A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD

Open-label expanded access programme providing MDMA-assisted psychotherapy to treatment-resistant PTSD patients who cannot join other MDMA trials; intended to provide safety and tolerability data and treat up to 50 patients.

Participants receive 3 preparatory non-drug therapy sessions, up to 3 open-label MDMA-assisted therapy sessions (initial 80–120 mg with supplemental 40 or 60 mg 1.5–2 hours later as indicated) each followed by overnight stay and 3 integrative 90-minute sessions.