A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
Purpose
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.
Condition
- Binge-eating Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Study staff and patients are blinded. The pharmacist is unblinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo Arm |
Solution without oxytocin |
|
|
Experimental TNX-1900 |
Solution with oxytocin |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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).