Oxytocin for Binge Eating Disorder
(STROBE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a nasal spray containing oxytocin can help individuals with binge eating disorder or episodes of binge eating. Researchers aim to determine if using oxytocin for eight weeks reduces binge eating frequency compared to a placebo, which contains no oxytocin. The study also seeks to understand how changes in appetite, reward sensitivity, and impulse control might predict treatment success. Eligible participants have experienced binge eating episodes and may use excessive exercise or fasting to control weight after binging. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you must stop taking your current medications, but you need to be on a stable dose of any medications for binge eating disorder or weight loss for at least 12 weeks. Also, any medication changes should have reached a steady state, which means no recent changes in dosage.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intranasal oxytocin is usually safe for people. It plays a role in various body functions, such as childbirth and emotions. Oxytocin has been tested as a treatment for conditions like obesity and binge eating disorder. These studies found that most people tolerate oxytocin well without serious issues. Some minor side effects, such as a stuffy nose or headache, have been noted, but they are uncommon. As this trial is in the early stages, researchers are carefully monitoring its safety. Overall, the safety record appears positive, but more research is needed to fully understand its effects.12345
Why do researchers think this study treatment might be promising for binge eating disorder?
Unlike traditional treatments for binge eating disorder, which often involve cognitive behavioral therapy and medications like antidepressants, the investigational treatment uses oxytocin, a hormone known for its role in social bonding and stress reduction. Researchers are excited about this treatment because oxytocin may target the underlying emotional triggers of binge eating, offering a new mechanism of action. By potentially influencing the brain's reward system and emotional regulation, it could provide relief for patients who do not respond well to current options.
What evidence suggests that oxytocin might be an effective treatment for binge eating disorder?
Research has shown that oxytocin, which participants in this trial may receive, might help reduce food intake, potentially aiding in the treatment of binge eating disorder. Oxytocin appears to influence both social and body-related factors associated with eating disorders. However, some studies found no change in eating habits among certain women with binge eating disorder. This mixed evidence suggests that while oxytocin holds promise, its effectiveness remains under investigation. The treatment is considered safe, but further research is necessary to confirm its ability to reduce binge eating episodes. Participants in this trial may also receive a placebo, serving as a control to better understand oxytocin's effects.23678
Who Is on the Research Team?
Elizabeth A Lawson, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Adults aged 18-45 with obesity (BMI between 30-50) and diagnosed binge eating disorder can join. They mustn't have had medication changes recently, significant illnesses, or be using substances. Women who can get pregnant should use contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intranasal oxytocin or placebo for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oxytocin
- Placebo
Oxytocin is already approved in United States, European Union, Canada for the following indications:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor