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A Double‐Blind Randomized Placebo‐Controlled Trial of Oral Naltrexone for Heavy‐Drinking Smokers Seeking Smoking Cessation Treatment
Author(s) -
Kahler Christopher W.,
Cioe Patricia A.,
Tzilos Golfo K.,
Spillane Nichea S.,
Leggio Lorenzo,
Ramsey Susan E.,
Brown Richard A.,
O'Malley Stephanie S.
Publication year - 2017
Publication title -
alcoholism: clinical and experimental research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.267
H-Index - 153
eISSN - 1530-0277
pISSN - 0145-6008
DOI - 10.1111/acer.13396
Subject(s) - naltrexone , medicine , placebo , smoking cessation , abstinence , randomized controlled trial , odds ratio , craving , heavy drinking , psychiatry , poison control , addiction , injury prevention , environmental health , opioid , alternative medicine , receptor , pathology
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.