Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

Study Overview
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Brief Summary
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This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.

Official Title
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Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

Conditions
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Binge Eating Disorder

Intervention / Treatment
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* Drug: Naltrexone and bupropion combination
* Other: Pill 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 between 30 kg/m2 and 50 kg/m2 Not taking anti-depressant medications Read English proficiently enough to read study assessments Available for duration of treatment plus follow-up period Able to travel to study location (New Haven, CT) for monthly visits Agree to study procedures Exclusion Criteria: Medical status judged by study physician as contraindication History of seizures Past or current anorexia nervosa, bulimia nervosa Current medications that influence eating/weight Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Naltrexone/ Bupropion combination<br>50 mg naltrexone and 300 mg bupropion per day for 3 months | Drug: Naltrexone and bupropion combination<br> <br> |
| Placebo Comparator: Pill placebo<br>Daily placebo medication for 3 months | Other: Pill Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | Post-treatment (at 3 months) | 
| Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | 6 month follow-up (an average of 6 months following treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | BMI is calculated using measured height and weight. | Post-treatment (at 3 months) | 
| Body Mass Index (BMI) | BMI is calculated using measured height and weight. | 6 month follow-up (an average of 6 months following treatment) |