Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 4, 2025
Date Accepted: Dec 18, 2025
Efficacy, safety and economic impact of cytisinicline maintenance therapy in patients who are candidates for smoking cessation. Protocol for a phase IV, multicentre, randomised, open-label, controlled, parallel clinical trial. CITISILONG trial
ABSTRACT
Background:
Cytisynicline has proven to be an effective, efficient and safe molecule in smoking cessation. However, the established 25-day regimen could be insufficient in a high percentage of smokers, so it is necessary to study maintained therapies of this drug.
Objective:
To compare the efficacy of the cytisinicline regimen used in routine clinical practice with two maintained regimens of 50 and 75 days, respectively. In addition, the safety and economic impact of each regimen will be determined.
Methods:
A prospective, multicentre, open-label, controlled, parallel, phase IV clinical trial of 402 smoker patients prepared to quit smoking. Participants will be randomised to three groups in a 1:1:1 ratio, to receive cytisynicline in a clinical practice regimen (25 days) or cytisynicline in a maintained regimen (50 and 75 days respectively). The study was conducted in 10 hospitals in Spain
Results:
Recruitment for the trial and patient enrolment will be completed in May 2026. Follow-up of all participants will extend to June 2027.
Conclusions:
In conclusion, this study evaluates the optimisation of cytisinicline in daily clinical practice, increasing the benefits of its pharmaceutical properties without affecting patient safety. Clinical Trial: European Clinical Trials Register with EUDRACT code 2024-518936-36-00.
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