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).
Eligibility Criteria
Age Range: 18 years to 70 years
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
Interventions
DRUG
TNX-1900 (Tonix Pharmaceuticals)
DRUG
Placebo