PMID- 33218742 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20220102 IS - 1879-114X (Electronic) IS - 0149-2918 (Print) IS - 0149-2918 (Linking) VI - 43 IP - 1 DP - 2021 Jan TI - Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. PG - 112-122.e1 LID - S0149-2918(20)30478-1 [pii] LID - 10.1016/j.clinthera.2020.10.010 [doi] AB - 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. CI - Copyright (c) 2020 Elsevier Inc. All rights reserved. FAU - Grilo, Carlos M AU - Grilo CM AD - Department of Psychiatry, School of Medicine, Yale University, New Haven, CT, USA; Department of Psychology, Yale University, New Haven, CT, USA. Electronic address: carlos.grilo@yale.edu. FAU - Lydecker, Janet A AU - Lydecker JA AD - Department of Psychiatry, School of Medicine, Yale University, New Haven, CT, USA. FAU - Morgan, Peter T AU - Morgan PT AD - Department of Psychiatry, School of Medicine, Yale University, New Haven, CT, USA; Department of Psychiatry, Lawrence and Memorial Hospital, New London, CT, USA. FAU - Gueorguieva, Ralitza AU - Gueorguieva R AD - Department of Psychiatry, School of Medicine, Yale University, New Haven, CT, USA; Department of Biostatistics, School of Public Health, Yale University, New Haven, CT, USA. LA - eng SI - ClinicalTrials.gov/NCT02317744 GR - UL1 TR001863/TR/NCATS NIH HHS/United States GR - R01 DK112771/DK/NIDDK NIH HHS/United States GR - R01 DK049587/DK/NIDDK NIH HHS/United States GR - K24 DK070052/DK/NIDDK NIH HHS/United States GR - K23 DK115893/DK/NIDDK NIH HHS/United States GR - R01 DK114075/DK/NIDDK NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural DEP - 20201118 PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 RN - 0 (Anti-Obesity Agents) RN - 0 (Drug Combinations) RN - 0 (Naltrexone-Bupropion combination) RN - 01ZG3TPX31 (Bupropion) RN - 5S6W795CQM (Naltrexone) SB - IM MH - Adult MH - Anti-Obesity Agents/*therapeutic use MH - Binge-Eating Disorder/*drug therapy MH - Body Weight/drug effects MH - Bupropion/*therapeutic use MH - Double-Blind Method MH - Drug Combinations MH - Female MH - Humans MH - Male MH - Middle Aged MH - Naltrexone/*therapeutic use MH - Obesity/*drug therapy MH - Pilot Projects MH - Treatment Outcome PMC - PMC7902424 MID - NIHMS1642823 OTO - NOTNLM OT - binge-eating disorder OT - bupropion OT - eating disorders OT - naltrexone OT - obesity OT - pharmacotherapy COIS- 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. EDAT- 2020/11/22 06:00 MHDA- 2021/05/15 06:00 PMCR- 2022/01/01 CRDT- 2020/11/21 05:28 PHST- 2020/10/19 00:00 [received] PHST- 2020/10/27 00:00 [revised] PHST- 2020/10/28 00:00 [accepted] PHST- 2020/11/22 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/11/21 05:28 [entrez] PHST- 2022/01/01 00:00 [pmc-release] AID - S0149-2918(20)30478-1 [pii] AID - 10.1016/j.clinthera.2020.10.010 [doi] PST - ppublish SO - Clin Ther. 2021 Jan;43(1):112-122.e1. doi: 10.1016/j.clinthera.2020.10.010. Epub 2020 Nov 18.