Oxytocin for Binge Eating Disorder

(STROBE Trial)

Overseen By Jordan Hillard

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Insulin

Disqualifiers: Substance use, Cardiovascular disease, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

Duration: 8 weeks

60 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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

BMI 30-50 kg/m2

BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV)

Exclusion 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.

Hematocrit >2% below normal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intranasal oxytocin or placebo for 8 weeks

8 weeks

Visits at Baseline, week 2, week 4, and week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Visit at week 16 (8 weeks post-treatment)

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin
• Placebo

Trial Overview

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.

How Is the Trial Designed?

Group I: TNX-1900 Experimental Treatment 1 Intervention

Solution with oxytocin

Group II: Placebo Arm Placebo Group 1 Intervention

Solution without oxytocin

Oxytocin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pitocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in European Union as Syntocinon for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in Canada as Oxytocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6187754/

Oxytocin and Eating Disorders: A Narrative Review on ...

We propose a framework of oxytocin's role and its therapeutic potential in eating disorders that aims at integrating social and metabolic aspects of its ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0306453023002688

Oxytocin and eating disorders: Knowledge gaps and future ...

The aim of this mini review is to collate recent findings on OT as a novel therapeutic intervention in eating disorders and obesity.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7853418/

Binge Eating Disorder: A 5-Year Retrospective Study on ...

Oxytocin, another important hormone receiving attention in the last years, seems to play a strong effect on food consumption. Besides its ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05664516

A Study of the Effects of Oxytocin in Adults With Binge ...

Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0303720718303678

The influence of oxytocin on eating behaviours and stress ...

64IU intranasal oxytocin did not impact eating in healthy women or women with bulimia nervosa or binge eating disorder.

6.

nationaleatingdisorders.org

nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery

Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0143417923000689

The use of intranasal oxytocin in the treatment of eating ...

Oxytocin (OXT) is a hypothalamic peptide that plays a number of roles in the body, being involved in labor and lactation, as well as cognitive-emotional ...

8.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05664516/a-study-of-the-effects-of-oxytocin-in-adults-with-obesity-and-binge-eating-disorder

A Study of the Effects of Oxytocin in Adults With Obesity ...

This study evaluates the impact of intranasal oxytocin vs placebo in patients with obesity and binge eating disorder with obesity.