This study evaluated cytisine (1.5 mg, escalating/de-escalating schedule) vs. counseling alone for smoking cessation in active smokers enrolled in the Italian RISP lung cancer screening trial, with a primary endpoint of self-reported continuous abstinence in the 2 weeks after completing the cessation program.
Smoking cessation rate was 50.1% with cytisine vs. 8.1% with counseling alone (adjusted OR 14.53, 95% CI 11.67–18.08, p<0.05); cytisine users also had greater cigarette reduction (23.4% vs. 10.0%, p<0.0001). Efficacy and toxicity were similar in adults ≥65 years (n=428).
Primary endpoint relied on self-reported abstinence without biochemical verification for all participants; the cessation program was optional and uptake was voluntary, introducing selection bias (cytisine users had higher pack-years and motivation at baseline); short follow-up window (2 weeks post-program) limits conclusions about long-term abstinence.
Integrating cytisine into a lung cancer screening program can yield cessation rates roughly 6 times higher than counseling alone, and the drug appears effective and safe in adults aged ≥65. Clinicians should counsel women about a higher risk of abdominal discomfort, and monitor for nausea and insomnia, which together drive most of the 15% dropout rate.
