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A Study of Oxytocin Nasal Spray for Binge-eating Disorder

This study is looking at how an oxytocin nasal spray, called TNX-1900, affects adults with binge-eating disorder (BED) or similar eating patterns. Researchers want to see if using TNX-1900 for 8 weeks can reduce how often people binge eat compared to a placebo (a nasal spray without oxytocin). You might be able to join if you are between 18 and 70 years old, have a BMI of 18.5 or higher, and have been diagnosed with BED or a related eating disorder. The study aims to find out if TNX-1900 is safe and helps reduce binge eating. The current recruitment status is unclear.

Study design
This is an interventional study where 60 participants will be randomly assigned to receive either TNX-1900 or a placebo, with most staff and participants not knowing which they are receiving.
What's involved
You would have medical histories, physical exams, measurements, lab tests, EKGs, and eating habits monitored at baseline, week 2, week 4, week 8, and week 16.
Compensation
Not stated in the trial record.
Follow-up
Participants will be evaluated at week 16, which is 8 weeks after the treatment period ends.

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NCT05664516

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Massachusetts General Hospital
~60 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:TNX-1900 (Tonix Pharmaceuticals)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Binge Frequency
Measured over 8 weeks

Conditions

Binge-eating Disorder

Explore related trials

Binge EatingBulimia Nervosa

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Elizabeth A Lawson, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Lauren Shabazian, NP
[email protected]
617-726-0047
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males and females, 18-70 years old
BMI greater than or equal to 18.5
BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) OR Other Specified Feeding or Eating Disorder (OSFED) - Binge-eating disorder (of low frequency and/or limited duration) (SCID-5-RV) OR Bulimia Nervosa (BN) through excessive exercise and/or fasting to avoid gaining weight after episodes of binge eating. For individuals with OSFED-BED, the frequency of subjective and objective binge eating episodes will meet the frequency (Criterion D) for BED.

Exclusion

Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results
Medication changes that have not reached steady state concentration, measured by the equivalent of 5 half-lives of that medication
Use of medications for binge eating disorder or weight loss unless at a stable dose for at least 12 weeks
History of any of the following medical conditions: inflammatory bowel disease or untreated thyroid disease
Uncontrolled epilepsy (as defined by a seizure within the last 12 months)
Clinically relevant ventricular arrhythmias, coronary heart disease, known long QTc, and hypertrophic cardiomyopathy
Hematocrit \>2% below normal
Hemoglobin A1c \>8%
Use of insulin
ALT or AST \>2.5 times upper limit of normal
Glomerular filtration rate \< 60 mL/min
Hyponatremia. Note that, in order to be randomized, subjects must have Na ≥ 135 mEq/L.
Pregnancy or breastfeeding
Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
History of psychosis or active suicidal ideation
Major depressive disorder likely to require initiation or change in active treatment
Borderline personality disorder as assessed by the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD)
Current nicotine use, unless stable use for at least 12 weeks.
Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization
Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or subject safety

What this trial measures

  • Binge Frequency8 weeks

    Change in binge frequency as assessed by the Eating Disorder Examination clinical interview