A Double‐Blind Randomized Placebo‐Controlled Trial of Oral Naltrexone for Heavy‐Drinking Smokers Seeking Smoking Cessation Treatment. (7th May 2017)

• Record Type: Journal Article
• Authors: Kahler, Christopher W.; Cioe, Patricia A.; Tzilos, Golfo K.; Spillane, Nichea S.; Leggio, Lorenzo; Ramsey, Susan E.; Brown, Richard A.; O'Malley, Stephanie S.
• Is Part Of: Alcoholism. Volume 41:Number 6(2017)
• Page Start: 1201
• Page End: 1211
• Publication Date: 2017-05-07
• Subjects: Naltrexone -- Heavy Drinking -- Alcohol Dependence -- Smoking Cessation; Alcoholism -- Periodicals; Alcoholism -- Periodicals; Alcoolisme; Electronic journals; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.861005
• DOI: 10.1111/acer.13396
• Languages: English
• ISSNs: 0145-6008

Abstract

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. Abstract : This randomized placebo‐controlled trial tested the efficacy of daily 50 mg oral naltrexone for reducing drinking in 150 heavy drinkers receiving smoking cessation treatment that also included counseling on alcohol reduction. Although participants reduced drinking substantially during follow‐up, naltrexone compared to placebo did not yield significantly greater reductions in percent heavy drinking days (effect size d = −0.04, 95% CI [−0.30, 0.22], p = 0.76) or greater smoking abstinence (odds ratio = 0.93, 95% CI [0.46, 1.86], p = 0.83).