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MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study

Mitchell JM, Bogenschutz M, Lilienstein A, et al. · Nature Medicine, 2021

This phase 3 randomized, double-blind, placebo-controlled trial tested MDMA-assisted therapy for severe PTSD in 90 adults, including people with dissociation, depression, substance use histories and childhood trauma. Everyone received the same manualized therapy, with three preparation and nine integration sessions; the difference was whether the medicine sessions used MDMA or placebo. In this study, PTSD symptom scores fell more in the MDMA group than the placebo group two months after the last session, and functional impairment also improved more. The researchers did not observe signs of abuse potential, increased suicidality, or heart rhythm problems. A limitation is that the placebo group also improved considerably, and blinding is difficult with MDMA. MDMA remains a Schedule I substance and is not an approved treatment in the United States.

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Our summaries describe what each study found. They are not medical advice, and the practices at Halcyon are not a treatment for any condition.