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NCT07542145 · ClinicalTrials.gov registry record · Phase 1
MDMA Assisted Therapy for BN
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT07542145: Recruiting Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT07542145 is a Phase 1 study that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07542145, a Phase 1 study, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Eating Disorder Examination Questionnaire (EDEQ) is administered to assess psychopathology of eating disorders using 28 items. Binge eating frequency (count of binge eating episodes) is a question measured in this assessment. Higher frequency indicates higher severity.
Interventions
- DRUG MDMA-AT
- DRUG MDMA-AT-BN
- BEHAVIORAL Standard Treatment (ST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-05-22 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 1 |
What NCT07542145 shows while recruiting
NCT07542145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which MDMA-AT is the first listed.
NCT07542145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07542145 about?
NCT07542145 is a clinical study titled "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 se...
What is the current status of trial NCT07542145?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-05-22. Estimated completion is 2028-04-30.
What interventions are being tested in trial NCT07542145?
The interventions under investigation include: MDMA-AT (DRUG), MDMA-AT-BN (DRUG), Standard Treatment (ST) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07542145?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07542145's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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