• Kevin M Gray, Erin A McClure, Nathaniel L Baker, Karen J Hartwell, Matthew J Carpenter, and Michael E Saladin.
• Department of Psychiatry and Behavioral Sciences.
• Addiction. 2015 Jun 1; 110 (6): 1027-34.

AimsWithin 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.DesignDouble-blind double-dummy randomized trial.SettingSingle-site out-patient research clinic in the United States.ParticipantsFemale smokers, ages 18-45 years and averaging ≥10 cigarettes per day for at least 6 months (n=140).InterventionsParticipants 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.MeasurementsThe 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.FindingsTwo-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).ConclusionIn 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.© 2015 Society for the Study of Addiction.

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