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

Yale University31 enrolled

Overview

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 .

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Binge-Eating Disorder Obesity

Interventions

Cognitive-Behavioral Therapy (CBT)BEHAVIORAL

CBT specialist treatment

NB Medication (on-going from acute treatment)DRUG

Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Yale School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Binge Eating Frequency (Continuous)

Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.

Time frame: 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

Time frame: Baseline and Post-treatment (4 months)

Secondary Outcomes

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).

Time frame: 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).

Time frame: 12-Month Follow-up

Data from ClinicalTrials.gov

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