Kahler Christopher W, Cioe Patricia A, Tzilos Golfo K, Spillane Nichea S, Leggio Lorenzo, Ramsey Susan E, Brown Richard A, O'Malley Stephanie S
Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.
Department of Family Medicine, University of Michigan, Ann Arbor, Michigan.
Alcohol Clin Exp Res. 2017 Jun;41(6):1201-1211. doi: 10.1111/acer.13396. Epub 2017 May 7.
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.
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.
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.
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.
两项随机对照试验的事后分析表明，纳曲酮可能会减少饮酒量，并改善接受戒烟治疗的重度饮酒者的戒烟效果。然而，尚未专门针对此目的进行研究，以检验纳曲酮在此情况下的效果，或测试在明确针对重度饮酒问题的戒烟咨询中加入纳曲酮是否有益。
我们从社区招募了重度饮酒吸烟者，并将他们随机分为两组，一组每天服用50毫克纳曲酮（n = 75），另一组每天服用安慰剂（n = 75），为期10周。参与者接受6周的经皮尼古丁贴片治疗，并接受6次针对重度饮酒和吸烟问题的咨询。在目标戒烟日期后，对参与者进行26周的随访。
在所有药物治疗条件下，随访时重度饮酒天数百分比（主要结局）和每周平均饮酒量（次要结局）均有大幅下降。然而，在随访期间，接受纳曲酮治疗的参与者与接受安慰剂治疗的参与者在重度饮酒天数百分比（效应量d = -0.04，95%置信区间[-0.30, 0.22]，p = 0.76）或每周平均饮酒量（d = -0.09，95%置信区间[-0.35, 0.18]，p = 0.54）方面没有显著差异。与安慰剂相比，纳曲酮在随访期间与戒烟率的显著提高无关，优势比 = 0.93，95%置信区间[0.46, 1.86]，p = 0.83。纳曲酮对这些结局的影响并未因当前酒精依赖或性别而有显著差异。
结果表明，包括当前存在酒精依赖的重度饮酒吸烟者，在戒烟治疗过程中饮酒量可大幅减少。然而，本研究没有提供证据表明纳曲酮对增强该人群的饮酒量减少或改善戒烟有效。本研究的局限性包括样本量低于预期以及对研究药物的依从性一般。
