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

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 less than or equal to 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 less than or equal to 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.