Cytisine for smoking cessation
Trial question
What is the effect of cytisine for smoking cessation?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 1310
1310 patients (744 female, 566 male).
Inclusion criteria: adult daily smokers who were motivated to quit and called the national quitline.
Key exclusion criteria: pregnancy or lactation; taking smoking-cessation medication; self-reported pheochromocytoma, SBP > 150 mmHg, DBP > 100 mmHg, or both; schizophrenia.
Interventions
N=655 cytisine (from day 1, 6 tablets/day through day 25, 2 tablets/day).
N=655 nicotine-replacement therapy (nicotine patches (in doses of 7 mg, 14 mg, or 21 mg) and for gum (2 mg or 4 mg) or lozenges (1 mg or 2 mg) or both gum and lozenges for 25 days).
Primary outcome
Self-reported continuous abstinence at 1 month
40%
31%
40.0 %
30.0 %
20.0 %
10.0 %
0.0 %
Cytisine
Nicotine-replacement
therapy
Significant
increase ▲
NNT = 11
Significant increase in self-reported continuous abstinence at 1 month (40% vs. 31%; RR 1.3, 95% CI 1.1 to 1.5).
Secondary outcomes
Significant increase in continuous abstinence at 6 months (22% vs. 15%; RR 1.4, 95% CI 1.1 to 1.8).
Safety outcomes
Significant differences in self-reported adverse events (31% vs. 20%, p < 0.001), primarily nausea and vomiting and sleep disorders.
Conclusion
In adult daily smokers who were motivated to quit and called the national quitline, cytisine was superior to nicotine-replacement therapy with respect to a self-reported continuous abstinence at 1 month.
Reference
Walker N, Howe C, Glover M et al. Cytisine versus nicotine for smoking cessation. N Engl J Med. 2014 Dec 18;371(25):2353-62.
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