A study into the safety and effects of psychotherapy in combination with MDMA as a treatment for severe post-traumatic stress disorder
Open-label Phase II single-arm study (n=0 anticipated) of manualized MDMA-assisted psychotherapy for severe PTSD; three monthly MDMA sessions (80–180 mg per session, oral, with supplemental half-dose) plus preparatory and integrative non-drug psychotherapy.
Details
Open-label lead-in Phase 2 study evaluating safety and effect of manualized MDMA-assisted psychotherapy for severe PTSD at sites planned for Phase 3; participants receive non-drug preparatory and integrative psychotherapy plus three experimental MDMA-assisted sessions.
Each Experimental Session uses a flexible oral MDMA regimen (initial 80 or 120 mg with a supplemental half-dose of 40 or 60 mg 1.5–2 hours later; total per session 80–180 mg) and outcomes include change in CAPS-5 from baseline to 18 weeks, safety assessments (AEs, SAEs, vitals) and central independent rater evaluation.
The study aims to gather supportive safety/effect data and provide clinical supervision to therapy teams ahead of planned Phase 3 trials.