Combined Varenicline With Nicotine Patch and Extended Treatment Duration on Smoking Cessation
Baker 2021 trial design and results
Design
Multicentre randomised clinical trial with a factorial design
Treatment
Varenicline plus nicotine patch, and/or 24 weeks of treatment
Control
Varenicline monotherapy, and/or 12 weeks of treatment
Population
1251 adults smoking 5 or more cigarettes a day, mean age 49.1, 54.0% women
Follow-up
52 weeks
Primary endpoint
Seven-day point prevalence abstinence at 52 weeks
Result
No significant interaction between the two treatment factors and no significant differences in abstinence: risk difference 0.4% (95% CI -4.3% to 5.2%), odds ratio 0.99 (0.87 to 1.12). Nausea occurred in 24.0% to 30.9% and insomnia in 24.4% to 30.5% across the four groups.
Secondary endpoints
Adverse effects, adherence, abstinence at earlier timepoints
Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration.
The trial authors, in the published abstract
How it has aged
A clean factorial negative that closes two plausible-sounding escalation strategies at once. Varenicline alone for twelve weeks remains the standard, and more is not better.
Publications
Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial
Baker TB, Piper ME, Smith SS, et al. Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. JAMA 2021 Oct 19;326(15):1485-1493.
No benefit from adding a nicotine patch to varenicline
No benefit from extending treatment from 12 to 24 weeks