NICOTINE PATCH THERAPY FOR SMOKING CESSATION COMBINED WITH PHYSICIAN ADVICE AND NURSE FOLLOW-UP - ONE-YEAR OUTCOME AND PERCENTAGE OF NICOTINE REPLACEMENT

Objective.-To determine the efficacy of a 22-mg nicotine patch combine d with the National Cancer Institute program for physician advice and nurse follow-up in providing withdrawal symptom relief, 1-year smoking cessation outcome, and percentage of nicotine replacement. Design.-Ra ndomized, double-blind, placebo-controlled trial. Subjects.-Two-hundre d forty healthy volunteers who were smoking at least 20 cigarettes per day. Interventions.-Based on the National Cancer Institute program, s ubjects received smoking cessation advice from a physician. Follow-up and relapse prevention were provided by a study nurse during individua l counseling sessions. Subjects were randomly assigned to 8 weeks of a 22-mg nicotine or placebo patch. Main Outcome Measures.-Abstinence fr om smoking was verified by expired air carbon monoxide levels. Withdra wal symptoms were recorded during patch therapy, and the percentage of nicotine replacement was calculated by dividing serum nicotine and co tinine levels at week 8 of patch therapy by levels obtained while smok ing. Results.-Higher smoking cessation rates were observed in the acti ve nicotine patch group at 8 weeks (46.7% vs 20%) (P<.001) and at 1 ye ar (27.5% vs 14.2%) (P=.011). Higher smoking cessation rates were also observed in subjects assigned to the active patch who had lower serum levels of nicotine and cotinine at baseline, and withdrawal symptom r elief was better in the active patch group compared with placebo. Conc lusions.-Clinically significant smoking cessation can be achieved usin g nicotine patch therapy combined with physician intervention, nurse c ounseling, follow-up, and relapse prevention. Smokers with lower basel ine nicotine and cotinine levels had better cessation rates, which pro vides indirect evidence that they had more adequate nicotine replaceme nt with this fixed dose of transdermal nicotine than those smokers wit h higher baseline levels.