drugset / Trial / NCT04454684

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

NCT04454684 ↗

Phase 2 Withdrawn Resilient Pharmaceuticals
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

Outcome

Outcome not reported

Stopped: “No site was initiated.”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Midomafetamine Unknown 80 mg Oral
Subject Midomafetamine Unknown 120 mg Oral