Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder
Led by Massachusetts General Hospital · Updated on 2026-05-28
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of intranasal oxytocin compared to a placebo in adults diagnosed with binge-eating disorder or episodes of bingeing. The study aims to see if 8 weeks of oxytocin treatment can reduce the frequency of binge episodes and assess its safety and tolerability. Additionally, the study will explore how changes in appetite control, reward sensitivity, and impulse control after 4 weeks may predict treatment success by week 8. At least 60 eligible adults will be randomly assigned to receive either oxytocin nasal spray or a placebo nasal solution without oxytocin in a double-blind setup. Participants will use the assigned nasal spray for 8 weeks. The study includes an 8-week treatment period followed by an 8-week post-treatment observation phase. Evaluations occur at baseline, week 2, week 4, week 8, and week 16 to monitor progress and effects. Throughout the study, participants will undergo medical history reviews, physical exams, body measurements, lab tests, EKGs, and assessments of eating habits. Researchers will measure binge frequency as the primary outcome at 8 weeks, along with reward sensitivity and impulse control as secondary outcomes. Follow-up visits at week 16 will help assess any lasting effects after treatment ends, ensuring thorough safety monitoring and data collection over the total study period.
CONDITIONS
Brief Title
A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 70 years
- Body mass index (BMI) of 18.5 or higher
- Diagnosis of binge-eating disorder by clinical interview or related eating disorders including low frequency binge eating or bulimia nervosa with excessive exercise or fasting
You will not qualify if you...
- Active substance use disorder within the last 6 months or suspected ongoing substance use
- Recent medication changes not at steady state
- Use of medications for binge eating or weight loss unless stable for at least 12 weeks
- History of inflammatory bowel disease or untreated thyroid disease
- Uncontrolled epilepsy with seizure within last 12 months
- Heart conditions including ventricular arrhythmias, coronary heart disease, long QTc, or hypertrophic cardiomyopathy
- Low hematocrit or high hemoglobin A1c above 8%
- Use of insulin
- Elevated liver enzymes (ALT or AST more than 2.5 times normal)
- Reduced kidney function with glomerular filtration rate below 60 mL/min
- Low sodium levels below 135 mEq/L
- Pregnancy or breastfeeding
- Unwillingness to use contraception if female and of child-bearing potential
- History of psychosis or active suicidal thoughts
- Major depressive disorder needing treatment change
- Borderline personality disorder
- Current nicotine use unless stable for 12 weeks
- Recent participation in any clinical study within 1 month
- Any other significant illness or condition that may interfere with study participation or safety
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either oxytocin nasal spray or placebo and are monitored for effects on binge-eating disorder.
Visits at baseline, week 2, week 4, and week 8
Duration - 8 weeks post-treatment
Participants are monitored for ongoing effects after treatment ends.
1 visit at week 16
Trial Site Locations
Total: 1 location
1
Neuroendocrine Unit Research Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Lauren Shabazian, NP
J
Jordan Hillard
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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