An exploratory short-term double-blind randomized trial of varenicline versus nicotine patch for smoking cessation in women.

Aims Within a parent study examining ovarian hormone effects on smoking cessation in women, we conducted an exploratory short-term trial of varenicline versus transdermal nicotine patch. Design Double-blind double-dummy randomized trial. Setting Single-site out-patient research clinic in the United States. Participants Female smokers, ages 18-45 years and averaging ≥10 cigarettes per day for at least 6 months ( n = 140). Interventions Participants were randomized to receive a 4-week course of (a) varenicline tablets and placebo patches ( n = 67) or (b) placebo tablets and nicotine patches ( n = 73). Two brief cessation counseling sessions were provided for all participants. Measurements The outcome of primary clinical interest was 2-week end-of-treatment abstinence. Secondary outcomes included 1- and 4-week end-of treatment abstinence and abstinence at a post-treatment follow-up visit occurring 4 weeks after treatment conclusion. Breath carbon monoxide (≤ 10 parts per million) was used to confirm biochemically self-reported abstinence. Findings Two-week end-of-treatment abstinence was achieved by 37.3% (25 of 67) of varenicline participants and by 17.8% (13 of 73) of nicotine patch participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 1.3-6.0, P = 0.011]. One-week (44.8 versus 20.6%, OR = 3.1, 95% CI = 1.5-6.6, P = 0.003) and 4-week (22.4 versus 9.6%, OR = 2.7, 95% CI = 1.0-7.2, P = 0.043) end-of-treatment abstinence similarly favored varenicline, although post-treatment follow-up Russell Standard abstinence was not significantly different between groups (23.9 versus 13.7%, OR = 2.0, 95% CI = 0.8-4.7, P = 0.126). Conclusion In an exploratory 4-week head-to-head trial in female smokers, varenicline, compared with nicotine patch, more than doubled the odds of end-of-treatment abstinence, although this diminished somewhat at post-treatment follow-up. [ABSTRACT FROM AUTHOR]