A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD
This randomised, double-blind, placebo-controlled Phase 3 study (n=121) compares three sessions of MDMA-assisted psychotherapy (initial 80–120 mg with supplemental half-dose 40–60 mg) versus placebo with identical therapy in adults with moderate PTSD.
Details
This multi-site, randomized, triple-masked Phase 3 trial evaluates whether three sessions of MDMA-assisted psychotherapy reduce PTSD symptoms compared with identical psychotherapy plus inactive placebo.
Each participant receives three preparatory non-drug therapy sessions, three experimental medication-assisted therapy sessions (initial 80 or 120 mg midomafetamine HCl followed 1.5–2 hours later by a supplemental half-dose of 40 or 60 mg unless contraindicated), and three integrative non-drug therapy sessions after each experimental session.
Primary outcome is change in CAPS-5 total severity from baseline to 18 weeks; key secondary outcomes include clinician-rated functional impairment (Sheehan Disability Scale items).