Randomized Placebo-controlled Study of MDMA-assisted Psychotherapy in People With PTSD – Israel
Randomised, triple-blind Phase II trial (n=12) comparing two sessions of full-dose MDMA-assisted psychotherapy (125 mg + 62.5 mg supplemental) versus low-dose active placebo MDMA (25 mg + 12.5 mg) for chronic PTSD.
Details
Participants are randomised to receive two day-long MDMA-assisted psychotherapy sessions given two to four weeks apart, either full therapeutic dose or low active placebo dose, with preparatory and integration therapy sessions.
The full dose regimen is 125 mg orally with a supplemental 62.5 mg 2–2.5 hours later; the low dose regimen is 25 mg with a 12.5 mg supplement. PTSD symptoms are measured at baseline and at 2, 6 and 12 months after the second experimental session.
Participants who received low dose may enter an open-label continuation receiving two additional full-dose sessions with follow-up assessments at 6 and 12 months.