Objective: To evaluate the smoking cessation efficacy of nicotine patch therapy as an adjunct to low-intensity, primary care intervention. Design: Randomized, placebo-controlled, double-blind, multisite trial. Settings: Twenty-one primary care sites in Nebraska. Patients: A total of 369 smokers of 20 or more cigarettes per day. Intervention: Two brief primary care visits for smoking intervention with 10 weeks of active or placebo patch therapy. Main Outcome Measures: Confirmed self-reported abstinence 3, 6, and 12 months after the quit day. Results: Compared with placebo control subjects, participants assigned nicotine patches had higher 3-month (23.4% vs 11.4%; P<.01) and 6-month (18.5% vs 10.3%; P<.05) abstinence rates. The 1-year abstinence rates for the active and placebo patch groups were 14.7% and 8.7%, respectively (P = .07). Of smokers aged 45 years and older, 9 (18.8%) of 48 using active patches compared with 0 of 31 using placebo patches achieved 12-month abstinence (X2= 6.56; P<.05). Among those with high nicotine dependency scores (Fagerstrom score ≥7), 1-year abstinence rates were significantly higher in the nicotine patch group (19.1%) compared with the placebo group (5.0%) (X2= 10.7; P = .001). However, there was no significant difference in 1-year quit rates for participants with low Fagerstrom scores (<7). Conclusions: Nicotine patch therapy enhanced 6-month quit rates as an adjunct to brief primary care intervention. The highest quit rates were achieved by participants who specifically contacted the site to enroll in the study or to obtain a prescription for nicotine patches. Differences in participant selection factors may account, in part, for the lower smoking cessation rates associated with primary care intervention. Duration of counseling, patient age, and Fagerstrom scores may be important factors related to the long-term smoking cessation success of nicotine patch therapy.
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