Extended-duration transdermal nicotine therapy was more effective than standard-duration therapy for smoking cessation

Randomized controlled trial. ClinicalTrials.gov NCT00364156.

Concealed.*

Blinded (participants, study personnel, data collectors, and outcome assessors).*

52 weeks.

University hospital in Philadelphia, USA.

575 adults 18 to 65 years of age (mean age 45 y, 55% men) who smoked ≥ 10 cigarettes/d for ≥ 1 year. Exclusion criteria included comorbid conditions, pregnancy or lactation, use of other medications, and drug or alcohol dependence.

Transdermal 21-mg nicotine patch once daily for 24 weeks (extended duration, n = 288) or 8 weeks (standard duration, n = 287). After 8 weeks, the standard-duration group received placebo patches to maintain blinding. Both groups received 8 sessions of behavioral counseling.

Primary outcome was 7-day point-prevalence self-reported abstinence from smoking, verified by carbon monoxide level ≤ 10 ppm. Secondary outcomes included self-reported continuous abstinence (not a single puff after the quit date), prolonged abstinence (no relapse [7 consecutive d of smoking] after the first 14 d), time to relapse, and side effects.

75% at 24 weeks and 71% at 52 weeks. Participants lost to follow-up were considered to be smoking. 99% were included in the intention-to-treat analysis.

At week 24, the extended-duration group had higher rates for all measures of abstinence (Table). At week 52, groups differed only for prolonged abstinence (Table). Time to relapse was similar between groups in the first 8 weeks and between weeks 25 and 52; the rate of relapse was slower in the extended-duration group between weeks 9 and 24 (hazard ratio 0.50, 95% CI 0.35 to 0.73). 50% of each group reported serious symptoms. Sleep problems were more frequently reported by the extended-duration group at week 1 (7.7% vs 2.8%) but not at week 12 (1.1% vs 4.5%).

Extended-duration transdermal nicotine therapy was more effective than standard-duration therapy for smoking cessation during the treatment period but not 6 months later.