Oxytocin Nasal Spray for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether an oxytocin nasal spray can aid in weight management for obese adults. Oxytocin, a hormone, might influence weight by affecting behaviors and metabolism. Participants will receive either the oxytocin spray or a placebo to compare results. This trial may suit individuals with a BMI of 30 or higher who haven't recently changed medications or diets. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications that affect metabolism, glucose, or appetite, except for Metformin if your dose and weight have been stable for at least 3 months. If you've changed medications in the last 4 weeks, you may not be eligible.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that using oxytocin as a nasal spray is generally safe. A review of 38 studies found that most did not report serious side effects. Some studies mentioned rare issues like aggression and seizures, but these also occurred in placebo groups. Another study found no major problems with doses between 24 to 72 IU, suggesting that oxytocin is well-tolerated by most people. However, as with any treatment, risks exist, so discussing any concerns with a doctor is important.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for obesity, which often include lifestyle changes and medications that target metabolism or appetite, oxytocin nasal spray offers a novel approach by leveraging the hormone oxytocin, known for its role in social bonding and appetite regulation. Researchers are excited about oxytocin because it may help reduce food intake and promote weight loss through its unique mechanism of action on the brain, potentially offering an alternative for individuals struggling with obesity. Additionally, the nasal spray delivery method is non-invasive and convenient, making it easy for users to incorporate into their daily routines.
What evidence suggests that intranasal oxytocin could be an effective treatment for obesity?
Research has shown that intranasal oxytocin, which participants in this trial may receive, offers potential benefits, particularly in reducing stress and enhancing social interactions. One study found that a 24 IU dose of intranasal oxytocin significantly lowered stress levels when individuals felt judged by others. Another study demonstrated improvements in social skills, such as better eye contact. However, not all studies have found it more effective than a placebo for other outcomes. While oxytocin shows promise in certain areas, its effectiveness can vary depending on the situation. Participants in this trial may receive either the oxytocin nasal spray or a placebo nasal spray.678910
Who Is on the Research Team?
Elizabeth A Lawson, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
A 2-part baseline visit to establish initial measurements and conditions
Treatment
Participants receive intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oxytocin Nasal Spray
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor