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Characteristics
Randomized controlled trial
Peer reviewed
Population
People with post-traumatic stress disorder
Duration
3 months
Topics
MDMA
PTSD
Key findings
MDMA-assisted therapy significantly improved PTSD symptoms and functional impairment compared with placebo plus therapy.
Abstract
Three sessions of 3,4‐methylenedioxymethamphetamine (MDMA)‐assisted therapy over 3 months significantly improved symptoms of post‐traumatic stress disorder (PTSD) compared with placebo plus therapy in a Phase 3 trial. MDMA‐assisted therapy also resulted in improvement in a measure of functional impairment. Study results were published online Sept. 14, 2023, in Nature Medicine.
Comparable studies
Other randomized controlled trials on
MDMA for PTSD , most cited first.
Study
Year
Design
Participants
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
Patients with severe PTSD, including those with comorbidities such as dissociation,...
2021
Randomized controlled trial
n = 90
The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.
Patients with chronic post-traumatic stress disorder refractory to both psychotherapy...
2010
Randomized controlled trial
n = 20
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial.
Military veterans and first responders aged 18 or older with chronic PTSD lasting 6...
2018
Randomized, double-blind, dose-response, phase 2 clinical trial
n = 26
A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD)
Patients with treatment-resistant PTSD
2012
Randomized controlled trial
n = 12
MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial.
Adults with moderate to severe post-traumatic stress disorder
2023
Randomized controlled trial
n = 104
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Related reading
Phase 3 trial suggests benefit of MDMA‐assisted therapy for PTSD
The Brown University Psychopharmacology Update
August 1, 2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
Nature Medicine
June 1, 2021
965 citations
MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.
Focus (American Psychiatric Publishing)
July 1, 2023
97 citations
MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial.
Nature Medicine
October 1, 2023
400 citations
MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials.
Psychopharmacology
September 1, 2019
364 citations
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