Abstract

This study aimed to assess the efficacy of the nicotine patch for smoking cessation, under simulated conditions of over-the-counter sale, absent any direct instruction or behavioral treatment. In a randomized, double-blind, placebo-controlled, multicenter study, 567 smokers were randomized to an active nicotine patch (n = 283) or placebo (n = 284). Treatment followed a three-step program of 21 mg/day for 6 weeks, 14 mg/day for 2 weeks and 7 mg/day for 2 weeks. Participants received brief written instructions, an audiotape and a written User's Guide. There was no other intervention and no contact with participants between enrollment and the primary outcome assessment at 6 weeks. Analyses were based on intent to treat, with lost subjects counted as failures, and claimed abstinence was verified by carbon monoxide measures. Use of active patch produced significantly higher abstinence rates. Continuous abstinence rates (subject to a 2-week grace period) for nicotine and placebo were 19.4% and 7.0% at 6 weeks (OR = 3.2; 95% CI 1.8-5.4) and 15.2% and 5.3% at 10 weeks (OR = 3.2; 95% CI 1.7-5.9), respectively. Seven-day point-prevalence rates for nicotine and placebo patches were 26.1% and 7.7% at 6 weeks (OR = 4.2; 95% CI 2.5-7.0) and 23.3% and 7.7% at 10 weeks (OR = 3.6; 95% CI 2.2-6.1), respectively. Reported adverse events were mild and consistent with prior observations of nicotine patch use. The nicotine patch was safe and effective for smoking cessation at least during 10 weeks of treatment under open-sale conditions, without face-to-face instruction or counseling.