Randomized, double-blind, dose-comparison Phase II study (n=26) testing 30 mg, 75 mg, and 125 mg MDMA HCl plus psychotherapy in veterans with chronic PTSD.
Participants received preparatory non-drug therapy sessions then two blinded eight-hour MDMA-assisted therapy sessions (125 mg group received a third open-label session); supplemental half-dose given 1.5–2.5 hours after initial dose when agreed.
Outcomes include PTSD and depression symptoms, quality of life, posttraumatic growth, vital signs and adverse events assessed acutely and at follow-ups up to 12 months.
30 mg MDMA HCl with psychotherapy (two blinded sessions; possible open-label crossover).
Supplemental half-dose (15 mg) 1.5–2.5 h after initial; two blinded sessions; may enter open-label crossover with three sessions.
Non-directive psychotherapy with male and female co-therapist; preparatory and integration sessions
75 mg MDMA HCl with psychotherapy (two blinded sessions; possible open-label crossover).
Supplemental half-dose (37.5 mg) 1.5–2.5 h after initial; two blinded sessions; may enter open-label crossover.
Non-directive psychotherapy with male and female co-therapist; preparatory and integration sessions
125 mg MDMA HCl with psychotherapy (two blinded sessions plus a third open-label session).
Supplemental half-dose (62.5 mg) 1.5–2.5 h after initial; receives a third open-label experimental session.
Non-directive psychotherapy with male and female co-therapist; preparatory and integration sessions
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.