This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.
Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
Placebo will be inactive and taken daily in pill form.
Yale School of Medicine
New Haven, Connecticut, United States
Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."
Time frame: Post-treatment (3 months)
Percent BMI Change
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at posttreatment\] - \[BMI at baseline\])/\[BMI at baseline\]. Negative values indicate loss.
Time frame: Post-treatment (3 months)
Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.
Time frame: 6 months post-treatment
Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.
Time frame: 12 months post-treatment
Body Mass Index
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at 6 month followup\] - \[BMI at posttreatment\])/\[BMI at posttreatment\]. Negative values indicate loss.
Time frame: 6 months post-treatment
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Body Mass Index
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at 12 month followup\] - \[BMI at posttreatment\])/\[BMI at posttreatment\]. Negative values indicate loss.
Time frame: 12 months post-treatment