Intranasal oxytocin treatment for adults with binge-eating disorder
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder
This trial tests whether 8 weeks of intranasal oxytocin can reduce binge-eating episodes in adults with binge-eating disorder.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05664516 on ClinicalTrials.gov |
What this trial studies
Adults with binge-eating disorder will be randomized 1:1 to receive intranasal oxytocin (TNX-1900) or placebo for 8 weeks in a double-blind design, with at least 60 participants planned. Clinical visits occur at baseline, weeks 2, 4, 8, and a follow-up at week 16 and include medical history, physical exams, labs, ECGs, and standardized measures of eating behavior. The study will monitor safety and tolerability while tracking changes in binge frequency and related symptoms. Investigators will also explore whether early changes in homeostatic appetite, reward sensitivity, or impulse control at week 4 predict treatment success at week 8.
Who should consider this trial
Good fit: Adults aged 18–70 with binge-eating disorder (or OSFED-BED/BN with bingeing as specified), BMI ≥ 18.5, who are not currently using medications for binge eating and meet the study's screening criteria are ideal candidates.
Not a fit: Patients with active substance use disorder within the past 6 months, recent unstable medication changes, current medications for binge eating, BMI < 18.5, or who cannot commit to in-person visits are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, this could offer a new medication option that reduces binge frequency and improves impulse control and eating behavior with a tolerable safety profile.
How similar studies have performed: Previous small studies of intranasal oxytocin in eating and impulse-control contexts have shown mixed or modest signals, so the approach is promising but not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Neuroendocrine Unit Research Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth A Lawson, MD — Massachusetts General Hospital
- Study coordinator: Lauren Shabazian, NP
- Email: lshabazian@mgh.harvard.edu
- Phone: 617-726-0047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.