MDMA Assisted Therapy for BN

NCT07542145 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-23-00894
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate MDMA Assisted Therapy (MDMA-AT) assisted psychotherapy for the treatment of Bulimia Nervosa (BN) over a 10-week period. Preliminary data suggests that MDMA can facilitate heightened openness and reduce anxiety. This study will determine whether MDMA-assisted therapy can serve as a new treatment for BN. Participants are assigned to one of three groups: MDMA-AT, MDMA-AT-BN, and Standard Treatment (ST). MDMA groups include three experimental session that include dosing, which are each followed by three integrative sessions and also include 12 psychotherapy sessions. A follow-up will take place at 6-months post baseline.

Conditions

Bulimia Nervosa

Keywords

Bulimia Nervosa; MDMA-assisted therapy; Eating Disorders; Binge Eating; BN

Outcome Measures

Primary Outcomes (1)

• Binge Eating Episode Frequency

  Eating Disorder Examination Questionnaire (EDEQ) is administered to assess psychopathology of eating disorders using 28 items. Binge eating frequency (count of binge eating episodes) is a question measured in this assessment. Higher frequency indicates higher severity.

  Up to 6 months

Secondary Outcomes (1)

• Binge Eating Severity

  Up to 6 months

Study Arms (3)

MDMA-AT

EXPERIMENTAL

This assignment includes 3 experimental (medicine) sessions, occurring 3 weeks apart and 9 integrative sessions over the course of 10 weeks. These are followed by 12 sessions of non-specific eating disorder psychotherapy.

Drug: MDMA-AT

MDMA-AT-BN

EXPERIMENTAL

This assignment includes 3 experimental (medicine) sessions, occurring 3 weeks apart and 9 integrative sessions over the course of 10 weeks. These are followed by 12 sessions of BN-specific eating disorder psychotherapy.

Drug: MDMA-AT-BN

Standard Treatment (ST)

ACTIVE COMPARATOR

This assignment includes weekly therapy sessions for 22 weeks.

Behavioral: Standard Treatment (ST)

Interventions

MDMA-AT DRUG

MDMA-AT assisted psychotherapy (MDMA-AT) assignment includes 3 experimental (medicine) sessions, occurring 3 weeks apart and 9 integrative sessions over the course of 10 weeks. These are followed by 12 sessions of non-specific eating disorder psychotherapy.

MDMA-AT

MDMA-AT-BN DRUG

MDMA-AT assisted psychotherapy specific to BN (MDMA-AT-BN) assignment includes 3 experimental (medicine) sessions, occurring 3 weeks apart and 9 integrative sessions over the course of 10 weeks. These are followed by 12 sessions of BN-specific eating disorder psychotherapy.

MDMA-AT-BN

Standard Treatment (ST) BEHAVIORAL

Standard Treatment (ST) for BN assignment includes weekly therapy sessions for 22 weeks.

Standard Treatment (ST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included in the protocol if they meet the following criteria:
• At least 18 years of age
• Meet criteria for Bulimia Nervosa as measured by the EDA-5
• Able to provide written, informed consent
• Able to swallow pills
• Agree to have study visits recorded, including Experimental Sessions and non-medication therapy sessions
• Provides a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable
• Agrees to inform the investigators within 48 hours of any medical conditions and procedures
• If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraceptive methods through 10 days after the last Experimental Session. Adequate contraceptive methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). 'Not able to become pregnant' is defined as permanent sterilization, postmenopausal, or assigned male at birth
• Agrees to the lifestyle modifications
• Live within reasonable driving distance of the study site (equal to or less than an estimated 2-hour drive from the study site).
• Have an identified Primary Care Physician (PCP) and provide consent for the investigator to communicate with PCP, as needed.
• Current or past treatment were not successful to retain remission (i.e., continued to meet criteria for BN) despite participating in at least one ED-specific episode of treatment (inpatient, residential, partial hospitalization, intensive outpatient), as confirmed by medical records, by a general practitioner, or by a specialist in ED.
• Are medically stable according to screening 12-lead Electrocardiogram (ECG), blood pressure monitoring, blood and urine laboratory screening results, and medical history.

You may not qualify if:

• Participants will be excluded from participation for the following reasons:
• Alanine transaminase (ALT) \[or aspartate transaminase (AST)\] \> 2 x upper limit of normal (ULN). Total bilirubin \> 1.5 x ULN (isolated bilirubin \> 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin \< 35%).
• Estimated glomerular filtration rate (eGFR) less than 60.
• Current unstable liver or biliary disease per investigator assessment defined by presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (e.g., the presence of hepatitis B surface antigen or positive hepatitis C antibody test result without evidence of active infection at screening or within 3 months prior to starting study intervention) is acceptable if the participant otherwise meets entry criteria.
• Self-induced vomiting of over 14 times per week
• Symptomatic Hepatitis C virus (HCV)
• Moderate alcohol or cannabis use disorder (meets \> 3 of 11 diagnostic criteria per DSM-5) or moderate alcohol or cannabis use disorder in early remission for the 3 months prior to enrollment (meets 4 or 5 of 11 diagnostic criteria per DSM-5)
• Diabetes Type 1 or Unstable Type 2 Diabetes
• Untreated hypothyroidism
• Are likely, in the investigator's opinion and via observation during the Preparatory Period, to lack social support or a stable living situation
• Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session;
• Have previously participated in a MAPS-sponsored MDMA clinical trial
• Have any current problem which, in the opinion of the investigator or study clinician, might interfere with participation
• Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product)
• Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Bulimia Nervosa; Feeding and Eating Disorders; Bulimia

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia

Study Officials

• Tom Hildebrandt, PsyD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carson Harran

CONTACT

212-659-8724; carson.harran@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of the Division of Eating & Weight Disorders

Model Details: This is a clinical trial to evaluate MDMA-assisted therapy for the treatment of 40 individuals with Bulimia Nervosa comparing a BN-protocol, non-specific treatment protocol, and standard care, as measured by the estimate of change in objective bulimic episodes and in global severity of BN symptoms.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)