RecruitingPhase 2NCT05664516

A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder

Sponsor

Massachusetts General Hospital

Enrollment

60 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Binge-Eating Disorder

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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 Criteria19

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; epilepsy; untreated thyroid disease
History of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT
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