Intranasal oxytocin treatment for adults with binge-eating disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.