MDMA Assisted Therapy for BN

This project will evaluate MDMA Assisted Therapy (MDMA-AT) assisted psychotherapy for the treatment of Bulimia Nervosa (BN) over a 10-week period. Preliminary data suggests that MDMA can facilitate heightened openness and reduce anxiety. This study will determine whether MDMA-assisted therapy can serve as a new treatment for BN. Participants are assigned to one of three groups: MDMA-AT, MDMA-AT-BN, and Standard Treatment (ST). MDMA groups include three experimental session that include dosing, which are each followed by three integrative sessions and also include 12 psychotherapy sessions. A follow-up will take place at 6-months post baseline.

NCT Number	NCT07542145
Lead Sponsor	Icahn School of Medicine at Mount Sinai
Conditions	Bulimia Nervosa
Enrollment	40 participants
Start Date	2026-05-22
Primary Completion	2028-04-30 (estimated)
Study Completion	2028-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-22