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

J. Taylor Hays, Ivana T. Croghan, Darrell R. Schroeder, Kenneth P. Offord, Richard D. Hurt, Troy D. Wolter, Mitchell A. Nides, Michael Davidson

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1701-1707
Number of pages7
JournalAmerican journal of public health
Issue number11
StatePublished - Nov 1999


ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

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