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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05664516
Phase
PHASE2
Status
Recruiting
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Conditions

  • Binge-eating Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TNX-1900 (Tonix Pharmaceuticals) — DRUG
    oxytocin nasal spray
  • Placebo — DRUG
    Nasal solution without oxytocin

Study Details

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.

Key Dates

Start date
Mar 7, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Arm
    Solution without oxytocin
  • Experimental: TNX-1900
    Solution with oxytocin

Primary Outcome Measure

Binge Frequency [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Neuroendocrine Unit Research CenterBostonMassachusetts02114
Lauren Shabazian, MSN
[email protected]
Jordan Hillard

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By research site
Neuroendocrine Unit Research Center· Boston, MA

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