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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

MDMA Assisted Therapy for BN

MDMA Assisted Therapy for Bulimia Nervosa: A Treatment Development Protocol

MDMA Assisted Therapy for BN (NCT07542145) is a Phase 1 interventional studying Bulimia Nervosa, sponsored by Icahn School of Medicine at Mount Sinai. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Bulimia Nervosa, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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, willing to sign a consent form - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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. Exclusion Criteria: 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 * 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

Treatments Being Tested

DRUG

MDMA-AT

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.

DRUG

MDMA-AT-BN

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.

BEHAVIORAL

Standard Treatment (ST)

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07542145), the sponsor (Icahn School of Medicine at Mount Sinai), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07542145 clinical trial studying?

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 f… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07542145?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07542145?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07542145. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07542145. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.