NCT05664516

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study staff will screen patients for eligibility as per eligibility criteria. At least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. All other study staff and test subjects will be blinded. Study subject medical histories, physical exams, anthropometric measurements, labs, EKG's, and eating habits will be monitored over 8 weeks. Subjects will be evaluated at the following intervals: Baseline, week 2, week 4, week 8, and week 16 (8 weeks post-treatment).

Conditions

• Binge-eating Disorder

Interventions

Type	Name	Description
DRUG	TNX-1900 (Tonix Pharmaceuticals)	oxytocin nasal spray
DRUG	Placebo	Nasal solution without oxytocin

Timeline

• Start date: 2023-03-07
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-12-23
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study