6/28/23, 12:29 AM Cytisine for Smoking Cessation Pathway Feedback Search Clinical Topics Home Studies Cytisine for Smoking Cessation Cytisine for Smoking Cessation Disease Tobacco use 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 N = 1310 43.0% male 1310 patients (744 female, 566 male) Inclusion criteria: adult daily smokers who were motivated to quit and called the national quitline Key exclusion criteria: pregnant or breast-feeding, taking smoking-cessation medication, self- reported pheochromocytoma, systolic BP above 150 mmHg, a diastolic BP above 100 mmHg, or both, or 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 40.0 % 40 https://web.pathway.md/studies/recpwJGRlQ1MflY2V 1/2 6/28/23, 12:29 AM Cytisine for Smoking Cessation Pathway 31 30.0 % 20.0 % Significant increase 10.0 % NNH = 11 0.0 % Cytisine Nicotine-replacement therapy 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. Open reference URL https://web.pathway.md/studies/recpwJGRlQ1MflY2V 2/2