RecruitingPhase 2NCT05664516

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

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder


Sponsor

Massachusetts General Hospital

Enrollment

60 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study evaluates the impact of intranasal oxytocin vs placebo in patients with binge eating disorder or episodes of binging. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes \[reduction in bingeing frequency\], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called TNX-1900 (Tonix Pharmaceuticals) for people with binge-eating disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTNX-1900 (Tonix Pharmaceuticals)

oxytocin nasal spray

DRUGPlacebo

Nasal solution without oxytocin


Locations(1)

Neuroendocrine Unit Research Center

Boston, Massachusetts, United States

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NCT05664516


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