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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion Criteria:

1. Males and females, 18-45 years old

2. BMI 30-50 kg/m2

3. BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV)

Exclusion Criteria:

1. 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

2. Medication changes within 4 weeks of baseline visit

3. 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

4. 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

5. History of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT

6. Hematocrit >2% below normal

7. Hemoglobin A1c >8%

8. ALT or AST >2.5 times upper limit of normal

9. Glomerular filtration rate < 60 mL/min

10. Hyponatremia

11. Pregnancy or breastfeeding

12. Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)

13. History of psychosis or active suicidality as assessed by the SCID-5-RV

14. Weight change >5 kg within 3 months prior to randomization

15. Current smoking or tobacco use

16. Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization

17. Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or patient safety