Recruiting
Phase 2

Oxytocin

Sponsor:

Massachusetts General Hospital

Code:

NCT05664516

Conditions

Binge-eating Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

TNX-1900 (Tonix Pharmaceuticals)

Placebo

Study Details

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.

Conditions

Binge-eating Disorder

Study ID

NCT05664516

Start date

Mar 7, 2023

Status verified date

Jul, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Arm

Solution without oxytocin

experimental: TNX-1900

Solution with oxytocin

Interventions

TNX-1900 (Tonix Pharmaceuticals)

oxytocin nasal spray

Placebo

Nasal solution without oxytocin

Primary outcome measure

  • Binge Frequency [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Lauren Shabazian, NP

617-726-0047lshabazian@mgh.harvard.edu

Frances Ross

617-726-0047fross2@mgh.harvard.edu

Locations

Neuroendocrine Unit Research Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Lauren Shabazian, MSN

627-726-0047lshabazian@mgh.harvard.edu

Frances Ross

627-726-0047fross2@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 14, 2026

Last verified

Jul, 2026

Keywords

  • Binge
  • Binge-eating disorder
  • Oxytocin
  • Over-eating
  • Impulse Control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-14.