@article{TEXTUAL,
      recid = {11216},
      author = {King, Andrea and Vena, Ashley and de Wit, Harriet and  Grant, Jon E. and Cao, Dingcai},
      title = {Effect of Combination Treatment with Varenicline and  Nicotine Patch on Smoking Cessation among Smokers Who Drink  Heavily: A Randomized Clinical Trial},
      journal = {JAMA Network Open},
      address = {2022-03-04},
      number = {TEXTUAL},
      abstract = {&lt;p&gt;Importance: The concurrent use of both tobacco and  alcohol causes substantial disease and early mortality, and  smokers who drink heavily tend to be less successful in  smoking cessation than smokers who do not. Although  varenicline combined with nicotine replacement therapy for  smoking cessation has been examined among smokers who do  not drink heavily, this combination treatment has not yet  been examined among smokers who drink heavily.&lt;/p&gt;  &lt;p&gt;Objective: To determine whether combined treatment with  varenicline tartrate and nicotine patch improves continuous  abstinence from cigarette smoking among smokers who drink  heavily.&lt;/p&gt; &lt;p&gt;Design, Setting, and Participants: This  double-blind, placebo-controlled, superiority randomized  clinical trial evaluated combined treatment with  varenicline and nicotine patch compared with placebo and  nicotine patch for smoking cessation (primary outcome) and  drinking behavior (secondary outcome) among smokers who  drink heavily. The clinical trial was conducted at 2  outpatient sites in Chicago, Illinois, with enrollment from  March 26, 2018, to February 14, 2020. The 122 participants  were recruited from the community via social media and  public transit advertisements and equally randomized to the  2 treatment groups, which were stratified by sex and  smoking behavior. Eligible participants smoked between 5  and 30 cigarettes per day and drank heavily (&gt;14 drinks per  week for men or &gt;7 drinks per week for women and ≥1 heavy  drinking day [defined as &gt;5 drinks per occasion for men or  &gt;4 drinks per occasion for women] per month for the past  year) and had a desire to quit smoking.&lt;/p&gt;  &lt;p&gt;Interventions: Varenicline tartrate, 1.0 mg, twice daily  or matching placebo pills twice daily for 12 weeks.  Nicotine patch at manufacturer-recommended doses for 10  weeks and brief individual smoking cessation counseling the  week before the quit date and on the quit date.&lt;/p&gt; &lt;p&gt;Main  Outcomes and Measures: The primary outcome was  self-reported continuous cigarette abstinence through weeks  9 to 12; abstinence was biochemically confirmed at the week  12 study visit. Secondary outcomes were the frequency of  weekly drinking and weekly heavy drinking during the study  period.&lt;/p&gt; &lt;p&gt;Results: Among 122 participants (mean [SD]  age, 44.0 [12.4] years; 67 men [54.9%]), 61 were randomly  assigned to receive combined treatment with varenicline and  nicotine patch (varenicline group), and 61 were randomly  assigned to receive placebo and nicotine patch (placebo  group). A total of 54 participants (44.3%) self-identified  as Black, 56 (45.9%) as White, and 12 (9.8%) as other races  (including American Indian or Alaska Native, Asian, &gt;1  race, and unspecified race). A total of 8 participants  (6.6%) self-identified as Hispanic and 114 (93.4%) as  non-Hispanic ethnicity. Study retention to 12 weeks was  89%. The intention-to-treat analyses showed higher smoking  cessation rates during weeks 9 to 12 in the varenicline  group vs the placebo group (27 participants [44.3%] vs 17  participants [27.9%]; odds ratio, 2.20; 95% CI, 1.01-4.80;  P =.047) and lower likelihood of relapse throughout  treatment in the varenicline group relative to the placebo  group (hazard ratio, 0.62; 95% CI, 0.40-0.96; P =.03). Both  treatments were well tolerated; however, compared with  participants in the placebo group, those in the varenicline  group experienced more adverse effects, with 5 participants  in the varenicline group discontinuing medication due to  adverse effects.&lt;/p&gt; &lt;p&gt;Conclusions and Relevance: In this  study, combined treatment with varenicline and nicotine  patch was more effective than placebo and nicotine patch  for smoking cessation among smokers who drink heavily. The  combination treatment had no effect on alcohol consumption,  with both groups showing significant reductions.  Combination treatment with varenicline and nicotine patch  may be a viable option for smokers who drink heavily.&lt;/p&gt;  &lt;p&gt;Trial Registration: ClinicalTrials.gov Identifier: &lt;a  href="https://clinicaltrials.gov/ct2/show/NCT02859142"&gt;NCT02859142&lt;/a&gt;&lt;/p&gt;},
      url = {http://knowledge.uchicago.edu/record/11216},
}