EFFECTIVENESS OF A 16-HOUR TRANSDERMAL NICOTINE PATCH IN A MEDICAL-PRACTICE SETTING, WITHOUT INTENSIVE GROUP-COUNSELING

Background: To determine the effectiveness of a 16-hour transdermal ni cotine patch in assisting smokers to stop smoking, when used in a prim ary medical practice model. Methods: A single-site, randomized, double -blind, outpatient, parallel-group, placebo-controlled trial consistin g of 220 regular, otherwise healthy cigarette smokers. Patients partic ipated in a 12-week patch treatment phase plus a 6-week tapering phase . A standard medical office model of physician intervention, such as c ould easily be employed by any primary care physician, without need fo r any special psychological services, training, or skills, was the beh avioral intervention. Results: Sustained abstinence, determined at eac h 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 ni cotine patch than for those receiving the placebo patch: the percent o f patients not smoking at 6, 12, 18, 26, and 52 weeks was 61% vs 35%, 45% vs 26%, 41% vs 1.6%, 34% vs 12%, and 25% vs 9%, respectively (P<.0 01). This 16-hour nicotine patch produced no systemic side effects and minimal skin irritation. Conclusions: Nicotine replacement therapy vi a a 16-hour transdermal nicotine patch provided safe and effective tre atment for tobacco-dependent patients. One-year sustained nonsmoking r ates were nearly three times higher in the active than in the placebo condition, when the patch was used in an easily applicable standard me dical practice setting, without the need for psychological interventio ns. This outcome was as good as or better than results achieved by nic otine patches using behavior modification or group counseling.