participants came from many countries, including Australia, Afghanistan, China, Czech Republic, Denmark, England, Finland, Germany, Israel, Netherlands, Norway, Portugal, Spain, and Slovakia.

The Training Includes:

  • Part A: a 14-hour online course
  • Part B: a week-long residential training with review of actual videos of therapeutic sessions and instruction on MAPS’ therapeutic method about how to conduct sessions
  • Part C: an experiential elective in which trainees have the opportunity to volunteer for a clinical trial as a subject in which they will receive MDMA-assisted psychotherapy
  • Part D: a day-long role play
  • Part E: a supervision and evaluation study where the trainees provide MDMA-assisted psychotherapy to one PTSD patient and receive feedback from a supervising senior researcher.

Recent Training: The Netherlands

Above: A session from our recent MDMA Therapy Training in Landgraaf, The Netherlands.

Below: The MDMA Therapy Training Program hosts the first training in Europe.  Seen here is a group photo of the participants.

MP18 Study Protocol [PDF]

Participate in Research

MAPS Europe B.V. sponsors clinical trials in Europe that offer volunteers the opportunity to participate in our research studies. Our studies have strict enrollment criteria based on the goal of the study and the condition the study is investigating.

More information about MAPS-sponsored clinical trials, as well as other ongoing clinical trials in the U.S. and around the world, can be found at ClinicalTrials.gov. MDMA study sponsored by MAPS Europe B.V.

Europe: A multi-Site Phase 2 Study of MDMA-Assisted Psychotherapy

Note: this study is not enrolling participants yet. As soon as study is active ClinicalTrials.gov website will be updated with the study information including study location’s details.

Connect

For more information, please contact us at askmapseu@mapseurope.eu.