Clinical trial NCT05664516: A Study of the Effects of Oxytocin in Adults With Obesity and Binge-eating Disorder
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Obesity and Binge- Eating Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Binge-eating Disorder
Keywords: Obesity
Weight Loss
Binge
Binge-eating disorder
Oxytocin
Overeating
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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 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

Primary outcomes:
measure: weight (kg)
timeFrame: 8 weeks
Secondary outcomes:
measure: Binge Frequency
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Neuroendocrine Unit Research Center
state: Massachusetts
Study officials:
References: