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One-Year Outcome and Percentage of Nicotine Replacement

Richard D. Hurt, MD; Lowell C. Dale, MD; Paul A. Fredrickson, MD; Casey C. Caldwell, MD; Gary A. Lee, MD; Kenneth P. Offord, MS; Gary G. Lauger, MS; Zrinka Marsi, MS; Lewis W. Neese, MD; Thomas G. Lundberg, MD

JAMA. 1994;271(8):595-600.

Abstract
Objective.
—To determine the efficacy of a 22-mg nicotine patch combined with the National Cancer Institute program for physician advice and nurse follow-up in providing withdrawal symptom relief, 1-year smoking cessation outcome, and percentage of nicotine replacement.

Design.
—Randomized, double-blind, placebo-controlled trial.

Subjects.
—Two-hundred forty healthy volunteers who were smoking at least 20 cigarettes per day.

Interventions.
—Based on the National Cancer Institute program, subjects received smoking cessation advice from a physician. Follow-up and relapse prevention were provided by a study nurse during individual counseling sessions. Subjects were randomly assigned to 8 weeks of a 22-mg nicotine or placebo patch.

Main Outcome Measures.
—Abstinence from smoking was verified by expired air carbon monoxide levels. Withdrawal symptoms were recorded during patch therapy, and the percentage of nicotine replacement was calculated by dividing serum nicotine and cotinine levels at week 8 of patch therapy by levels obtained while smoking.

Results.
—Higher smoking cessation rates were observed in the active nicotine patch group at 8 weeks (46.7% vs 20%) (P<.001) and at 1 year (27.5% vs 14.2%) (P=.011). Higher smoking cessation rates were also observed in subjects assigned to the active patch who had lower serum levels of nicotine and cotinine at baseline, and withdrawal symptom relief was better in the active patch group compared with placebo.

Conclusions.
—Clinically significant smoking cessation can be achieved using nicotine patch therapy combined with physician intervention, nurse counseling, follow-up, and relapse prevention. Smokers with lower baseline nicotine and cotinine levels had better cessation rates, which provides indirect evidence that they had more adequate nicotine replacement with this fixed dose of transdermal nicotine than those smokers with higher baseline levels.

(JAMA. 1994;271:595-600)

Author Affiliations
From the Nicotine Dependence Center (Drs Hurt, Dale, and Lundberg), the Section of Biostatistics (Mr Offord and Ms Marsi), and the Division of Thoracic Diseases and Internal Medicine (Mr Lauger and Dr Neese), Mayo Clinic and Mayo Foundation, Rochester, Minn; the Nicotine Dependence Center, Mayo Clinic Jacksonville (Fla) (Drs Fredrickson and Lee); and the Division of Community Internal Medicine, Mayo Clinic Scottsdale (Ariz) (Dr Caldwell).

Footnotes
Reprint requests to Mayo Clinic, 200 First St SW, Rochester, MN 55905 (Dr Hurt).

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