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Hormone Therapy
Oxytocin for Adolescent Obesity
Phase 2
Recruiting
Led By Elizabeth Lawson, MD, MMSc
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and Females, 12-18 years
Obesity (BMI ≥95th percentile for age and gender)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trialtests if a nose spray can help youths with obesity by assessing appetite, behavior, metabolism, and hormones.
Who is the study for?
This trial is for overweight adolescents aged 12-18 with a BMI in the top 5% for their age and gender. They must be willing to keep their diet and lifestyle unchanged during the study. Those with certain medical conditions, significant recent weight changes, or on specific diets or medications that affect metabolism are excluded.Check my eligibility
What is being tested?
The study tests if oxytocin nasal spray helps with weight loss compared to a placebo. Participants will use either the real spray or placebo four times daily for three months, while researchers monitor appetite, behavior, metabolism, and hormones.See study design
What are the potential side effects?
Potential side effects of oxytocin may include temporary discomfort at the site of spraying such as runny nose or sneezing; more systemic effects could involve changes in mood or behavior but these are less common.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 18 years old.
Select...
My BMI is in the top 5% for my age and gender.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body mass index (BMI)
Height
Weight
Secondary outcome measures
Fasting Resting Energy Expenditure (kCal)
Lean mass and Fat mass
Side effects data
From 2019 Phase 1 & 2 trial • 23 Patients • NCT0311961058%
Dizziness
42%
Allergic Rhinitis
42%
Nausea
33%
Headache
17%
Nasal Irritation
17%
Sore Throat
17%
Lightheaded
8%
Neck Pain
8%
Bruise related to biopsy
8%
Confusion
8%
Skin Rash
8%
Sinus Disorder
8%
Anorexia
8%
Throat itching
8%
Muscle Aches
8%
Upset stomach
8%
Migraine
8%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Nasal Spray
Oxytocin Nasal Spray
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxytocinExperimental Treatment1 Intervention
Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Group II: PlaceboPlacebo Group1 Intervention
Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin nasal spray
2016
Completed Phase 4
~1490
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,566 Total Patients Enrolled
70 Trials studying Obesity
291,019 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,775 Total Patients Enrolled
103 Trials studying Obesity
25,781 Patients Enrolled for Obesity
Elizabeth Lawson, MD, MMScPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have an eating disorder that is not under control.You are following a specialized diet such as gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet.I have a thyroid condition that hasn't been treated.You agree to keep your current diet and lifestyle throughout the study.You have gained or lost more than 5 kilograms (11 pounds) of weight in the past three months.You are currently using drugs or alcohol excessively.I am between 12 and 18 years old.My diabetes is not well-controlled, with an HbA1c over 8%.I am not on any medication that affects my metabolism, except for stable use of Metformin.My BMI is in the top 5% for my age and gender.I have epilepsy.I am not pregnant or breastfeeding and agree to use non-estrogen contraception if I'm sexually active.I have a heart condition.I have a long-term stomach or bowel condition.I am currently taking oral contraceptive pills.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Oxytocin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the protocol for this trial include minors?
"According to the terms of this medical investigation, only individuals between 12 and 18 years old may be enrolled as participants."
Answered by AI
Could you assess the safety of Oxytocin nasal spray for patients?
"Oxytocin nasal spray is classified as a 2 on our scale of 1-3 - indicating some data exists backing its safety, but no evidence yet of efficacy."
Answered by AI
Is this research actively recruiting participants?
"Correct. The information on clinicaltrials.gov reveals that this medical experiment, initiated on July 28th 2021, is actively recruiting participants. 75 individuals are needed to be enrolled from a single location."
Answered by AI
What is the size of the cohort being studied in this trial?
"Affirmative. The clinical trial is currently underway and prospective participants can find details on clinicialtrials.gov. It was initially published in July 2021, with the most recent update recorded at the end of November 2022; 75 patients are being recruited at one site alone."
Answered by AI
Am I eligible to participate in this research endeavor?
"This medical trial requires the recruitment of 75 individuals between 12 and 18 years old who are dealing with obesity (BMI ≥95th percentile for age and gender). Furthermore, participants must be willing to retain their current lifestyle habits over the course of this research. Both males and females qualify."
Answered by AI
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