drugset / Trial / NCT04454684
A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy and caregiver involvement are safe and effective in treating female participants with eating disorders. The main question it aims to answer is: Does MDMA-assisted therapy reduce eating disorder symptoms? Participants will undergo two non-drug preparatory therapy sessions and their caregiver will undergo one non-drug preparatory therapy session. Participants will undergo three sessions of MDMA-assisted therapy followed by non-drug integrative therapy sessions alone as well as together with their caregiver.
Timeline
- Start
- 2026-02
- Primary completion
- 2028-08-10
- Completion
- 2028-08-10
Publications
- Background Cooper, Z. and C. Fairburn, The eating disorder examination: A semi-structured interview for the assessment of the specific psychopathology of eating disorders. International journal of eating disorders, 1987. 6(1): p. 1-8.
- Background Fairburn, C., Z. Cooper, and M. O'Connor, Eating Disorder Examination (Edition 17.0D; April, 2014). 2014: https://www.corc.uk.net/media/1951/ede_170d.pdf.
- Background Keel PK, Brown TA. Update on course and outcome in eating disorders. Int J Eat Disord. 2010 Apr;43(3):195-204. doi: 10.1002/eat.20810.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midomafetamine | Unknown | 80 mg | Oral |
| Subject | Midomafetamine | Unknown | 120 mg | Oral |