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

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