Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD
Randomized, double-blind, active placebo‑controlled Phase II pilot (n=10) comparing low (25 mg) versus full (125 mg) MDMA‑assisted psychotherapy across two experimental sessions in people with chronic, treatment‑resistant PTSD.
Details
Participants received preparatory psychotherapy sessions, followed by two MDMA‑assisted psychotherapy sessions scheduled 3–5 weeks apart; each experimental session lasted approximately 6–8 hours and included psychotherapeutic support.
Stage 1 randomised participants received either an active placebo (25 mg, optional 12.5 mg supplemental) or full dose MDMA (125 mg, optional 62.5 mg supplemental); an open‑label lead‑in of full dose MDMA was conducted for the first two subjects, and participants who received active placebo could opt into an open‑label Stage 2 of full dose MDMA.
Outcomes included CAPS assessment at baseline and two months after the second session, safety measures, vital signs and measures of psychological distress during experimental sessions.