A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders
Open-label Phase II multi-site study (n=18) assessing three sessions of MDMA-assisted psychotherapy (80–120 mg oral MDMA with supplemental half-doses) with preparatory and integrative therapy and caregiver involvement in female participants with AN‑R or BED.
Details
Open-label Phase II multi-site, non-randomised study enrolling 18 female participants (12 AN‑R, 6 BED) to evaluate safety and feasibility of MDMA-assisted psychotherapy with caregiver involvement.
Participants receive two preparatory sessions, three eight-hour MDMA-assisted therapy sessions (80–120 mg oral MDMA with supplemental half-doses 40–60 mg 1.5–2.5 h later), and multiple individual and dyadic integrative sessions; caregivers receive preparatory and integrative psychotherapy.
Primary outcome is change in Eating Disorder Examination (EDE) from baseline to study termination (Visit 16); safety and feasibility measures include adverse events, vitals and laboratory monitoring.