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RECRUITING
NCT05664516
PHASE2

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-03-07

Completion Date

2026-12

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DRUG

TNX-1900 (Tonix Pharmaceuticals)

oxytocin nasal spray

DRUG

Placebo

Nasal solution without oxytocin

Locations (1)

Neuroendocrine Unit Research Center

Boston, Massachusetts, United States