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

Phase 2

Recruiting

• Conditions: Binge-eating Disorder
• Interventions: Drug: Placebo; Drug: TNX-1900 (Tonix Pharmaceuticals)

• Registration Number: NCT05664516
• Lead Sponsor: Massachusetts General Hospital

Brief 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).

Study Timeline

• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-23
• Study Start: 2023-03-07
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-22
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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 Criteria

• 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; epilepsy; untreated thyroid disease
• History of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	Solution without oxytocin
TNX-1900	TNX-1900 (Tonix Pharmaceuticals)	Solution with oxytocin

Primary Outcome Measures

Name	Time	Method
Binge Frequency	8 weeks	Change in binge frequency as assessed by the Eating Disorder Examination clinical interview

Secondary Outcome Measures

Name	Time	Method
Reward sensitivity	8 weeks	Predictive value of 4 week change in reward sensitivity per TEPS Anticipatory Experience of Pleasure Scale score for 8-week change in binge episodes.
Impulse control	8 weeks	Predictive value of 4 week change in impulse control per Stop-Signal Reaction time in a Stop-Signal Task for 8 week change in binge frequency

Trial Locations

Locations (1)

Neuroendocrine Unit Research Center; 🇺🇸 Boston, Massachusetts, United States