This Phase II, triple-blind, randomised, placebo-controlled study (n=23) evaluates MDMA-assisted therapy (125 mg + 62.5 mg) across two 8-hour sessions for chronic, treatment-resistant PTSD.
Randomised, triple-blind, placebo-controlled trial comparing MDMA-assisted psychotherapy with psychotherapy plus inactive placebo in adults with chronic, treatment-resistant PTSD, including veterans.
Participants received two blinded 8-hour sessions (125 mg oral MDMA with a 62.5 mg supplemental dose, or matched placebo), with preparatory and integration therapy. Primary outcome: change in CAPS-IV two months post-treatment.
Two 8-hour MDMA-assisted psychotherapy sessions with a divided dose (125 mg + 62.5 mg).
Supplemental 62.5 mg 2–2.5 h after initial dose.
Two 8-hour psychotherapy sessions with inactive placebo.
In a prospective long-term follow‑up (mean 45.4 months) of the first MDMA‑assisted psychotherapy trial for chronic, treatment‑resistant PTSD (n=19; 16 CAPS completers), symptom reductions observed at study exit were largely maintained (mean CAPS 24.6 vs 23.7; p=0.91) though two participants relapsed. No participants reported harm or evidence of drug dependency, suggesting durable clinical benefit and a favourable safety profile.