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

Yale University22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Binge Eating Disorder

Interventions

Naltrexone and bupropion combinationDRUG

Pill PlaceboOTHER

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 6 month follow-up (an average of 6 months following treatment)

Secondary Outcomes

Body Mass Index (BMI)

BMI is calculated using measured height and weight.

Time frame: Post-treatment (at 3 months)

Body Mass Index (BMI)

BMI is calculated using measured height and weight.

Time frame: 6 month follow-up (an average of 6 months following treatment)

Data from ClinicalTrials.gov

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