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

Medicine and Health

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

J. M. Mitchell, M. Bogenschutz, et al.

Discover groundbreaking insights from a phase 3 clinical trial investigating MDMA-assisted therapy for severe PTSD, revealing significant reductions in symptoms and functional impairment. Conducted by a team of leading experts, this research highlights the potential for high efficacy and safety in treating PTSD, even alongside comorbidities.

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Playback language: English
Abstract
This randomized, double-blind, placebo-controlled phase 3 clinical trial (NCT03537014) tested the efficacy and safety of MDMA-assisted therapy for severe PTSD. 90 participants received manualized therapy with MDMA or placebo. MDMA significantly reduced PTSD symptoms (CAPS-5) and functional impairment (SDS) compared to placebo. No significant adverse events related to abuse potential, suicidality, or QT prolongation were observed. MDMA-assisted therapy shows high efficacy and safety for severe PTSD, even with comorbidities, meriting expedited clinical evaluation.
Publisher
Nature Medicine
Published On
May 10, 2021
Authors
Jennifer M. Mitchell, Michael Bogenschutz, Alia Lilienstein, Charlotte Harrison, Sarah Kleiman, Kelly Parker-Guilbert, Marcela Ot'alora G., Wael Garas, Casey Paleos, Ingmar Gorman, Christopher Nicholas, Michael Mithoefer, Shannon Carlin, Bruce Poulter, Ann Mithoefer, Sylvestre Quevedo, Gregory Wells, Sukhpreet S. Klaire, Bessel van der Kolk, Keren Tzarfaty, Revital Amiaz, Ray Worthy, Scott Shannon, Joshua D. Woolley, Cole Marta, Yevgeniy Gelfand, Emma Hapke, Simon Amar, Yair Wallach, Randall Brown, Scott Hamilton, Julie B. Wang, Allison Coker, Rebecca Matthews, Alberdina de Boer, Berra Yazar-Klosinski, Amy Emerson, Rick Doblin
Tags
MDMA
PTSD
therapy
clinical trial
safety
efficacy
comorbidities

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