This randomised, double-blind, active placebo‑controlled Phase II pilot (n=10) compared low (25 mg) versus full (125 mg) MDMA‑assisted psychotherapy across two experimental sessions in people with chronic, treatment‑resistant PTSD.
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.
Open‑label full dose MDMA-assisted therapy lead‑in for first two participants.
Initial 125 mg with optional supplemental 62.5 mg 1.5–2.5 hours later; two experimental psychotherapy sessions (open‑label lead‑in).
Active placebo MDMA-assisted therapy (low dose) during two psychotherapy sessions.
Initial 25 mg with optional supplemental 12.5 mg 1.5–2.5 hours later; adjunct to psychotherapy.
Full dose MDMA-assisted therapy during two psychotherapy sessions.
Initial 125 mg with optional supplemental 62.5 mg 1.5–2.5 hours later; adjunct to psychotherapy.
This review (2019) details the potential superiority of MDMA-assisted psychotherapy as a treatment for PTSD compared to the conventional treatment options paroxetine and sertraline.