Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
10 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
55 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for teenagers aged 10 to 18 who are struggling with obesity. Participants will receive either oxytocin or a placebo nasal spray, taken four times a day for 12 weeks, while attending regular study visits and assessments.
Are You a Good Fit for This Trial?
Rules you outProlonged QT intervalChronic inflammatory bowel diseaseTSH > 2.5 times normal limitALT or AST > 2.5 times normal limitCreatinine > 1.5 mg/dlHyponatremiaType 1 Diabetes MellitusType 2 Diabetes Mellitus if HbA1c > 8%
You may be able to join if
I am between 10 and 18 years old.
I have obesity.
I am willing to maintain my current diet and lifestyle during the study.
You may not be able to join if
I have current substance abuse issues.
I have lost more than 5 kg in the last 3 months.
I follow a nonstandard diet.
I have cardiovascular disease.
I have epilepsy.
I am pregnant or breastfeeding, or I refuse to use contraception.
I have an eating disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Current substance abuse
* Use of prescription or over-the-counter drugs or di…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* Cardiovascular disease
* Prolonged QT interval
* Chronic inflammatory bowel disease and other inflammatory conditions
* Epilepsy
* TSH \> 2.5 times upper limit of normal
* Alanine transaminase (ALT) or aspartate transaminase (AST) \>2.5 times upper limit of normal
* Creatinine \>1.5 mg/dl
* Hyponatremia
* Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
* MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips
* Weight \>450 lbs due to limits for MRI and DXA scanners
* Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c \>8%
* Active eating disorder
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