Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Conditions
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Binge-Eating Disorder

Intervention / Treatment
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* Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NB Medication<br>Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination | Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination<br>* NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.<br>* Other names: Contrave;|
| Placebo Comparator: Placebo<br>Placebo will be inactive and taken daily in pill form. | Other: Placebo<br>* Placebo will be inactive and taken daily in pill form.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Binge Eating Frequency | 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. | Post-treatment (3 months) | 
| Percent BMI Change | 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. | Post-treatment (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating Frequency | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). | 12 months post-treatment | 
| Binge Eating Frequency | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). | 6 months post-treatment | 
| Body Mass Index | BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally. | 6 months post-treatment | 
| Body Mass Index | BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally. | 12 months post-treatment |