A Study of the Effects of Oxytocin in Adults With Obesity and Binge-eating Disorder (STROBE)
Binge-eating Disorder
About this trial
This is an interventional treatment trial for Binge-eating Disorder focused on measuring Obesity, Weight Loss, Binge, Binge-eating disorder, Oxytocin, Overeating
Eligibility Criteria
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
Sites / Locations
- Neuroendocrine Unit Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo Arm
TNX-1900
Solution without oxytocin
Solution with oxytocin