Transdermal Nicotine for 24 Weeks vs 8 Weeks May Improve Abstinence
February 2, 2010 — Transdermal nicotine for 24 weeks compared with 8 weeks is more effective in achieving and maintaining abstinence and reduces the risk for lapses in smoking, according to the results of a parallel randomized, double-blinded, placebo-controlled trial reported in the February 2 issue of the Annals of Internal Medicine.
"Tobacco dependence is a chronic, relapsing condition that may require extended treatment," write Robert A. Schnoll, PhD, from the University of Pennsylvania in Philadelphia, and colleagues. "We evaluated the relative efficacy of extended (24 weeks) versus standard (8 weeks) transdermal nicotine therapy for promoting biochemically confirmed point-prevalence abstinence at weeks 24 and 52 among adult smokers."
From September 2004 to February 2008, a total of 568 adult smokers seen at an academic center were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks), with use of an unstratified small block–randomization scheme.
The main endpoint of the study was biochemically confirmed point-prevalence abstinence at weeks 24 and 52, and secondary endpoints were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, adverse effects, and adherence.
Compared with standard therapy, extended therapy was associated with higher rates at week 24 of point-prevalence abstinence (31.6% vs 20.3%; odds ratio [OR], 1.81; 95% confidence interval [CI], 1.23 - 2.66; P = .002), prolonged abstinence (41.5% vs 26.9%; OR, 1.97; CI, 1.38 - 2.82; P = .001), and continuous abstinence (19.2% vs 12.6%; OR, 1.64; CI, 1.04 - 2.60; P = .032). The extended therapy group also had lower risk for lapse (hazard ratio [HR], 0.77; 95% CI, 0.63 - 0.95; P = .013), higher likelihood of recovery from lapses (HR, 1.47; 95% CI, 1.17 - 1.84; P = .001), and slower time to relapse (HR, 0.50; 95% CI, 0.35 - 0.73; P < .001).
However, at week 52, extended therapy was associated with higher quit rates only for prolonged abstinence (P = .027). The extended-treatment evaluation revealed no between-group differences in adverse effects and adverse events.
"Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy," the study authors write. "Additional research on the optimal duration of therapy and the possible addition of other treatment components (for example, more intensive counseling, precessation use of nicotine patches) from an efficacy, patient acceptance, and cost perspective should be a priority."
Limitations of this study include low generalizability because participants were smokers without medical comorbid conditions who were seeking treatment, and also there were differences in adherence between treatment groups.
"Some participants did not provide complete abstinence data," the editors write. "Extended therapy with transdermal nicotine helps some adults quit smoking, but benefits may persist only while treatment is maintained."
The National Cancer Institute and the National Institute on Drug Abuse, National Institutes of Health, supported this study. The senior study author (Caryn Lerman, PhD) has disclosed various financial relationships with GlaxoSmithKline, AstraZeneca, Pfizer, and Novartis.
Ann Intern Med. 2010;152:144-151.
Additional Resources
Futher information on tobacco cessation programs for healthcare professionals to access and for clinicians to distribute to patients is available online.
Clinical Context
Transdermal nicotine therapy has been demonstrated to help cigarette smokers quit, and current guidelines recommend 8 weeks of treatment for patients attempting smoking cessation. The authors of the current research hypothesize that a longer duration of treatment with transdermal nicotine therapy might improve smoking cessation outcomes, although a previous trial comparing 8 weeks vs 22 weeks of transdermal nicotine therapy found no difference in the rate of continuous abstinence from smoking between groups.
The current study compares transdermal nicotine therapy for 8 weeks vs a treatment duration of 24 weeks, and it features a dosing methodology as well as outcome assessment that differs from the previous trial.
The current study compares transdermal nicotine therapy for 8 weeks vs a treatment duration of 24 weeks, and it features a dosing methodology as well as outcome assessment that differs from the previous trial.
Study Highlights
- Study subjects were recruited at 1 academic center among adults between the ages of 18 and 65 years who smoked at least 10 cigarettes daily for the last year. Patients with significant medical or psychiatric illness were excluded from the study protocol.
- Participants were randomly assigned to receive 21-mg transdermal nicotine patches for 24 weeks, or 8 weeks of active patches plus 16 weeks of placebo patches. The patches were changed every 24 hours, and there was no tapering at the end of treatment.
- All participants received 8 behavioral counseling visits to stop smoking. Transdermal nicotine therapy was initiated on a prearranged quit date.
- The primary study outcome was 7-day point prevalence abstinence from smoking at study weeks 24 and 52, which was verified with exhaled carbon monoxide levels. Researchers also followed rates of continuous abstinence and time to relapse.
- 568 smokers provided data for study analysis. The mean age of participants was 44.8 years, and 44.7% of the study cohort consisted of women. The mean number of cigarettes smoked per day was 21.2.
- Study completion rates were higher at 24 weeks in comparing the extended therapy group vs the standard therapy group (91% vs 83%, respectively) but were similar at week 52. Adherence to study patches at 24 weeks was 25% and 40% in the standard and extended therapy groups, respectively.
- Point-prevalence abstinence rates at week 24 favored extended treatment vs standard therapy (31.6% vs 20.3%, respectively), whereas this outcome was similar between groups at week 52 (14.5% and 14.3%, respectively).
- Rates of abstinence from the quit date to week 24 (continuous abstinence) were also higher in the extended treatment group, but this result did not remain valid at week 52. Prolonged abstinence between study groups between weeks 2 and 52 was superior in the extended therapy group vs the standard treatment group.
- Extended nicotine therapy was also associated with a longer time to relapse between weeks 9 to 24 and increased speed of recovery from relapse during this period.
- There were 3 serious adverse events in the extended therapy group and 1 serious adverse event in the standard therapy group. All of these events occurred before 8 weeks. Rates of other adverse events were generally similar between randomized groups.
- The incremental cost of extended vs standard therapy was $2482 for each additional quitter gained through a longer duration of treatment.
Clinical Implications
- The current recommended treatment duration of transdermal nicotine therapy for smoking cessation is 8 weeks.
- In the current study, extended treatment with transdermal nicotine therapy for 24 weeks was associated with improved point-prevalence abstinence and continuous abstinence rates vs standard therapy at 24 weeks, but not at 52 weeks. Extended therapy also improved the time to relapse during active treatment vs placebo.
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