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

J.T. Hays, I.T. Croghan, D.R. Schroeder, K.P. Offord, R.D. Hurt, T.D. Wolter, M.A. Nides and M. Davidson

American Journal of Public Health, 1999, vol. 89, issue 11, 1701-1707

Abstract: Objectives. The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the-counter environment. 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 18 years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements. 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 placebo 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 increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group. Conclusions. In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment.

Date: 1999
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