MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study
Summary & key facts
This randomized, double-blind phase 3 trial tested MDMA-assisted therapy versus placebo with the same therapy in 90 adults with severe PTSD. Participants had three drug sessions plus preparatory and integration therapy, and were assessed 18 weeks after starting. The MDMA group had larger drops in PTSD symptoms and in functional impairment than the placebo group. Side effects were usually mild or moderate and temporary, and the authors reported no signs of drug abuse, increased suicidality, or heart QT prolongation in the study period.
- 90 participants were randomized 1:1 (46 to MDMA-assisted therapy, 44 to placebo with therapy).
- Primary outcome (CAPS-5 PTSD severity) fell by a mean of −24.4 (s.d. 11.6) in the MDMA group and −13.9 (s.d. 11.5) in the placebo group among treatment completers.
- The between-group difference on CAPS-5 was statistically significant (P < 0.0001) with an effect size d = 0.91 (95% CI = 0.44–1.37).
- Functional impairment (Sheehan Disability Scale) decreased more with MDMA: mean change −3.1 (s.d. 2.6) versus −2.0 (s.d. 2.4); this difference was significant (P = 0.0116) with effect size d = 0.43.
- At the primary endpoint (18 weeks), 28 of 42 (67%) participants in the MDMA group no longer met diagnostic criteria for PTSD, compared with 12 of 37 (32%) in the placebo group. Remission (CAPS-5 ≤11 and loss of diagnosis) occurred in 14 of
- The trial included people with common comorbidities linked to treatment resistance (for example, dissociation, depression, prior substance or alcohol use disorder). MDMA showed similar benefit in participants with and without the dissociati
- Treatment-emergent adverse events more common with MDMA were generally transient and mild-to-moderate. Examples included muscle tightness, decreased appetite, nausea, excessive sweating, and feeling cold.
- The authors report that MDMA did not produce adverse events of abuse potential, increased suicidality, or QT interval prolongation during the study. The paper describes these results as supporting MDMA-assisted therapy as a potential breakt
Topics
Cannabis and Cannabinoid Research Psychedelics and Drug Studies Sleep and Wakefulness ResearchCategories
Clinical Psychology Psychology Social SciencesTags
Adverse effect Alternative medicine Clinical endpoint Internal medicine MDMA Medicine Pathology Placebo Psychiatry Psychology Randomized controlled trialReferencing articles
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