An exploratory short‐term double‐blind randomized trial of varenicline versus nicotine patch for smoking cessation in women. (29th March 2015)

• Record Type: Journal Article
• Authors: Gray, Kevin M.; McClure, Erin A.; Baker, Nathaniel L.; Hartwell, Karen J.; Carpenter, Matthew J.; Saladin, Michael E.
• Is Part Of: Addiction. Volume 110:Number 6(2015:Jun.)
• Page Start: 1027
• Page End: 1034
• Publication Date: 2015-03-29
• Subjects: Alcoholism -- Periodicals; Drug addiction -- Periodicals; 616.86
• DOI: 10.1111/add.12895
• Languages: English
• ISSNs: 0965-2140

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="add12895-sec-0001" sec-type="section"> <title>Aims</title> <p>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.</p> </sec> <sec id="add12895-sec-0002" sec-type="section"> <title>Design</title> <p>Double‐blind double‐dummy randomized trial.</p> </sec> <sec id="add12895-sec-0003" sec-type="section"> <title>Setting</title> <p>Single‐site out‐patient research clinic in the United States.</p> </sec> <sec id="add12895-sec-0004" sec-type="section"> <title>Participants</title> <p>Female smokers, ages 18–45 years and averaging ≥10 cigarettes per day for at least 6 months (<italic>n</italic> = 140).</p> </sec> <sec id="add12895-sec-0005" sec-type="section"> <title>Interventions</title> <p>Participants were randomized to receive a 4‐week course of (a) varenicline tablets and placebo patches (<italic>n</italic> = 67) or (b) placebo tablets and nicotine patches (<italic>n</italic> = 73). Two brief cessation counseling sessions were provided for all participants.</p> </sec> <sec id="add12895-sec-0006" sec-type="section"> <title>Measurements</title> <p>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.</p> </sec> <sec id="add12895-sec-0007" sec-type="section"> <title>Findings</title> <p>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, <italic>P</italic> = 0.011]. One‐week (44.8 versus 20.6%, OR = 3.1, 95% CI = 1.5–6.6, <italic>P</italic> = 0.003) and 4‐week (22.4 versus 9.6%, OR = 2.7, 95% CI = 1.0–7.2, <italic>P</italic> = 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, <italic>P</italic> = 0.126).</p> </sec> <sec id="add12895-sec-0008" sec-type="section"> <title>Conclusion</title> <p>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.</p> </sec> </abstract>