Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder
Randomised, triple-blind, placebo-controlled Phase II trial (n=14) of MDMA-assisted psychotherapy for PTSD comparing full dose (125 mg + optional 62.5 mg booster) versus low active placebo (25 mg + optional 12.5 mg booster) across three 8-hour therapy sessions.
Details
Randomised, triple-blind, parallel-group Phase II study in adults with PTSD resistant to at least one prior treatment, evaluating whether three 8-hour MDMA-assisted psychotherapy sessions reduce PTSD symptoms compared with a low (active placebo) MDMA dose.
Each experimental session includes administration of oral MDMA (125 mg or 25 mg) with an optional booster dose ~2.5 hours later, paired with non-directive psychotherapy by two co-therapists; assessments occur acutely and at 2, 6 and 12 months follow-up, with an open-label rollover offered to low-dose participants.
Safety monitoring included overnight observation after sessions, daily contact for one week post-session, and exclusion of participants with significant medical or psychiatric comorbidity.