Changeflow GovPing Healthcare & Life Sciences Phase 1 MDMA Therapy for Bulimia Nervosa
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Phase 1 MDMA Therapy for Bulimia Nervosa

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Summary

The NIH ClinicalTrials.gov registry has registered a new Phase 1 clinical study (NCT07542145) evaluating MDMA Assisted Therapy (MDMA-AT) for Bulimia Nervosa. The 10-week trial will assign participants to MDMA-AT, MDMA-AT-BN, or Standard Treatment groups, with three experimental dosing sessions followed by integrative sessions, 12 psychotherapy sessions, and a 6-month follow-up.

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What changed

A new Phase 1 clinical trial registration for MDMA Assisted Therapy (MDMA-AT) has been posted to ClinicalTrials.gov under NIH. The study will examine MDMA-AT as a treatment for Bulimia Nervosa using a three-arm design comparing MDMA-AT, MDMA-AT-BN, and Standard Treatment.

Healthcare providers and clinical researchers treating or studying Bulimia Nervosa should be aware of this investigational study. Clinical trial registrations are informational records and do not create compliance obligations.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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MDMA Assisted Therapy for BN

Phase 1 NCT07542145 Kind: PHASE1 Apr 21, 2026

Abstract

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.

Conditions: Bulimia Nervosa

Interventions: MDMA-AT, MDMA-AT-BN, Standard Treatment (ST)

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Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Investigational drug study Psychotherapy research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Public Health

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