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Phase 3 trial suggests benefit of MDMA‐assisted therapy for PTSD

The Brown University Psychopharmacology Update August 1, 2021 DOI: 10.1002/pu.30752 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Peer reviewed
Intervention MDMA
Topics MDMA PTSD
Key findings Adding MDMA to manualized therapy for PTSD resulted in significant symptom improvement and reduced functional impairment relative to placebo, with no increase in adverse events.

Abstract

Adding 3,4‐methylenedioxymethamphetamine (MDMA) to manualized therapy for post‐traumatic stress disorder (PTSD) resulted in significant symptom improvement and reduced functional impairment relative to placebo in a Phase 3 trial. The researchers observed no increase in adverse events from use of MDMA, including no increase in suicidality. Study results were published online May 10 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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