Over-the-counter nicotine patch therapy for smoking cessation: Results from randomized, double-blind, placebo-controlled, and open label trials

Objectives. The purpose of this study was to determine the efficacy and saf ety of the nicotine patch for smoking cessation in an over-the-counter envi ronment. The years of study were 1994 to 1995. Methods. Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958 ) were is years or older, had smoked at least 15 cigarettes daily for at le ast 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide m easurements. Results. Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and p lacebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increa se in adverse cardiovascular events was noted only in the open label-pay gr oup in comparison with the placebo group. Conclusions. In an over-the-counter environment, the 22-mg, 24-hour nicotin e patch is effective and safe for smoking cessation treatment.