Research: Current Focus
Ongoing and Planned Trials
Since 2018, MAPS Europe has focused on training study therapists in preparation for the planned European Phase 3 trial, MAPP–3. The MDMA Therapy Training Program includes an online course, an experiential component, role play, and supervision of the trainee’s first MDMA-assisted therapy participant. With European therapist training complete, the focus is now on completing the Phase 2 open-label, lead-in, Phase 2 study, MP-18.
European sites and investigators have been identified and MAPS Europe has begun recruiting participants for MP-18. The study is planned at nine clinical research sites , across six countries, including the United Kingdom, The Netherlands, Czech Republic, Germany, Norway, and Portugal. The purpose of MP-18 is to gather European Phase 2 data and finalize the training of investigators. After the completion of MP-18, MAPS Europe plans to conduct a much larger Phase 3 clinical trial, called MAPP–3, which will be conducted at the same research sites as MP–18.
Study Design and European Medicines Agency (EMA) Guidance
MAPS’ proposed sample size for the European pPhase 3 trial MAPP3 is 70 PTSD participants 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 the 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 for the European Phase 3 trial, which is currently expected to start in 2022.
Recent Results of MDMA-Assisted Therapy Trials
The first Phase 3 trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD), which took place in the United States, Canada and Israel, replicated and expanded on Phase 2 results and suggested that MDMA-assisted therapy will be an effective and cost-saving treatment for PTSD resulting from any cause. Nature Medicine, one of the most impactful medical journals, has published a peer-reviewed paper detailing the results of the study. In this first Phase 3 trial of any psychedelic-assisted therapy, 67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis and 88% experienced a clinically meaningful reduction in symptoms.
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.
MAPS is currently seeking $30 million for EMA trials, with $900,000 already raised. MAPS will continue to raise funds from donations while serving as parent organization and sole shareholder of MAPS PBC and MAPS Europe. Both MAPS PBC and MAPS Europe are key parts of MAPS’ strategy to become a sustainable non-profit organization through reasonable income from sales of MDMA by prescription.
Please be advised that the MAPS Europe Board of Directors has established a published policy of limiting indirect overhead expenses to 10% of direct costs.
Since our founding in 1986, MAPS has disbursed over $100 million to developing psychedelics and marijuana into prescription medicines and to educating the public honestly about the risks and benefits of these substances. All of MAPS’ funding has come from visionary donors committed to our mission. To make a donation, you can donate online or email email@example.com. If you are from outside the U.S. and would like a tax –deduction in your country, please contact MAPS. We have collaborative agreements with other similar non-profits in several European countries.