drugset / Trial / NCT07542145

MDMA Assisted Therapy for BN

NCT07542145 ↗

Phase 1 Recruiting 40 enrolled Icahn School of Medicine at Mount Sinai
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-05-22
Primary completion
2028-04-30
Completion
2028-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MDMA Unknown — —

Indications