Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

Study Overview
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Brief Summary
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This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

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 obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

Official Title
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Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Conditions
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Obesity, Binge-Eating Disorder

Intervention / Treatment
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* Drug: NB medication (Naltrexone Bupropion combination)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in acute treatment for binge-eating disorder and obesity; Had a positive response to acute treatment; 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; and Able to travel to study location (New Haven, CT) for monthly 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.

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>Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. | Drug: NB medication (Naltrexone Bupropion combination)<br>* NB medication<br>* Other names: Contrave;|
| Placebo Comparator: Placebo<br>Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. | Other: Placebo<br>* Placebo<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 will be defined continuously (analyzed dimensionally). | Post-treatment (4 months) | 
| Change in Body Mass Index | BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss. | baseline and Post-treatment (4 months) | 

Secondary 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 will be defined continuously (analyzed dimensionally). | 6-Month Follow-up | 
| Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). | 12-Month Follow-up | 
| Body Mass Index | BMI is calculated using measured height and weight (e.g., percent loss) | 6-Month Follow-up | 
| Body Mass Index | BMI is calculated using measured height and weight (e.g., percent loss) | 12-Month Follow-up |