Postintervention effect of nicotine replacement therapy for smoking reduction: a randomized trial with a 5-year...

We tested whether a reduction of cigarette consumption obtained after 6 months of nicotine replacement therapy was maintained 5 years after the end of this treatment. Heavy smokers (mean = 30 cigarettes per day) who had no intention of quitting smoking were randomly assigned to a 6-month treatment of nicotine (15-mg patch, 4-mg gum, and/or 10-mg inhaler, n = 265), placebo (n = 269), or no intervention (n = 389). Products were sent by mail, and education was limited to a booklet. Of 923 participants, 879 (95%) were followed after 6 months and 671 (73%) after 5 years. After 6 months, smoking reduction was larger for nicotine (-10.9 cigarettes per day) than for placebo (-8.7) and no treatment (-4.9, all P or= 0.2) and smoking cessation rates (17% to 21%, all P > 0.2) were similar in all groups. In smokers, 5-year continuous abstinence was higher in those who had reduced their cigarette consumption by at least 50% between baseline and 6 months than in those who did not reduce (11.9% vs 5.6%; P = 0.011; odds ratio, 2.3; 95% confidence interval, 1.2-4.2). Thus, the initial effect of the treatment on smoking reduction was not maintained after 5 years. However, reducing cigarette consumption was associated with a higher chance of subsequently quitting smoking. Nicotine replacement therapy in unmotivated smokers had no deleterious effect on dependence levels and smoking behavior.