Background: To determine the effectiveness of a 16-hour transdermal nicotine patch in assisting smokers to stop smoking, when used in a primary medical practice model.
Methods: A single-site, randomized, double-blind, out-patient, parallel-group, placebo-controlled trial consisting of 220 regular, otherwise healthy cigarette smokers. Patients participated in a 12-week patch treatment phase plus a 6-week tapering phase. A standard medical office model of physician intervention, such as could easily be employed by any primary care physician, without need for any special psychological services, training, or skills, was the behavioral intervention.
Results: Sustained abstinence, determined at each visit by absolutely no cigarette use, carbon monoxide level of 9 ppm or less, and serum cotinine level of 15 ng/mL or less (after week 18), was significantly greater for those patients receiving the active nicotine patch than for those receiving the placebo patch: the percent of patients not smoking at 6, 12, 18, 26, and 52 weeks was 61% vs 35%, 45% vs 26%, 41% vs 16%, 34% vs 12%, and 25% vs 9%, respectively (P < .001). This 16-hour nicotine patch produced no systemic side effects and minimal skin irritation.
Conclusions: Nicotine replacement therapy via a 16-hour transdermal nicotine patch provided safe and effective treatment for tobacco-dependent patients. One-year sustained nonsmoking rates were nearly three times higher in the active than in the placebo condition, when the patch was used in an easily applicable standard medical practice setting, without the need for psychological interventions. This outcome was as good as or better than results achieved by nicotine patches using behavior modification or group counseling.