Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
- Study HIC#:2000021769
- Last Updated:01/01/0001
Brief Summary:
This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.
- Age18 years - 70 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Janet Lydecker
- Phone Number: 1-203-785-7210
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
To conduct a double-blind, placebo-controlled parallel group study to evaluate the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), stratified by obesity status (n=50 per cell, n=200 total)
Eligibility Criteria
Inclusion Criteria:
- Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
- BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;
- Available for the duration of the treatment and follow-up (20 months);
- Read, comprehend, and write English at a sufficient level to complete study-related materials;
- Able to travel to study location (New Haven, CT) for weekly visits.
Exclusion Criteria:
- Currently taking anti-depressant medications;
- Currently taking opioid pain medications or drugs;
- Currently taking medications that influence eating/weight;
- History of seizures;
- Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
- Past or current anorexia nervosa, bulimia nervosa;
- Pregnant or breastfeeding;
- Medical status judged by study physician as contraindication.
