Oxytocin for Weight Loss in Adolescents

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-18
SponsorMassachusetts General Hospital

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

55 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator