Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Overview
- Phase
- Phase 2
- Intervention
- Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
- Conditions
- Binge-Eating Disorder
- Sponsor
- Yale University
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Percent BMI Change
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.
Detailed Description
Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.
Investigators
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 in the obesity (BMI \>30 and \<50) or non-obesity (BMI \>21.5 and \<29.9) range;
- •Available for the duration of the treatment and follow-up (15 months);
- •Read, comprehend, and write English at a sufficient level to complete study-related materials.
Exclusion Criteria
- •Currently taking opioid pain medications or drugs; or positive drug screen for opiates
- •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 or bulimia nervosa;
- •Pregnant or breastfeeding;
- •Medical status judged by study physician as contraindication.
Arms & Interventions
NB Medication
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Intervention: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Placebo
Placebo will be inactive and taken daily in pill form.
Intervention: Placebo
Outcomes
Primary Outcomes
Percent BMI Change
Time Frame: Post-treatment (3 months)
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at posttreatment\] - \[BMI at baseline\])/\[BMI at baseline\]. Negative values indicate loss.
Change in Binge Eating Frequency
Time Frame: Post-treatment (3 months)
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."
Secondary Outcomes
- Body Mass Index(12 months post-treatment)
- Change in Binge Eating Frequency(12 months post-treatment)