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New treatment option for Bulimia Nervosa
Official title MDMA Assisted Therapy for BN
ClinicalTrials.gov ID: NCT07542145
What this study is testing
What is MDMA-AT?
MDMA-AT is an investigational medicine, given as an once-weekly, being studied as a potential treatment for bulimia nervosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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 \>...
- 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...
- Self-induced vomiting of over 14 times per week
- Symptomatic Hepatitis C virus (HCV)
See the full eligibility criteria
Who can 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
- 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...
- 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...
- Are medically stable according to screening 12-lead Electrocardiogram (ECG), blood pressure monitoring, blood and urine laboratory screening results, and medical history.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.