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Hormone Therapy
Oxytocin for Binge Eating Disorder (STROBE Trial)
Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Summary
This trial uses a nasal spray with oxytocin to help people who are obese and have binge eating disorder. The hormone may reduce hunger, decrease binge eating urges, and improve self-control. Oxytocin has been shown to reduce caloric intake in humans and induce weight loss in animal models of obesity.
Who is the study for?
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.
What is being tested?
The trial is testing TNX-1900 (intranasal oxytocin) against a placebo in adults with obesity and binge eating disorder over 8 weeks to see if it helps reduce weight and bingeing frequency while being safe and tolerable.
What are the potential side effects?
While not specified here, intranasal oxytocin could potentially cause nasal irritation, headaches, emotional changes or imbalances since it's related to social bonding hormones.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
weight (kg)
Secondary study objectives
Binge Frequency
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TNX-1900Experimental Treatment1 Intervention
Solution with oxytocin
Group II: Placebo ArmPlacebo Group1 Intervention
Solution without oxytocin
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Binge Eating Disorder (BED) include behavioral therapies, pharmacotherapy, and emerging treatments like intranasal oxytocin. Behavioral therapies, such as Cognitive Behavioral Therapy (CBT), work by addressing dysfunctional beliefs and behaviors, improving impulse control, and managing emotional triggers.
Pharmacotherapy, including medications like antidepressants and appetite suppressants, aims to reduce binge eating episodes by modulating neurotransmitter levels and appetite. Intranasal oxytocin, currently under study, may influence social and emotional behaviors, appetite, reward sensitivity, and impulse control, potentially reducing binge eating frequency.
These treatments are crucial for BED patients as they target the underlying psychological and physiological mechanisms driving the disorder, offering a comprehensive approach to management and improving clinical outcomes.
Progress in Personalized Psychiatric Therapy with the Example of Using Intranasal Oxytocin in PTSD Treatment.The ABBA study - approach bias modification in bulimia nervosa and binge eating disorder: study protocol for a randomised controlled trial.Diagnosis and management of binge eating disorder.
Progress in Personalized Psychiatric Therapy with the Example of Using Intranasal Oxytocin in PTSD Treatment.The ABBA study - approach bias modification in bulimia nervosa and binge eating disorder: study protocol for a randomised controlled trial.Diagnosis and management of binge eating disorder.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,889 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of inflammatory bowel disease, bariatric surgery (except laparoscopic adjustable gastric band), epilepsy, or untreated thyroid disease.I have a history of heart disease.My kidney function is reduced.I don't have any health issues that could affect my study participation.I am between 18 and 45 years old.I am not taking weight loss drugs except for Metformin, which I've been on for 3+ months with stable weight.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: TNX-1900
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.