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MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.
Focus (Am Psychiatr Publ)
July 2023
Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA. e-mail:
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants ( = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions.
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