1. In this randomized controlled trial, combined treatment with varenicline and nicotine patch produced higher smoking cessation rates versus nicotine patch with placebo over a 12-week period for 122 participants who concurrently consumed alcohol in excess.
2. There was no significant difference in reduction of alcohol consumption in the varenicline group versus placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Concurrent use of both tobacco and alcohol results in higher rates of cancer, pulmonary and cardiovascular disease, and an overall increase in mortality risk. Although combined treatment with varenicline and nicotine patches are known to be an a highly effective pharmacotherapy approved for smoking cessation, the treatment’s effects have not been examined among smokers who drink heavily. This randomized controlled trial investigated the combined treatment of varenicline and nicotine patch on smoking cessation rates over 9-12 weeks in smokers who drank heavily (defined as an Alcohol Use Disorders Identification Test score greater or equal to 8). The primary outcome for this study was self-reported continuous cigarette abstinence over 12 weeks. Secondary outcomes included the frequency of weekly drinking, and heavy drinking during the study period. Among the 122 participants (mean age, 44.0 [12.4] years; 61 men [54.9%]), the varenicline group consisted of 61 participants randomly assigned to receive a combined treatment (varenicline and nicotine patch), and the placebo group consisted of 61 participants randomly assigned to receive a placebo and nicotine patch. Smoking cessation rates were higher for participants in the varenicline group receiving combined treatment in comparison to the placebo group. Frequency of heavy drinking and any alcohol drinking were decreased by 54% over 12 weeks amongst both groups, without significant difference in decrease in either arm. These results suggest that there is potential for smokers who drink heavily to be enrolled and retain in a smoking cessation treatment program. A limitation to this study is the smaller sample size, which precludes the analyses of moderators of varenicline’s effects, such as sex and race.
In-Depth [randomized controlled trial]: This study included 122 participants that were randomized to receive either varenicline and nicotine patch (n=61), or placebo (n=61) and investigated smoking cessation rates in smokers who drink heavily. Smoking cessation rates were higher in the varenicline group in comparison to the placebo group during the 9 to 12 weeks (OR, 2.20; 95% CI, 1.01-4.80; P=.047). The combination treatment resulted in a quit rate of 44.3%. A lower likelihood of relapse for patients with continuous cigarette use was confirmed in those in the varenicline group (HR, 0.62; 95% CI, 0.40-0.96, P=.03). Participants were enrolled in the study independent of their desire to change their alcohol consumption patterns, however both groups saw a decrease in weekly drinking days by 25% (P = .003) and weekly heavy drinking days decreased by 54% (P = .004); difference in this outcome was nonsignificant (P = .81). Additionally, participants in the combined treatment group experienced significantly more frequent nausea (34 participants; P = .003). Adverse events were rated as mild or moderate among both groups.
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