What side effects are associated with this type of intervention?

Common treatments for Binge Eating Disorder (BED) include cognitive-behavioral therapy (CBT), medications such as selective serotonin reuptake inhibitors (SSRIs), and emerging treatments like intranasal oxytocin. CBT is generally well-tolerated but may cause temporary emotional discomfort as patients confront their eating behaviors. SSRIs can cause side effects such as nausea, insomnia, and sexual dysfunction. Intranasal oxytocin, which is being studied for its potential to influence appetite and impulse control, has shown a satisfactory safety and tolerability profile in preliminary studies, though some individuals may experience mild side effects like nasal irritation or headaches.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Binge Eating Disorder (BED). One notable example is lisdexamfetamine dimesylate (Vyvanse), which is a stimulant that affects neurotransmitters in the brain to help control impulses and reduce binge eating episodes. Other treatments that have been explored include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, which can help manage the emotional and behavioral aspects of BED. These treatments aim to modulate appetite, reward sensitivity, and impulse control, similar to the hypothesized effects of intranasal oxytocin.

What other types of research exist?

Promising alternatives to intranasal oxytocin for treating binge eating disorder in 2024 include: 1) Naltrexone/Bupropion combination therapy, which has shown efficacy in weight loss and managing obesity-related risk factors by influencing reward pathways and impulse control. 2) Naloxone, an opiate blocker, which has been effective in reducing the consumption of sweet high-fat foods in binge eaters. 3) Deep Brain Stimulation (DBS) targeting the ventral internal capsule/ventral striatum, which has shown promise in treating refractory obsessive-compulsive disorder and may influence reward sensitivity and impulse control.

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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

Awards & highlights

STROBE Trial Summary

This trial studies the effects of oxytocin vs. placebo on weight loss and binge eating in patients with obesity. We hope to see positive changes in appetite, reward, and impulse control.

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.Check my eligibility

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.See study design

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.

STROBE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

weight (kg)

Secondary outcome measures

Binge Frequency

STROBE 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

Do I qualify?Apply below to find out

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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,943 Previous Clinical Trials

13,200,889 Total Patients Enrolled

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05664516 — Phase 2

Binge Eating Disorder Research Study Groups: Placebo Arm, TNX-1900

Binge Eating Disorder Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT05664516 — Phase 2

Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664516 — Phase 2

~28 spots leftby May 2025

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