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

NCT ID: NCT05664516

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-07
• Study Completion Date: 2026-12-31

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).

Conditions

Binge-eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Arm

Solution without oxytocin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Nasal solution without oxytocin

TNX-1900

Solution with oxytocin

Group Type: EXPERIMENTAL

TNX-1900 (Tonix Pharmaceuticals)

Intervention Type: DRUG

oxytocin nasal spray

Interventions

TNX-1900 (Tonix Pharmaceuticals)

oxytocin nasal spray

Intervention Type: DRUG

Placebo

Nasal solution without oxytocin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Austen Lawson

Director, Interdisciplinary Oxytocin Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth A Lawson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Neuroendocrine Unit Research Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Shabazian, NP

Role: CONTACT

lshabazian@mgh.harvard.edu

617-726-0047

Jordan Hillard

Role: CONTACT

jhillard1@mgh.harvard.edu

617-726-0047

Facility Contacts

Lauren Shabazian, MSN

Role: primary

lshabazian@mgh.harvard.edu

Jordan Hillard

Role: backup

Other Identifiers

2022P002727

Identifier Type: -

Identifier Source: org_study_id