Posttraumatic stress disorder (PTSD) is a prevalent mental health condition that affects the lives of millions of people each year. Here we report the findings of the first randomized, double-blind, placebo-controlled, Phase 3 trial assessing the efficacy and safety of MDMA-assisted psychotherapy for the treatment of severe PTSD. A flexible dose of MDMA or placebo was administered to participants (n = 100) under direct observation and over 3 treatment sessions in conjunction with manualized psychotherapy. The treatment population included those with common comorbidities such as dissociation, depression, history of alcohol and substance use disorders (ASUDs), and childhood trauma. Change in PTSD symptoms (CAPS-5) and functional impairment (SDS) were assessed by a central, blinded Independent Rater Pool at baseline and following each treatment session. Adverse events (AEs), concomitant medications, suicidal ideation and behavior were tracked throughout the study and vital signs were measured during experimental sessions. MDMA plus therapy significantly attenuated CAPS-5 Total Severity Score compared to placebo plus therapy (n = 89, p &lt; .0001; d = 0.91, 95% CI = (0.44, 1.37)) and significantly decreased the SDS total score (n = 89, p = .0116; d = 0.43, 95% CI = (-0.01, 0.88)). The mean change in CAPS-5 scores was -24.4 (11.6), n = 42 in the MDMA plus therapy group and -13.9 (11.5), n = 37 in the Placebo plus therapy group. Compared to placebo plus therapy, not only was MDMA-assisted therapy highly efficacious in those suffering from severe PTSD but it was safe and well-tolerated, even in those with comorbidities. The results presented here will form the basis for marketing authorization applications worldwide and suggest that MDMA merits rapid clinical development for treatment of PTSD.

Durable improvements in PTSD following MDMA-assisted therapy

ACS Spring 2022

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