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

Addiction. 2015 Jun;110(6):1027-34. doi: 10.1111/add.12895. Epub 2015 Mar 29.


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.

Trial registration: NCT00664755.

Keywords: Gender; NRT; nicotine; nicotine patch; pharmacotherapy; randomized clinical trial; tobacco; varenicline; women.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Nicotinic Agonists / administration & dosage*
  • Nicotinic Agonists / adverse effects
  • Smoking Cessation / methods*
  • Smoking Prevention
  • Tobacco Use Cessation Devices*
  • Treatment Outcome
  • Varenicline / administration & dosage*
  • Varenicline / adverse effects
  • Young Adult


  • Nicotinic Agonists
  • Varenicline

Associated data