A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders

This Phase 2, open-label, multi-site study will explore the safety and feasibility of MDMA-assisted psychotherapy and adjunctive caregiver involvement in the treatment of 18 participants with eating disorders.

The study will enroll 12 participants with anorexia nervosa restricting-type (AN-R) and six participants with binge eating disorder (BED). A supportive caregiver, such as a parent or partner, for each participant will also be recruited to participate in the study and receive non-drug psychotherapy support. The study will consist of Preparatory Sessions, Experimental Sessions of MDMA-assisted psychotherapy, as well as Individual and Dyadic Integrative Sessions.

A flexible dose of MDMA will be given during Experimental Sessions, ranging from 80 to 120 mg with a supplemental half-dose of 40 or 60 mg 1.5 to 2 hours later, respectively, unless contraindicated. The primary outcome measure is the change in Eating Disorder Examination (EDE) results from Baseline to Visit 16 (Study Termination).

Topic Eating Disorders
Compound MDMA
Country United States of America
Visit trial

Trial Details



Trial Number

Sponsors & Collaborators

MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

Measures Used

Eating Disorder Examination Interview
The Eating Disorder Examination Interview (EDE) is a semi-structured interview conducted by a clinician that has been modified to reflect the current DSM-5 diagnosis. The EDE is rated using four subscales; restraint, eating concern, shape concern and weight concern.

Data attribution

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