A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation. T. Blöndal, M. Franzon, A. Westin. ERS Journals Ltd 1997. ABSTRACT: The objective of the study was to evaluate the therapeutic efficacy of nicotine nasal solution (NNS) for smoking cessation from the stopping day up to 3 months. We also followed the participants for 2 yrs after ceasing smoking to assess what happens after stopping using NNS.In a placebo-controlled, double-blind, 2 yr prospective study, 157 smokers were given either NNS, one dose containing 1 mg of nicotine per 100 µL (n=79), or placebo (n=78). Treatment was continued for up to 1 yr.One day after quitting smoking, the average number of daily doses was 11 in the group assigned NNS and 14 in the group assigned the placebo, and after 6 weeks, 14 and 6 doses, respectively, among abstinent participants still using spray. After 3 months, 65% of the abstainers in the nicotine group were still using the NNS. The abstinence rates were 51, 39 and 29% after 6 weeks, 3 and 6 months, respectively, as compared to 24, 19 and 18% in the placebo group (p=0.0003; p=0.003; p=0.050). The proportion abstinent at the 1 yr (25 vs 17%) and 2 yr follow-ups (19 vs 14%) was higher among those assigned to the nicotine than to the placebo group, but not significantly so for the numbers used in the study.In conclusion, the use of nicotine nasal spray significantly increased the abstinence rate during the first 6 months following the quitting day. Eur Respir J 1997; 10: 1585-1590 The use of nicotine combined with group support during the initial period after stopping smoking, has been shown to be of value in numerous investigations. Nicotine polacrilex gum and nicotine transdermal patches [1,2] are well established as aids to smoking cessation. Other nicotine delivery systems include nasal spray [3][4][5], which has now been approved for use in 11 countries, and a nicotine inhaler [6].The aim of this study was to investigate the effect of a nicotine nasal spray (NNS) in the withdrawal phase of smoking cessation. Nicotine absorption is slow from nicotine polacrilex gum and particularly so from the transdermal patch. The serum nicotine levels attained are far below pretreatment smoking levels. Serum nicotine levels in gum users are seldom more than one third those of smoking levels [1], while the nicotine from nasal sprays is absorbed sufficiently rapidly to produce subjective effects similar to those from smoking and produce blood levels of ~40% of the smoking range [3,7].We attempted to investigate the effect of nicotine nasal spray treatment for up to 3 months and to assess the abstinence rates up to 1 yr after stopping the use of nicotine spray (2 yrs after quitting smoking).
Methods
Subjects and randomizationRecruitment for the study was done by newspaper advertisement in the second half of 1989. To be eligible, subjects had to be 21-68 yrs old and had to smoke at least 1 cigarette·day -1 . Subjects had to be motivated to stop smoking and be willing to adhere to the trial protocol. The ...