MDMA-Assisted Psychotherapy in Subjects with Posttraumatic Stress Disorder (Europe)​ (MP-18)

Written By Tiny Blue Dot Foundation

INSTITUTION: Multidisciplinary Association for Psychedelic Studies (MAPS)

PROJECT LEADERS: Rick Doblin, PhD; Amy Emerson; Eric Vermetten, MD; Sara Garcia Velazquez, MD

PROJECT DURATION: 2021 - 2024

LAB WEBSITE: MAPS Public Benefit

PTSD is a serious, debilitating disorder that negatively impacts the daily lives of hundreds of millions of people across the globe. PTSD can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, high-cost healthcare utilization, increased depression, and suicide. People who suffer from PTSD may relive the traumatic experience through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. Symptoms can be severe and long lasting. 

MDMA reduces fear of emotional injury, enables enhanced introspection and communication, and can increase empathy and compassion. These effects combine to allow individuals the emotional capability to face and address traumatic events which may have otherwise been too difficult to relive, or process, and do so with an increased capacity for self-compassion. The subjective effects of MDMA create a productive psychological state that enhances the therapeutic process.  

This project consists of two phases. The first phase is MP-18, an open-label, lead-in phase 2 study of safety and effectiveness of MDMA-assisted therapy as a treatment for people living with severe PTSD, primarily to train European therapists, followed by a Phase 3 study. MP-18 is the first multi-site study of MDMA-assisted therapy in Europe with study sites in the United Kingdom, Portugal, Norway, the Netherlands, Germany, the Czech Republic, and Spain. Forty study participants will receive two sessions of MDMA-assisted therapy with effectiveness evaluated by pre- and post-trial measures.

Broader Impact:

MP-18 coincides with similarly designed Phase 3 trials conducted by MAPS in the United States, Israel, and Canada. MAPS has already completed an initial Phase 3 trial and published the results in 2021. The results showed that 67% of study participants who received MDMA-assisted therapy no longer met the diagnostic criteria for PTSD, while another 21% saw a clinically significant decrease in symptoms. 

If results are replicated in a second confirmatory Phase 3 trial in the United States, Israel, and Canada, regulatory approval will follow. A European Phase 3 study in 70 subjects is needed for European approval. Then, hundreds of millions of people around the world will gain access to this promising treatment and, over time, be relieved of the suffering and devastating effects of PTSD.

Publications:

  • J.M. Mitchell, et al., MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 27, 1025–1033 (2021). 

  • M.C. Mithoefer, et al., Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: A prospective long-term follow-up study. Journal of Psychopharmacology 27, 28-39 (2013).

  • P. Oehen, R. Traber, V. Widmer and U. Schnyder, A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine) assisted psychotherapy for treatment of resistant, chronic post-traumatic stress disorder (PTSD). Journal of Psychopharmacology 27, 40–52 (2013).

  • M.C. Mithoefer, et al., 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: A randomised, double-blind, dose-response, phase 2 clinical trial. The Lancet Psychiatry 7, 486-497 (2018). 

  • G.M. Ot’alora, et al.,  3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial. Journal of Psychopharmacology 32, 1295-1307 (2018).

  • MP-18 (Active European Phase 2 Study Protocol) - https://files2.mapseurope.eu/wp-content/uploads/2021/01/08213631/MP18-Protocol-V5.3-Redacted-15OCT2020.pdf

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