logo
ResearchBunny Logo
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.

00:00
00:00
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

Related Publications

Explore these studies to deepen your understanding of the subject.

Efficacy of green jackfruit flour as a medical nutrition therapy replacing rice or wheat in patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study
Medicine and Health

Efficacy of green jackfruit flour as a medical nutrition therapy replacing rice or wheat in patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study

A. G. Rao, K. S. Naik, et al.

A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression
Medicine and Health

A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression

P. R. Shiroma, P. Thuras, et al.

Comparative acute effects of mescaline, lysergic acid diethylamide, and psilocybin in a randomized, double-blind, placebo-controlled cross-over study in healthy participants
Medicine and Health

Comparative acute effects of mescaline, lysergic acid diethylamide, and psilocybin in a randomized, double-blind, placebo-controlled cross-over study in healthy participants

L. Leyl, F. Holze, et al.

Acute effects of MDMA and LSD co-administration in a double-blind placebo-controlled study in healthy participants
Medicine and Health

Acute effects of MDMA and LSD co-administration in a double-blind placebo-controlled study in healthy participants

I. Straumann, L. Ley, et al.

Listen, Learn & Level Up
Over 10,000 hours of research content in 25+ fields, available in 12+ languages.
No more digging through PDFs, just hit play and absorb the world's latest research in your language, on your time.
listen to research audio papers with researchbunny