Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD
This multi-site, open-label, Phase II lead-in study (n=38) assesses safety and efficacy of three sessions of MDMA-assisted therapy (flexible MDMA dosing 80–120 mg with optional supplemental half-dose) in participants with at least severe PTSD.
Details
Multi-site, open-label, single-group Phase II study evaluating three preparatory psychotherapy sessions, three MDMA-assisted experimental sessions, and integrative psychotherapy following each MDMA session in adults with severe PTSD (n=38).
MDMA dosing per experimental session is flexible (initial 80–120 mg with a 40–60 mg supplemental dose 1.5–2 hours later; total per session 80–180 mg). Primary outcome is change in CAPS-5 from baseline to primary endpoint; safety assessed via AEs, vitals and laboratory measures.