PMID- 37751990 OWN - NLM STAT- MEDLINE DCOM- 20231023 LR - 20240210 IS - 1930-739X (Electronic) IS - 1930-7381 (Print) IS - 1930-7381 (Linking) VI - 31 IP - 11 DP - 2023 Nov TI - Naltrexone/bupropion for binge-eating disorder: A randomized, double-blind, placebo-controlled trial. PG - 2762-2773 LID - 10.1002/oby.23898 [doi] AB - OBJECTIVE: Binge-eating disorder (BED) is a prevalent psychiatric disorder associated with obesity. Few evidence-based treatments exist for BED, particularly pharmacological options. This study tested the efficacy of naltrexone/bupropion for BED. METHODS: A randomized, double-blind, placebo-controlled, 12-week trial tested naltrexone/bupropion for BED with and without obesity. Eighty-nine patients (70.8% women, 69.7% White, mean age 45.7 y, mean BMI 35.1 kg/m(2) , 77.5% with BMI >/= 30 kg/m(2) ) were randomized to placebo (n = 46) or naltrexone/bupropion (n = 43), with randomization stratified by obesity status and gender; 92.1% completed post-treatment assessments. RESULTS: Mixed models of binge-eating frequency revealed significant reductions that did not differ significantly between naltrexone/bupropion and placebo. Logistic regression of binge-eating remission rates revealed that naltrexone/bupropion and placebo did not differ significantly. Obesity status did not predict, or moderate, binge-eating outcomes considered either continuously or categorically. Mixed models revealed that naltrexone/bupropion was associated with significantly greater percentage weight loss than placebo. Logistic regression revealed that naltrexone/bupropion had significantly higher rates of attaining >/=5% weight loss than placebo (27.9% vs. 6.5%). Obesity status did not predict or moderate weight-loss outcomes. CONCLUSIONS: Naltrexone/bupropion did not demonstrate effectiveness for reducing binge eating relative to placebo but showed effectiveness for weight reduction in patients with BED. Obesity status did not predict or moderate medication outcomes. CI - (c) 2023 The Obesity Society. FAU - Grilo, Carlos M AU - Grilo CM AUID- ORCID: 0000-0003-0245-3444 AD - Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA. FAU - Lydecker, Janet A AU - Lydecker JA AUID- ORCID: 0000-0001-6425-514X AD - Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA. FAU - Jastreboff, Ania M AU - Jastreboff AM AUID- ORCID: 0000-0003-1446-0991 AD - Department of Medicine (Endocrinology and Metabolism), Yale University School of Medicine, New Haven, Connecticut, USA. FAU - Pittman, Brian AU - Pittman B AD - Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA. FAU - McKee, Sherry A AU - McKee SA AD - Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA. LA - eng GR - K23 DK115893/DK/NIDDK NIH HHS/United States GR - R01 DK112771/DK/NIDDK NIH HHS/United States GR - UL1 TR001863/TR/NCATS NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural DEP - 20230926 PL - United States TA - Obesity (Silver Spring) JT - Obesity (Silver Spring, Md.) JID - 101264860 RN - 01ZG3TPX31 (Bupropion) RN - 5S6W795CQM (Naltrexone) SB - IM MH - Humans MH - Female MH - Middle Aged MH - Male MH - Bupropion/therapeutic use MH - Naltrexone/therapeutic use MH - *Binge-Eating Disorder/complications MH - Obesity/therapy MH - *Bulimia/complications MH - Weight Loss MH - Double-Blind Method MH - Treatment Outcome PMC - PMC10600891 MID - NIHMS1938836 COIS- Potential Conflicts of interest: The authors declare no conflicts of interest relative to this study. Dr. Grilo reports broader interests, which did not influence this research, including Honoraria for lectures, and Royalties from Guilford Press and Taylor & Francis Publishers for academic books. Dr. Jastreboff reports broader interests, which did not influence this study, including serving on Scientific Advisory Boards for to Amgen, AstraZeneca, BioHaven Pharmaceuticals, Boehringer Ingelheim, Eli Lilly and Company, Intellihealth, Novo Nordisk, , Pfizer, Rhythm Pharmaceuticals, Scholar Rock, Structure Therapeutics, Terns Pharmaceuticals, Weight Watchers International, and Zealand Pharma A/S. EDAT- 2023/09/27 00:42 MHDA- 2023/10/23 01:18 PMCR- 2024/11/01 CRDT- 2023/09/26 21:22 PHST- 2023/08/01 00:00 [revised] PHST- 2023/05/25 00:00 [received] PHST- 2023/08/04 00:00 [accepted] PHST- 2024/11/01 00:00 [pmc-release] PHST- 2023/10/23 01:18 [medline] PHST- 2023/09/27 00:42 [pubmed] PHST- 2023/09/26 21:22 [entrez] AID - 10.1002/oby.23898 [doi] PST - ppublish SO - Obesity (Silver Spring). 2023 Nov;31(11):2762-2773. doi: 10.1002/oby.23898. Epub 2023 Sep 26.