Actively Recruiting
A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
Led by Massachusetts General Hospital · Updated on 2025-11-18
60
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 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.
CONDITIONS
Official Title
A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years
- Body mass index (BMI) of at least 18.5
- Diagnosis of binge-eating disorder (BED), other specified feeding or eating disorder (OSFED) with binge-eating, or bulimia nervosa (BN) involving excessive exercise or fasting to avoid weight gain after binge episodes
- For OSFED-BED, binge eating frequency must meet criteria for BED
You will not qualify if you...
- Active substance use disorder within the past 6 months or suspected ongoing substance use disorder
- Recent medication changes not at steady state (less than 5 half-lives)
- Unstable use of medications for binge eating disorder or weight loss (less than 12 weeks stable dose)
- History of inflammatory bowel disease, epilepsy, or untreated thyroid disease
- History of cardiovascular disease including coronary artery disease, heart failure, cardiomyopathy, arrhythmias, or prolonged QT
- Hematocrit more than 2% below normal
- Hemoglobin A1c greater than 8%
- Use of insulin
- Liver enzymes (ALT or AST) more than 2.5 times the upper limit of normal
- Glomerular filtration rate below 60 mL/min
- Low sodium levels (less than 135 mEq/L)
- Pregnancy or breastfeeding
- Unwillingness to use medically acceptable contraception if female of childbearing potential
- History of psychosis or active suicidal thoughts
- Major depressive disorder requiring new or changed treatment
- Borderline personality disorder
- Current nicotine use unless stable for at least 12 weeks
- Participation in any clinical trial with investigational treatment within 1 month
- Any illness or condition that could interfere with study participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Neuroendocrine Unit Research Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Lauren Shabazian, NP
CONTACT
J
Jordan Hillard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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