To evaluate the efficacy of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year.
Placebo controlled, double blind trial.
Reykjavik health centre.
237 smokers aged 22-66 years living in or around Reykjavik.
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 15mg of nicotine for 3 months, 10mg 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.
The log rank test for 6 years (χ2=8.5, P=0.004) shows a significant association between abstinence from smoking and type of treatment. Sustained abstinence rates for the patch and nasal spray group and patch only group were 51% v 35% after 6 weeks (P=0.011 (χ2), 95% confidence interval 1.17% to 3.32%), 37% v 25% after 3 months (P=0.045, 1.01% to 3.08%), 31% v 16% after 6 months (P=0.005, 1.27% to 4.50%), 27% v 11% after 12 months (P=0.001, 1.50% to 6.14%), and 16% v 9% after 6 years (P=0.077, 0.93% to 4.72%).
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.
- Combined methods of nicotine replacement therapy have a potential advantage over one method because of high levels of substitution
- Nicotine patches release nicotine slowly, but nicotine nasal spray delivers nicotine more rapidly, enabling the smoker to respond quickly to any smoking urges
- Treatment with a patch and nicotine nasal spray was significantly more effective than patch and placebo from day 15 after stopping smoking
- Using a patch for 5 months with a nicotine nasal spray for 1 year provides a more effective means of stopping smoking than using a patch only
- It is not cost effective to use a nicotine nasal spray for longer than 7 months after stopping a patch