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


METHODS
Double-blind double-dummy randomized trial.


METHODS
Single-site out-patient research clinic in the United States.


METHODS
Female smokers, ages 18-45 years and averaging ≥10 cigarettes per day for at least 6 months (n=140).


METHODS
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Department of Psychiatry and Behavioral Sciences.
Kevin M
KM
Gray
Department of Psychiatry and Behavioral Sciences.
Erin A
EA
McClure
Department of Public Health Sciences.
Nathaniel L
NL
Baker
Department of Psychiatry and Behavioral Sciences.|Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, USA.
Karen J
KJ
Hartwell
Department of Psychiatry and Behavioral Sciences.|Hollings Cancer Center.
Matthew J
MJ
Carpenter
Department of Psychiatry and Behavioral Sciences.|Department of Health Sciences and Research, Medical University of South Carolina, Charleston, SC, USA.
Michael E
ME
Saladin
D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D061485:Tobacco Use Cessation Devices; D016896:Treatment Outcome; D000068580:Varenicline / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D018722:Nicotinic Agonists; D000068580:Varenicline
Gender; NRT; nicotine; nicotine patch; pharmacotherapy; randomized clinical trial; tobacco; varenicline; women