Purpose

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18-45 years old; - BMI greater than or equal to 30 kg/m2

Exclusion Criteria

  • Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months); - history of medication changes within 4 weeks of enrollment; - active substance use; - history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease; - hematocrit >2% below normal; - fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ; - ALT or AST >2.5 times upper limit of normal; - Cr >1.5 mg/dL; hyponatremia; - pregnancy or breastfeeding; - unwilling to use medically acceptable form of contraception (females only) - follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet) - current smoking or tobacco use

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
oxytocin
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
  • Drug: oxytocin nasal spray
    oxytocin intranasal spray
    Other names:
    • Syntocinon
Placebo Comparator
placebo
placebo nasal spray (4 times per day for 8 weeks)
  • Drug: Placebo
    Placebo nasal spray

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.