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NOT YET RECRUITING
NCT07542145
PHASE1

MDMA Assisted Therapy for BN

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

Official title: MDMA Assisted Therapy for Bulimia Nervosa: A Treatment Development Protocol

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-05

Completion Date

2028-04-30

Last Updated

2026-04-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

MDMA-AT

MDMA-AT assisted psychotherapy (MDMA-AT) assignment includes 3 experimental (medicine) sessions, occurring 3 weeks apart and 9 integrative sessions over the course of 10 weeks. These are followed by 12 sessions of non-specific eating disorder psychotherapy.

DRUG

MDMA-AT-BN

MDMA-AT assisted psychotherapy specific to BN (MDMA-AT-BN) assignment includes 3 experimental (medicine) sessions, occurring 3 weeks apart and 9 integrative sessions over the course of 10 weeks. These are followed by 12 sessions of BN-specific eating disorder psychotherapy.

BEHAVIORAL

Standard Treatment (ST)

Standard Treatment (ST) for BN assignment includes weekly therapy sessions for 22 weeks.

Locations (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, United States