The Collaborative European Anti‐Smoking Evaluation (CEASE) was a European multicentre, randomized, double‐blind placebo controlled smoking cessation study. The objectives were to determine whether higher dosage and longer duration of nicotine patch therapy would increase the success rate. Thirty‐six chest clinics enrolled a total of 3,575 smokers. Subjects were allocated to one of five treatment arms: placebo and either standard or higher dose nicotine patches (15 mg and 25 mg daily) each given for 8 or 22 weeks with adjunctive moderately intensive support. The 12 month sustained success rates were: 25 mg patch for 22 weeks (L‐25), 15.4%; 25 mg patch for 8 weeks (S‐25), 15.9%; 15 mg patch for 22 weeks (L‐15), 13.7%; 15 mg patch for 8 weeks (S‐15), 11.7%; and placebo (P‐0) 9.9% (placebo versus 15 mg, p<0.05; 25 mg versus 15 mg, p<0.03; 25 mg versus placebo, p<0.001, Chi‐squared test). There was no significant difference in success rate between the two active treatment durations. Of the first week abstainers (n=1,698), 25.1% achieved success at 12 months as opposed to first week smokers, 2.7% of 1,877 subjects (p<0.001). In summary, a higher than standard dose of nicotine patch was associated with an increase in the long‐term success in smoking cessation but continuation of treatment beyond 8–12 weeks did not increase the success rates.

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 The log rank test for 6 years ( 2 = 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 ( 2 ), 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%). 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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Nicotine replacement by transdermal patches is more effective than placebo in smoking cessation, but has a low success rate after one year (9-18%). We tested whether this was attributed to insufficient nicotine replacement.We conducted a randomized trial to investigate the effect on outcome of different doses of transdermal nicotine replacement after stratification according to baseline plasma cotinine values. Two hundred and ninety seven adult smokers were enrolled. Those with baseline cotinine ≤250 ng·ml -1 (low cotinine) were randomly assigned to placebo (LC-P) or to 15 mg 16 h nicotine patches (LC-15), and those with baseline cotinine >250 ng·mL -1 (high cotinine) were randomly assigned to 15 mg (HC-15) or 25 mg (HC-25) 16 h nicotine patches. Plasma nicotine and cotinine values, expired carbon monoxide and withdrawal symptoms were measured at scheduled intervals during treatment.Smokers in the LC-15 group had a significantly higher success rate than placebo (28 vs 9%). Smokers with high baseline cotinine had lower success rates, and a high dose of nicotine did not increase success rate (HC-25 9% vs HC-15 11%). Subjects in the HC-15 group had the lowest percentage of nicotine replacement and a higher prevalence of withdrawal symptoms than the HC-25 group. Replacement was similar in groups LC-15 and HC-25, but the success rate was significantly lower in HC-25 group, despite similar levels of withdrawal symptoms.We conclude that a higher success rate was obtained after one year in smokers with low baseline plasma cotinine values. Determination of plasma cotinine values may be, thus, helpful in identifying smokers who could benefit from transdermal nicotine replacement.