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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Binge-eating Disorder
• Intervention / Treatment: Drug: Placebo; Drug: TNX-1900 (Tonix Pharmaceuticals)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lauren Shabazian, NP; Phone Number: 617-726-0047; Email: lshabazian@mgh.harvard.edu
• Study Contact Backup: Name: Jordan Hillard; Phone Number: 617-726-0047; Email: jhillard1@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Neuroendocrine Unit Research Center
      • Contact: Lauren Shabazian, MSN; Email: lshabazian@mgh.harvard.edu
      • Contact: Jordan Hillard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm; Solution without oxytocin	Drug: Placebo; Nasal solution without oxytocin
Experimental: TNX-1900; Solution with oxytocin	Drug: TNX-1900 (Tonix Pharmaceuticals); oxytocin nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge Frequency	Change in binge frequency as assessed by the Eating Disorder Examination clinical interview	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impulse control	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	8 weeks
Reward sensitivity	Predictive value of 4-week change in reward sensitivity per the Temporal Experience of Pleasure Scale (TEPS) Anticipatory Experience of Pleasure subscale score for 8-week change in binge episodes. Higher scores=greater anticipatory pleasuure/less anhedonia. Minimum/Maximum: 10-60	8 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Elizabeth A Lawson, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Oxytocin; Impulse Control; Binge; Binge-eating disorder; Over-eating
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Binge-Eating Disorder; Hyperphagia
• Other Study ID Numbers: 2022P002727

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No