Ray Lara A, Green ReJoyce, Enders Craig, Leventhal Adam M, Grodin Erica N, Li Gang, Lim Aaron, Hartwell Emily, Venegas Alex, Meredith Lindsay, Nieto Steven J, Shoptaw Steven, Ho Diana, Miotto Karen
Department of Psychology (Ray, Green, Enders, Grodin, Lim, Hartwell, Venegas, Meredith, Nieto, Ho), Department of Psychiatry and Biobehavioral Sciences (Ray, Miotto), Department of Biostatistics (Li), and Department of Family Medicine (Shoptaw), University of California, Los Angeles; Department of Preventive Medicine, University of Southern California, Los Angeles (Leventhal).
Am J Psychiatry. 2021 Sep 1;178(9):818-828. doi: 10.1176/appi.ajp.2020.20070993. Epub 2021 Jun 3.
Pharmacological treatments that can concomitantly address cigarette smoking and heavy drinking stand to improve health care delivery for these highly prevalent co-occurring conditions. This superiority trial compared the combination of varenicline and naltrexone against varenicline alone for smoking cessation and drinking reduction among heavy-drinking smokers.
This was a phase 2 randomized double-blind clinical trial. Participants (N=165) who were daily smokers and drank heavily received either 2 mg/day of varenicline plus 50 mg/day of naltrexone or 2 mg/day of varenicline plus matched placebo pills for 12 weeks. Primary outcomes were 7-day point prevalence of nicotine abstinence (bioverified by a breath CO reading ≤5 ppm) at the 26-week follow-up and number of drinks per drinking day during the 12-week treatment phase.
Smoking abstinence at week 26 was significantly higher in the varenicline plus placebo condition than in the varenicline plus naltrexone condition (N=37 [45.1%] compared with N=22 [26.5%]). For drinks per drinking day, there was a medication effect favoring the combination of varenicline and naltrexone over varenicline alone across the 12-week treatment phase, although it did not meet the significance threshold.
These findings suggest that smoking cessation and drinking reduction can be concomitantly targeted with pharmacotherapy and that while varenicline alone may be sufficient as a smoking cessation aid in heavy-drinking smokers, the combination of varenicline and naltrexone may confer benefits with regard to drinking outcomes, particularly during the 12-week period of active medication treatment.
能够同时解决吸烟和酗酒问题的药物治疗，有望改善针对这些高度普遍的共病情况的医疗服务。这项优效性试验比较了伐尼克兰与纳曲酮联合用药和单独使用伐尼克兰在重度饮酒吸烟者戒烟和减少饮酒方面的效果。
这是一项2期随机双盲临床试验。每日吸烟且酗酒的参与者（N = 165）接受2毫克/天的伐尼克兰加50毫克/天的纳曲酮或2毫克/天的伐尼克兰加匹配的安慰剂药丸，为期12周。主要结局是在26周随访时尼古丁戒断的7天点患病率（通过呼气一氧化碳读数≤5 ppm进行生物验证）以及12周治疗阶段中每个饮酒日的饮酒量。
在26周时，伐尼克兰加安慰剂组的戒烟率显著高于伐尼克兰加纳曲酮组（分别为N = 37 [45.1%] 和N = 22 [26.5%]）。对于每个饮酒日的饮酒量，在12周治疗阶段，有药物效应表明伐尼克兰与纳曲酮联合用药优于单独使用伐尼克兰，尽管未达到显著性阈值。
这些发现表明，药物治疗可以同时针对戒烟和减少饮酒，虽然单独使用伐尼克兰可能足以帮助重度饮酒吸烟者戒烟，但伐尼克兰与纳曲酮联合使用可能在饮酒结果方面带来益处，特别是在12周的积极药物治疗期间。
