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.

Research: Current Focus

Ongoing and Planned Trials

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.  EMA Phase 3 trials are anticipated to start in 2020, pending funding and regulatory approval by individual European countries. EMA agreed to accept for review the data that MAPS is gathering for FDA.

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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 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 initiated 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 2020.

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.


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