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.
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.
Three 8-hour MDMA-assisted psychotherapy sessions (125 mg + optional 62.5 mg booster) with non-directive therapy by two co-therapists.
125 mg initial dose each session; optional 62.5 mg booster ~2.5 h after initial dose if agreed.
Non-directive therapy performed by two co-therapists during each dosing session and in integration/follow-up.
Three 8-hour MDMA-assisted psychotherapy sessions (25 mg + optional 12.5 mg booster) with same therapy.
25 mg initial dose each session; optional 12.5 mg booster ~2.5 h after initial dose if agreed.
Non-directive therapy performed by two co-therapists during each dosing session and in integration/follow-up.
A pooled analysis of six randomised, double‑blind phase 2 trials found MDMA‑assisted psychotherapy produced large, clinically meaningful reductions in PTSD symptoms versus control (MMRM mean difference −22.0; Cohen’s d = 0.8) with higher remission rates (54.2% vs 22.6%) and acceptable tolerability, providing the rationale and design basis for phase 3 trials and FDA Breakthrough Therapy designation.