Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study

Abstract

Purpose: Binge-eating disorder (BED), the most prevalent eating disorder, is associated strongly with obesity and functional impairments. Few evidence-based treatments for BED exist; a pharmacotherapy effective in reducing both binge eating and weight needs to be identified. This placebo-controlled double-blind pilot RCT evaluated the acute effects of naltrexone + bupropion (NB) on BED with obesity and examined the longer-term effects through 6-month follow-up after the discontinuation of medication.

Methods: Twenty-two adult patients with BED were randomized to receive 12 weeks of double-blind treatment with fixed-dose NB (naltrexone + bupropion XL 50/300 mg) or placebo. Independent (blinded) researcher-clinicians evaluated patients at major outcome time points (baseline, posttreatment, and 6-month follow-up after the treatment period); patients were also evaluated for the tracking of course/tolerability throughout treatments and at 3-month follow-up. Primary outcomes were changes from baseline in binge-eating frequency and percentage weight. Secondary outcomes were changes in eating-disorder psychopathology and depression.

Findings: A total of 22 patients were enrolled (86.4% women; mean age, 50.4 years), with 77.3% of patients completing treatments; completion rates (NB, 83.3%; placebo, 70.0%) and adverse events did not differ significantly between NB and placebo. Analyses revealed significant reductions from baseline in binge-eating, eating-disorder psychopathology, depression, and weight during treatment, but these changes with NB did not differ significantly from those with placebo. The percentage of patients who attained 3% weight loss was significantly greater with NB than with placebo (45.5% vs 0%); weight-loss and binge-eating reductions were significantly correlated in the group that received NB. At 6-month follow-up, outcomes remained improved relative to baseline, with no significant differences between NB and placebo.

Implications: The findings from this pilot RCT suggest that NB was well-tolerated in these patients with BED and comorbid obesity. Most outcomes were not statistically different between NB and placebo. A larger-scale, adequately powered RCT is needed for determining the efficacy of NB in the treatment of BED. ClinicalTrials.gov identifier: NCT02317744.

Keywords: binge-eating disorder; bupropion; eating disorders; naltrexone; obesity; pharmacotherapy.

Conflict of interest statement

CONFLICTS OF INTEREST

C.M. Grilo has received consultant’s fees from Sunovion and Weight Watchers; honoraria for lectures, Continuing Medical Education activities, and presentations at scientific conferences; and royalties from Guilford Press and Taylor & Francis. R. Gueorguieva has received royalties from CRC Press, and consultant’s fees from Cohen Veterans Bioscience. The authors have indicated that they have no conflicts of interest with regard to the content of this article.

Copyright © 2020 Elsevier Inc. All rights reserved.

Figures

Figure 1.

CONSORT diagram of patient flow through eligibility determination, study treatment, and follow-up assessment phases. BED = binge-eating disorder; BMI = body mass index; BN = bulimia nervosa; NB = naltrexone/bupropion.

Figure 2.

A. Effects of naltrexone/bupropion (NB) treatment on binge-eating frequency (A) and percentage weight loss (B) at posttreatment and 6-month follow-up (FU) (after treatment cessation). Binge-eating frequency was measured by the Eating Disorder Examination; differences were not statistically significant. Percentage weight loss was calculated as the difference between time point weight and baseline weight, divided by baseline weight. Negative values reflect weight loss. Weight loss was significantly greater with NB than with placebo at month 2 but not at other time points. Group and time did not have main effects, although the group-by time-interaction showed a nonsignificant trend (P = 0.085).