Postintervention effect of nicotine replacement therapy on smoking reduction in smokers who are unwilling to quit: randomized trial

Abstract

The objective of this study was to assess the post-intervention effect of nicotine replacement therapy on reduction of cigarette consumption 1.5 years after the end of a 6-month treatment. Heavy smokers who had no intention of quitting smoking were recruited from the general population and were randomly assigned to a treatment of nicotine (choice of a 15-mg nicotine patch, a 4-mg nicotine gum, and/or a 10-mg nicotine inhaler, n = 265), matching placebo products (n = 269), or no intervention (n = 389). Products were sent to participants by mail. Education was limited to a booklet. Of 923 participants, 879 (95%) were followed 6 months after randomization and 846 (92%) were followed after 26 months. Mean baseline consumption was 30 cigarettes/day in all groups. After 6 months, cigarette consumption had decreased by a mean of 10.9 cigarettes/day in the nicotine group, 8.7 in the placebo group, and 4.9 among controls (P < or = 0.02 for all pairwise comparisons). After 26 months, compared with baseline, cigarette consumption had decreased by a mean of 9.8 cigarettes/day in the nicotine group, 7.7 in the placebo group, and 7.7 among controls (nicotine vs. placebo or control: P < or = 0.03). After 2 years, smoking cessation rates did not differ significantly among groups (nicotine 11.7%, placebo 9.3%, control, 10.0%; P = 0.6). Thus, a slight effect of nicotine replacement therapy on reduction of cigarette consumption was maintained 1.5 years after the end of the 6-month treatment, but the initially observed placebo effect was not maintained. Nicotine replacement therapy for smoking reduction had no deleterious impact on smoking cessation.