THE NICOTINE PATCH IN SMOKING CESSATION - A RANDOMIZED TRIAL WITH TELEPHONE COUNSELING

Background: This study was conducted to determine the efficacy of the nicotine patch in smoking cessation when combined with self-help mater ials, three brief visits, and telephone counseling. Methods: One hundr ed fifty-nine healthy volunteers who smoked at least one pack of cigar ettes per day and desired to quit smoking were enrolled in a double-bl ind trial with 6-week treatment and 6-month-follow-up periods. After r eview of self-help materials, subjects were randomly assigned to regim ens of nicotine or placebo patches. Subjects wore two patches per day for 4 weeks (25 mg of nicotine per 24 hours), then one patch per day f or 2 weeks. Return visits were at the ends of weeks 4 and 6. Telephone counseling was given during weeks 1, 2, 3, and 5. Abstinence at 6 wee ks was defined as zero cigarettes smoked for the previous 28 days, ver ified by exhaled carbon monoxide less than 8 ppm at 4 weeks and 6 week s. Abstinence at 3 and 6 months was defined as self-report of zero cig arettes since the previous contact, verified by carbon monoxide value at 6 months. Results: Abstinence rates at 6 weeks, 3 months, and 6 mon ths were 29.5%, 21.8%, and 20.5% in the active group, and 8.8%, 3.8%, and 2.5% in the placebo group (P less-than-or-equal-to .001 for each c omparison), respectively. Skin irritation was the main side effect, ca using 1.3% to drop out. Conclusion: The nicotine patch is efficacious in smoking cessation over a 6-month period, when combined with only se lf-help materials, three brief visits, and telephone counseling.