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A Randomized, Placebo-Controlled, Double-blind Study

David M. Daughton, MS; Scott A. Heatley, MD, PhD; John J. Prendergast, MD; Donna Causey, MD; Mark Knowles, PhD; Clyde N. Rolf, MD; Ron A. Cheney, PA-C; Kathleen Hatlelid, PA-C; Austin B. Thompson, MD; Stephen I. Rennard, MD

Arch Intern Med. 1991;151(4):749-752.

Abstract
To assess the smoking cessation efficacy of transdermal nicotine patches as an adjunct to low-intervention therapy, we conducted a double-blind, placebo-controlled trial in 158 smokers. Participants were randomly assigned to one of the following three study regimens that required daily application of two 15cm² patches: (1) 24-hour nicotine delivery, (2) nicotine delivery during wakeful hours only, and (3) placebo. The impact of the three regimens on smoking cessation rates and tobacco withdrawal symptoms was examined. During the last 2 weeks of the trial, 39% of the 24-hour nicotine regimen delivery group, 35% of those on wakeful hour nicotine regimens, and 13.5% of the placebo treatment group achieved abstinence. Self-reported quit rates for the two nicotine patch-wearing regimens, as compared with that for the placebo group, continued to be significantly higher at 6 months. Moreover, compared with placebo, the transdermal nicotine patches significantly reduced tobacco withdrawal symptoms during the first few weeks of quitting. The differences in quit rates and tobacco withdrawal symptoms between the two active groups were not statistically significant. The patches were well tolerated both topically and systemically. We concluded that transdermal nicotine, when used as an adjunct to low-intervention therapy, significantly reduced tobacco withdrawal symptoms and enhanced smoking cessation rates.

(Arch Intern Med. 1991;151:749-752)

Author Affiliations
From the University of Nebraska Medical Center, Omaha (Messrs Daughton and Cheney, Ms Hatlelid, and Drs Thompson and Rennard), The Pacific Medical Research Services, Redwood City, Calif (Drs Heatley and Prendergast), the ALZA Corp, Palo Alto, Calif (Drs Causey and Knowles), and the Merrell Dow Research Institute, Cincinnati, Ohio (Dr Rolf).

Footnotes
Accepted for publication September 12, 1990.

Reprint requests to Pulmonary and Critical Care Medicine Section, Department of Internal Medicine, University of Nebraska Medical Center, 600 S 42nd St, Omaha, NE 68198-2465 (Mr Daughton).

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