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Clinical Trial
. 1999 Jan 30;318(7179):285-8.
doi: 10.1136/bmj.318.7179.285.

Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up

T Blondal  1 , L J Gudmundsson, I Olafsdottir, G Gustavsson, A Westin
Affiliations
Clinical Trial

Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up

T Blondal et al. BMJ. .

Erratum in

  • BMJ 1999 Mar 20;318(7186):764

Abstract

Objective: To evaluate the efficacy of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year.

Design: Placebo controlled, double blind trial.

Setting: Reykjavik health centre.

Subjects: 237 smokers aged 22-66 years living in or around Reykjavik.

Interventions: Nicotine patch for 5 months with nicotine nasal spray for 1 year (n=118) or nicotine patch with placebo spray (n=119). Treatment with patches included 15 mg of nicotine for 3 months, 10 mg for the fourth month, and 5 mg for the fifth month, whereas nicotine in the nasal spray was available for up to 1 year. Both groups received supportive treatment.

Main outcome measure: Sustained abstinence from smoking.

Results: Sustained abstinence rates for the patch and nasal spray group and patch only group were 51% v 35% after 6 weeks (odds ratio 1.97, 95% confidence interval 1.17% to 3.32; P=0.011(chi2), 37% v 25% after 3 months (1.76, 1.01 to 3.08; P=0.045), 31% v 16% after 6 months (2.40, 1.27 to 4.50; P=0.005), 27% v 11% after 12 months (3.03, 1.50 to 6.14; P=0.001), and 16% v 9% after 6 years (2.09, 0.93 to 4.72; P=0.08) [corrected].

Conclusions: Short and long term abstinence rates show that the combination of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year is a more effective method of stopping smoking than using a patch only. The low percentage of participants using the nasal spray at 1 year, and the few relapses during the second year, suggest that it is not cost effective to use a nasal spray for longer than 7 months after stopping a patch.

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Figures

Figure 1
Figure 1
Flow of participants through trial
Figure 2
Figure 2
Kaplan-Meier survival curves showing difference in abstinence rates between participants allocated nicotine patch and nicotine nasal spray and those allocated nicotine patch only. Number of relapses during the 5 years was 12 v 2 in the treatment and patch only groups respectively (two abstinent participants died during the 6 year follow up period; one in each treatment group)
See this image and copyright information in PMC

Comment in

References

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