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

NCT04454684 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-10-31

No results posted yet for this study

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.

Conditions

  • Anorexia Nervosa Restricting Type
  • Binge-Eating Disorder

Interventions

DRUG

Midomafetamine

Initial dose of 80 or 120 mg midomafetamine HCl administered orally at the start of each of three psychotherapy sessions, followed by a supplemental half-dose of 40 to 60 mg midomafetamine HCl 1.5 to 2.5 hours later, unless contraindicated.

BEHAVIORAL

Non-directive therapy

Non-directive therapy will be conducted during Experimental Sessions.

BEHAVIORAL

Therapy

Therapy will be conducted during Preparatory Sessions and Integrative Sessions.

Sponsors & Collaborators

Principal Investigators

  • Adele Lafrance, PhD · Emotion Science

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-08-10
Completion
2028-08-10
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04454684 on ClinicalTrials.gov