Overview
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
Description
Study staff will screen patients for eligibility as per eligibility criteria. At least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. All other study staff and test subjects will be blinded. Study subject medical histories, physical exams, anthropometric measurements, labs, EKG's, and eating habits will be monitored over 8 weeks. Subjects will be evaluated at the following intervals: Baseline, week 2, week 4, and week 8.
Eligibility
Inclusion Criteria:
- Males and females, 18-45 years old
- BMI 30-50 kg/m2
- BED 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 results
- Medication changes within 4 weeks of baseline visit
- Use 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 months
- History 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 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%
- ALT or AST >2.5 times upper limit of normal
- Glomerular filtration rate < 60 mL/min
- Hyponatremia
- 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 suicidality as assessed by the SCID-5-RV
- Weight change >5 kg within 3 months prior to randomization
- Current smoking or tobacco use
- 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 patient safety