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

Description

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

Conditions

Binge-eating Disorder

Study Overview

Study Details

Study 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

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Obesity and Binge- Eating Disorder

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

Condition
Binge-eating Disorder
Intervention / Treatment

-

Contacts and Locations

Boston

Neuroendocrine Unit Research Center, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Study Record Dates

2024-04