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

This study evaluates the impact of intranasal oxytocin vs placebo in patients with obesity and binge eating disorder with obesity. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes [weight loss, 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

Inclusion Criteria:Males and females, 18-45 years oldBMI 30-50 kg/m2BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV)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 resultsMedication changes within 4 weeks of baseline visitUse of prescription or over-the-counter drugs or dietary/herbal supplements for weight loss (e.g., lorcaserin, phentermine, topiramate, liraglutide). Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 monthsHistory of any of the following medical conditions: inflammatory bowel disease; bariatric surgery (except for those participants with a history of laparoscopic adjustable gastric band surgery); epilepsy; untreated thyroid diseaseHistory of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QTHematocrit >2% below normalHemoglobin A1c >8%ALT or AST >2.5 times upper limit of normalGlomerular filtration rate < 60 mL/minHyponatremiaPregnancy or breastfeedingUnwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)History of psychosis or active suicidality as assessed by the SCID-5-RVWeight change >5 kg within 3 months prior to randomizationCurrent smoking or tobacco useParticipation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomizationAny significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or patient safety