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

Study Overview
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Brief Summary
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This study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .

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 (specialist treatment) RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).

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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* Behavioral: Cognitive-Behavioral Therapy (CBT)
* Drug: NB Medication (on-going from acute treatment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in acute treatment for binge-eating disorder and obesity; Did not have 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 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Therapy (CBT)<br>CBT is a specialist focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. | Behavioral: Cognitive-Behavioral Therapy (CBT)<br>* CBT specialist treatment<br>Drug: NB Medication (on-going from acute treatment)<br>* Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)<br>* Other names: Contrave;|
| Active Comparator: Naltrexone/bupropion (NB) (on-going from acute stage)<br>Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. | Drug: NB Medication (on-going from acute treatment)<br>* Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)<br>* Other names: Contrave;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating Frequency (Continuous) | Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously. | Post-treatment (4 months) | 
| Change in Body Mass Index at 4 Months Post-Treatment From Baseline | BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline | 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 |