NCT05664516 · Massachusetts General Hospital
A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
(STROBE)
What this study is about
This study evaluates the impact of intranasal oxytocin vs placebo in patients with binge eating disorder or episodes of binging. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes \[reduction in bingeing frequency\], and have a satisfactory safety and how well patients handle the treatment profile.
View original scientific description
This study evaluates the impact of intranasal oxytocin vs placebo in patients with binge eating disorder or episodes of binging. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes \[reduction in bingeing frequency\], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and females, 18-70 years old
- BMI greater than or equal to 18.5
- BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) OR Other Specified Feeding or Eating Disorder (OSFED) - Binge-eating disorder (of low frequency and/or limited duration) (SCID-5-RV) OR Bulimia Nervosa (BN) through excessive exercise and/or fasting to avoid gaining weight after episodes of binge eating. For individuals with OSFED-BED, the frequency of subjective and objective binge eating episodes will meet the frequency (Criterion D) for BED.
Exclusion criteria
- Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results
- Medication changes that have not reached steady state concentration, measured by the equivalent of 5 half-lives of that medication
- Use of medications for binge eating disorder or weight loss unless at a stable dose for at least 12 weeks
- History of any of the following medical conditions: inflammatory bowel disease or untreated thyroid disease
- Uncontrolled epilepsy (as defined by a seizure within the last 12 months)
- Clinically relevant ventricular arrhythmias, coronary heart disease, known long QTc, and hypertrophic cardiomyopathy
- Hematocrit \>2% below normal
- Hemoglobin A1c \>8%
- Use of insulin
- ALT or AST \>2.5 times upper limit of normal
- Glomerular filtration rate \< 60 mL/min
- Hyponatremia. Note that, in order to be randomized, subjects must have Na ≥ 135 mEq/L.
- Pregnancy or breastfeeding
- Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
- History of psychosis or active suicidal ideation
- Major depressive disorder likely to require initiation or change in active treatment
- Borderline personality disorder as assessed by the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD)
- Current nicotine use, unless stable use for at least 12 weeks.
- Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization
- Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or subject safety
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations