A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least severe PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.

Timeline

Start

2018-11-21

Primary completion

2020-08-11

Completion

2020-08-21

Publications

• Results Mitchell JM, Bogenschutz M, Lilienstein A, Harrison C, Kleiman S, Parker-Guilbert K, Ot'alora G M, Garas W, Paleos C, Gorman I, Nicholas C, Mithoefer M, Carlin S, Poulter B, Mithoefer A, Quevedo S, Wells G, Klaire SS, van der Kolk B, Tzarfaty K, Amiaz R, Worthy R, Shannon S, Woolley JD, Marta C, Gelfand Y, Hapke E, Amar S, Wallach Y, Brown R, Hamilton S, Wang JB, Coker A, Matthews R, de Boer A, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021 Jun;27(6):1025-1033. doi: 10.1038/s41591-021-01336-3. Epub 2021 May 10.
• van der Kolk BA, Wang JB, Yehuda R, Bedrosian L, Coker AR, Harrison C, Mithoefer M, Yazar-Klosinki B, Emerson A, Doblin R. Effects of MDMA-assisted therapy for PTSD on self-experience. PLoS One. 2024 Jan 10;19(1):e0295926. doi: 10.1371/journal.pone.0295926. eCollection 2024.

Drugs

Indications