WithdrawnPhase 2

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

Stopped: No site was initiated.

0Started 2026-02

Plain-language 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.

Who can participate

Age range

21 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Eating Disorder (ED) Participants: * Are 21 to 65 years old. * Are assigned female at birth. * Are fluent in speaking and reading the English language and can provide written informed consent. * Are able to swallow pills. * Agree to have study visits recorded to audio and video. * Are willing to include a consenting caregiver as a co-participant in elements of the study with whom the study team will have regular contact. This person must be willing and able to be reached by the investigators in case of emergency. * If connected to a psychotherapist at the time of recruitment into the study, participants may not change therapists, change the frequency of therapy, or commence any new type of therapy until after the Study Termination Visit, 1 month after the final Experimental Session. * Have an identified Primary Care Physician (PCP) and provide consent for the investigator to communicate with PCP, as needed. * If AN-R diagnosis, are currently participating in a recognized ED treatment program. * Are willing to sign a release for the investigators to communicate directly with their therapist, physician if relevant, as well treatment providers where they were currently or previously engaged an ED-specific episode of treatment. * Live within reasonable driving distance of the study site (equal to or less than an estimated 2-hour drive from the study site). * If of childbearing potential, must have a negative pregnancy test at study entry and prior to each …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Eating Disorder Examination Interview (EDE) Global Score from Baseline to Visit 16 (Study Termination)

Timeframe: Baseline to 17 weeks post-enrollment

Trial details

NCT IDNCT04454684

SponsorResilient Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-08-10

View on ClinicalTrials.gov More Anorexia Nervosa Restricting Type trials