Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment

Study Overview
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Brief Summary
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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.

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 obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity combination medication), alone and in combination, for the treatment of BED in patients with obesity. The acute treatment stage stage RCT will provide new findings regarding the effectiveness of NB medication and whether this specific combination of BWL and NB medication is effective for patients with obesity and BED. N=160 patients with BED and obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study will produce important new information about the relative efficacy of BWL and this recently FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with obesity.

Official Title
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Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Conditions
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Binge-eating Disorder, Obesity

Intervention / Treatment
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* Drug: NB medication (Naltrexone Bupropion combination)
* Behavioral: Behavioral Weight Loss (BWL) counseling
* 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 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.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BWL + NB medication<br>Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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;Behavioral: Behavioral Weight Loss (BWL) counseling<br>* BWL counseling<br>|
| Experimental: BWL + Placebo<br>Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form. | Behavioral: Behavioral Weight Loss (BWL) counseling<br>* BWL counseling<br>Other: Placebo<br>* Placebo<br>|
| 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) | 
| Body Mass Index (Percent Weight Loss) | BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline. | Post-treatment (4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Meeting Response Criteria | Binge eating frequency will be assessed by interview and self-report. Frequency is defined categorically (response to treatment or non-response to treatment). Response to treatment is defined as a 65% reduction in binge eating frequency in past month, compared to baseline. | Post-treatment (4 months) |