For smoking cessation, varenicline combined with a nicotine patch was more effective than nicotine patch with placebo among smokers who drank heavily. These findings, from a randomized, double-blind, placebo-controlled, superiority clinical trial, were published in JAMA Network Open.
Participants were recruited via social media and public transportation advertisements for this study between 2018 and 2020 by investigators at the University of Chicago. Individuals who smoked 5 to 30 cigarettes per day, met the criteria for hazardous drinking levels, and wanted to quit smoking were randomized to receive varenicline (n=61) or placebo (n=61) plus 2 sessions of brief behavioral therapy and nicotine patch for 12 weeks. Varenicline was titrated from 0.5 mg once daily for 3 days to 0.5 mg twice daily for 4 days to 1.0 mg twice daily for the remaining of the 12 weeks. Participants were assessed for smoking cessation and alcohol consumption.
Study participants were aged mean 44.0 (standard deviation [SD], 12.4) years, 45.1% were women, 45.9% were White, 44.3% were Black, they had been smoking for 25.2 (SD, 13.2) years, they smoked 11.8 (SD, 6.6) cigarettes per day, consumed 5.7 (SD, 4.0) drinks per day, and drank 4.5 (SD, 1.8) days per week. Study groups were well balanced for baseline characteristics.
Smoking cessation rates during weeks 9 to 12 were higher among the varenicline recipients (44.3% vs 27.9%; odds ratio [OR], 2.20; 95% CI, 1.01-4.80; P =.047). Varenicline was associated with decreased risk for smoking relapse throughout the 12 weeks (hazard ratio [HR], 0.62; 95% CI, 0.40-0.96; P =.03).
Among all participants, weekly drinking days decreased by 25% (P =.003) and weekly heavy drinking days by 54% (P =.004). Stratified by treatment, no group difference was observed for heavy drinking days (P =.57).
Varenicline recipients reported more nausea (55.7% vs 29.5%; P =.003), gas (49.2% vs 27.9%; P =.009), abnormal dreams (73.8% vs 49.2%; P =.007), sleep problems (50.8% vs 24.6%; P =.003), and headaches (42.6% vs 23.0%; P =.02). Among the varenicline cohort, 8.2% discontinued treatment due to adverse effects and 9.8% asked for a 50% dose reduction.
This study was limited by power, in which the investigators could not assess subgroup differences.
The study authors concluded, “The findings of this randomized clinical trial indicate that, among smokers who drink heavily, more than 50% of whom had alcohol use disorder, the combination of varenicline and nicotine patch treatment (vs placebo and nicotine patch) produced higher smoking cessation rates throughout 12 weeks of treatment. The combination pharmacotherapy was also safe and well-tolerated. The results support continued investigation of varenicline with nicotine patch as a combination treatment strategy for smokers with hazardous drinking behaviors who have historically experienced worse outcomes with standard approved tobacco cessation treatments.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
King A, Vena A, de Wit H, Grant JE, Cao D. Effect of combination treatment with varenicline and nicotine patch on smoking cessation among smokers who drink heavily: a randomized clinical trial. JAMA Netw Open. 2022;5(3):e220951. doi:10.1001/jamanetworkopen.2022.0951