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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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,295 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to take part in this medical experiment?

"The current clinical trial requires participants to have been officially diagnosed with binge eating disorder, and must be between 18-45 years old. Around 60 people are needed to complete the study."

Answered by AI

Is the research study still open for enrolment?

"As evident from clinicaltrials.gov, this medical trial is now looking for volunteers to participate. The research study was first advertised on March 7th 2023 and has had its parameters amended recently on March 22nd 2023."

Answered by AI

Does this trial include individuals in the geriatric age range?

"This clinical trial is only available to patients between 18 and 45 years of age. However, there are an abundance of other trials with different eligibility criteria such as 473 studies for minors and 1,273 targeted towards the elderly."

Answered by AI

Has the FDA sanctioned TNX-1900 for public use yet?

"TNX-1900's safety was rated 2 on a scale from 1 to 3, as the drug has yet to be proven effective but there is some evidence of its safety."

Answered by AI

What is the upper limit of participants taking part in this clinical trial?

"Affirmative. As per the information on clinicaltrials.gov, this medical study is actively enrolling patients and was posted on March 7th 2023 with an update made to it recently on March 22nd 2023. Sixty participants are being sought across one location specifically for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Effects of Oxytocin in Adults With Obesity and Binge-eating Disorder

Elizabeth Austen Lawson 2023. "A Study of the Effects of Oxytocin in Adults With Obesity and Binge-eating Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05664516.

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