EFFECT OF NICOTINE NASAL SPRAY ON SMOKING CESSATION - A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY

Background: Nicotine replacement therapies have proved to be of value in smoking cessation. However, not all smokers can use the nicotine gu m or nicotine patch owing to side effects. In addition, the absorption of nicotine from these formulas is slow compared with smoking. A nico tine nasal spray delivers nicotine more rapidly. The objective of this study was to evaluate the efficacy and safety of the nicotine nasal s pray for smoking cessation. Methods: Subjects were recruited through a dvertisements in newspapers and among patients referred to the smoking cessation clinic at Sahlgren's Hospital, Goteborg, Sweden. Two hundre d forty-eight smokers were treated in small groups with eight counseli ng sessions over 6 weeks. At their first group session, subjects were randomized to a group receiving nicotine spray (n=125), 0.5 mg of nico tine per single spray, or to a placebo group (n=123). The procedure wa s double blind. Success rates were measured up to 12 months. The nonsm oking status was verified by expired carbon monoxide less than 10 ppm. Results: Significantly more subjects in the nicotine group were conti nuously abstinent for 12 months than in the placebo group (27% vs 15%; odds ratio, 2.16; 95% confidence interval, 1.15 to 4.12). Ten of the 34 abstinent subjects in the nicotine group used the spray for 1 year. Mild or moderate side effects were rather frequent for bath sprays, b ut they were significantly more for the nicotine spray. Subjects with high scores (>7) on Fagerstrom's tolerance questionnaire had a signifi cantly lower success rate with placebo than with the nicotine spray. F or subjects with low scores, there was no difference. Conclusion: Nico tine nasal spray in combination with group treatment is an effective a id to smoking cessation.