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

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) OROther Specified Feeding or Eating Disorder (OSFED) - Binge-eating disorder (of lowfrequency and/or limited duration) (SCID-5-RV) OR Bulimia Nervosa (BN) throughexcessive exercise and/or fasting to avoid gaining weight after episodes of bingeeating. For individuals with OSFED-BED, the frequency of subjective and objectivebinge eating episodes will meet the frequency (Criterion D) for BED.

Exclusion Criteria:

• Substance use disorder active within the last 6 months, or clinical suspicion ofongoing substance use disorder at the discretion of the study clinician at the timeof screening based on history and/or laboratory results

• Medication changes that have not reached steady state concentration, measured by theequivalent of 5 half-lives of that medication

• Use of medications for binge eating disorder or weight loss unless at a stable dosefor at least 12 weeks

• History of any of the following medical conditions: inflammatory bowel disease oruntreated 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 ≥ 135mEq/L.

• Pregnancy or breastfeeding

• Unwilling to use a medically acceptable form of contraception throughout the studyperiod (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 forBorderline 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, orbiologic within 1 month of randomization

• Any significant illness, condition, or medication that the Investigator determinescould interfere with study participation and impact data collection or subjectsafety