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

This is an open-label, expanded access protocol for eligible patients with treatment-resistant PTSD. This protocol is designed to provide access to MDMA-assisted therapy for patients who are not eligible for participation in another ongoing MDMA-assisted therapy clinical trial. In addition, this program will provide supportive data on safety and tolerability of MDMA-assisted therapy in treatment-resistant patients with PTSD. The study will treat up to 50 patients. A flexible dose of MDMA (80 to 120 mg midomafetamine HCl), followed by a supplemental dose unless contraindicated, is administered during the Treatment Period with manualized therapy in up to three open-label Experimental Sessions. During the Treatment Period, each Experimental Session is preceded by three 90-minute Preparatory Sessions and followed by three 90-minute Integrative Sessions of non-drug therapy. Experimental Sessions will be followed by an overnight stay.