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Bulimia NervosaPhase 1NCT07542145

MDMA Assisted Therapy for BN

A Phase 1 study testing MDMA-AT, MDMA-AT-BN and Standard Treatment (ST) in people with Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bulimia Nervosa
What is being tested?
MDMA-AT, MDMA-AT-BN and Standard Treatment (ST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
22 May 2026to 30 Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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
  • Have a history of or a current primary psychotic disorder, bipolar disorder 1 assessed via CAT-MH and confirmed via clinical interview or dissociative identity disorder assessed via DDIS and confirmed via clinical interview
  • Have current major depressive disorder with psychotic features assessed via CAT-MH
  • Have a current moderate (not in early remission in the 3 months prior to enrollment; meets 4 or 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 12 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5)
  • Have an active illicit drug or prescription drug substance use disorder at any severity (other than cannabis) within 12 months prior to enrollment
  • Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled. Any participant presenting with the following on the Baseline C-SSRS will be excluded: a. Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more; b. Suicidal ideation score of 5 within the last 6 months of the assessment; c. Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self-injurious behavior may be included if approved by the study clinician
  • Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist
  • Require ongoing concomitant therapy with a psychiatric medication with exceptions described the Concomitant Medications Section
  • Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, or aneurysm. Participants with other mild, stable chronic medical problems may be enrolled if the study physician and Sponsor-investigator agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP. Examples of stable medical conditions that could be allowed include, but are not limited to Diabetes Mellitus (Type 2), Human Immunodeficiency Virus (HIV) infection, Gastroesophageal Reflux Disease (GERD), etc. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism would require exclusión
  • ASCVD Risk Estimator 10-year cardiovascular risk of 7.5% or higher
  • Duke Activity Status Index (DASI) METs score less than 4
  • Have a diagnosis of uncontrolled essential hypertension which is assessed using the recommended criteria of the American Heart Association for Stage 2 hypertension (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions)
  • Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease
  • Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation
  • Have a history of supraventricular arrhythmia within the last 12 months. Participants with a history of an allowable supraventricular arrhythmia (see list below) more than 12 months prior to screening and in the absence of any accessory pathway may be enrolled if successfully treated at least 12 months prior and cleared by a cardiologist, and the study clinician. These arrhythmias may include, and must be limited to, paroxysmal supraventricular tachycardia, paroxysmal atrial tachycardia, or atrial fibrillation that has been successfully treated (e.g., with ablation or cardioversion) at least 12 months previously. Atrial flutter or other arrhythmias will be excluded
  • Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF interval >450 milliseconds [ms]
  • Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions. Refer to Concomitant Medications Section
  • Have history of hyponatremia or hyperthermia
  • Weigh less than 48 kilograms (kg)
  • Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception
  • Have a blood or needle phobia that interferes with obtaining necessary blood work.
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study.
  • Expressed that they are not comfortable in participating in therapy and conducting assessments in English.
  • Blood disorder or infection indicated by CBC assay that would be contraindicated for MDMA.
  • Thyroid condition (hyperthyroidism) indicated by TSH that would prevent body temperature regulation and be contraindicated for MDMA
  • Urinalysis results indicating electrolytes/kidney disfunction

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carson Harran contact

212-659-8724

carson.harran@mssm.edu

United States1 site, 1 recruiting

  • Department of Psychiatry, Eating and Weight Disorders Program

    New York, New York, 10028

    Carson Harran, 212-659-8724, carson.harran@mssm.edu

    Tom Hildebrandt

    Recruiting

Other trials in United States

About this study

Official title: MDMA Assisted Therapy for Bulimia Nervosa: A Treatment Development Protocol

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.

Read the detailed description

Three groups (MDMA-AT, MDMA-AT-BN, and ST) will be compared on changes in Binge Eating frequency, severity of symptoms, body image, weight, retention, acceptability of treatment, motivation, and safety. Assessments include a screening phase, baseline, MDMA-preparation phase, intervention, and a follow-up. MDMA-AT includes 3 sessions of MDMA-assisted psychotherapy, 9 integrative sessions that involve discussing the experiences during MDMA sessions and processing thoughts, emotions, and distress. Additionally, 12 weekly non-specific therapy sessions take place after the dosing and integrative sessions. MDMA-AT-BN includes the same visits, but the psychotherapy is specific to BN. ST includes 22 weekly sessions focusing on thoughts and behaviors related to BN. A final follow-up visit will take place 6-months after baseline.

Conditions
Bulimia Nervosa
Being tested
MDMA-AT, MDMA-AT-BN, Standard Treatment (ST)
Keywords
Bulimia Nervosa, MDMA-assisted therapy, Eating Disorders, Binge Eating, BN
Medical subject headings
Bulimia Nervosa, Feeding and Eating Disorders, Bulimia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDMA-ATDrug

    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-BNDrug

    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.

  • Standard Treatment (ST)Behavioural

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

Study groups in NCT07542145
Study groupRoleWhat they receive
MDMA-ATExperimentalThis 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.
Receives: Drug: MDMA-AT
MDMA-AT-BNExperimentalThis 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.
Receives: Drug: MDMA-AT-BN
Standard Treatment (ST)Active comparatorThis assignment includes weekly therapy sessions for 22 weeks.
Receives: Behavioral: Standard Treatment (ST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 months

Secondary outcomes (1)

  1. Binge Eating Severity

    Eating Disorder Examination Questionnaire (EDEQ) is a self-report measure assessing psychopathology of eating disorders using 28 items. Global score ranges from 0 to 6 with higher scores indicating symptoms of higher severity. Scores will be calculated between baseline and 6-months.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study start22 May 2026
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07542145
Sponsor's protocol ID
STUDY-23-00894
Status last verified
Jun 2026
First submitted
14 Apr 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared from this trial due to the early stages of investigation.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDMA-AT, MDMA-AT-BN and Standard Treatment (ST) in people with Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carson Harran (212-659-8724, carson.harran@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binge Eating Episode Frequency (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07542145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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