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

Mar 3, 2015Addiction (Abingdon, England)

Short-term comparison of varenicline and nicotine patch for quitting smoking in women

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Abstract

Two-week end-of-treatment abstinence was achieved by 37.3% of participants using varenicline compared to 17.8% using the nicotine patch.

Varenicline participants demonstrated significantly higher rates of abstinence at 1 week (44.8% vs. 20.6%) and 4 weeks (22.4% vs. 9.6%) compared to those using nicotine patches.
The odds of achieving 2-week end-of-treatment abstinence were 2.7 times greater for varenicline users than for nicotine patch users.
Post-treatment follow-up abstinence rates were not significantly different between the two groups (23.9% for varenicline vs. 13.7% for nicotine patches).
Self-reported abstinence was confirmed biochemically through breath carbon monoxide measurements.

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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.

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

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