About this trial
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.
Eligibility criteria
Qualifiers
Males and Females, 10-18 years
Obesity (BMI ≥95th percentile for age and gender)
Willingness to maintain current diet and lifestyle for the duration of study participation
Disqualifiers
Current substance abuse
Use of prescription or over-the-counter drugs or dietary/herbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and/or if they plan to increase the dose during the 18 weeks of study participation.
Greater than 5kg weight loss over 3 months;
Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet)
Trial design
Treatments tested in this trial
- Oxytocin nasal spray
- Placebo
Treatment groups
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator