title: A Double-Blind Randomized Placebo-Controlled Trial of Oral Naltrexone for Heavy-Drinking Smokers Seeking Smoking Cessation Treatment.
abstract: BACKGROUND
  Post hoc analyses of 2 randomized controlled trials suggest naltrexone may reduce alcohol use and improve smoking cessation outcomes among heavy drinkers receiving smoking cessation treatment. However, no studies have been conducted specifically to examine naltrexone for this purpose or to test whether naltrexone has benefit when added to smoking cessation counseling that explicitly addresses heavy drinking.
  
  
  METHODS
  We recruited heavy-drinking smokers from the community and randomized them to receive 10 weeks of either (i) 50 mg naltrexone (n = 75) or (ii) placebo (n = 75) daily. Participants received 6 weeks of transdermal nicotine patch and 6 sessions of counseling that addressed both heavy drinking and smoking. Participants were followed for 26 weeks after their target quit smoking date.
  
  
  RESULTS
  Across medication conditions, there were substantial reductions at follow-up in percent heavy drinking days (primary outcome) and average drinks per week (secondary outcome). However, participants receiving naltrexone did not differ significantly from those receiving placebo on percent heavy drinking days (effect size d = -0.04, 95% CI [-0.30, 0.22], p = 0.76) or average drinks per week (d = -0.09, 95% CI [-0.35, 0.18], p = 0.54) during follow-up. Naltrexone compared to placebo was not associated with a significant increase in smoking abstinence rates during follow-up, odds ratio = 0.93, 95% CI [0.46, 1.86], p = 0.83. The effect of naltrexone on these outcomes was not significantly moderated by current alcohol dependence or gender.
  
  
  CONCLUSIONS
  Results indicate that heavy-drinking smokers, including those with current alcohol dependence, can make substantial reductions in drinking in the context of smoking cessation treatment. However, this study provided no evidence that naltrexone is efficacious for enhancing reductions in drinking or improving smoking cessation in this population. Limitations of this study included lower-than-desired sample size and modest adherence to study medication.
authors.affiliation: Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.
authors.forename: Christopher W
authors.identifier: http://orcid.org/0000-0002-6248-4149
authors.initials: CW
authors.lastname: Kahler
authors.affiliation: Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Cioe
authors.affiliation: Department of Family Medicine, University of Michigan, Ann Arbor, Michigan.
authors.forename: Golfo K
authors.initials: GK
authors.lastname: Tzilos
authors.affiliation: Department of Psychology, University of Rhode Island, South Kingston, Rhode Island.
authors.forename: Nichea S
authors.initials: NS
authors.lastname: Spillane
authors.affiliation: Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.|Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, Bethesda, Maryland.
authors.forename: Lorenzo
authors.identifier: http://orcid.org/0000-0001-7284-8754
authors.initials: L
authors.lastname: Leggio
authors.affiliation: Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, Rhode Island.|Department of Medicine, The Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, Rhode Island.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Ramsey
authors.affiliation: University of Texas at Austin, Austin, Texas.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Brown
authors.affiliation: Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.
authors.forename: Stephanie S
authors.initials: SS
authors.lastname: O'Malley
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage*; D009292:Narcotic Antagonists / Q000008:administration & dosage; D010342:Patient Acceptance of Health Care / Q000523:psychology; D012907:Smoking / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D016540:Smoking Cessation / Q000379:methods / Q000523:psychology*; D061485:Tobacco Use Cessation Devices; D016896:Treatment Outcome
chemical_list: D009292:Narcotic Antagonists; D009271:Naltrexone
keywords: Alcohol Dependence; Heavy Drinking; Naltrexone; Smoking Cessation