A. Hjalmarson et al., EFFECT OF NICOTINE NASAL SPRAY ON SMOKING CESSATION - A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY, Archives of internal medicine, 154(22), 1994, pp. 2567-2572
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.