A Multicenter, Double-blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers

A Multicenter, Double-blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers A Multicenter, Double-blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers This Phase 3 study will evaluate 3 mg cytisinicline TID for a treatment duration of 42 days/6 weeks as well as repeating that duration for a total of 84 days/12 weeks treatment (similar to the duration of varenicline treatment). All subjects will receive standard behavioral support for smoking cessation during the study. Subjects are to be randomized to one of three arms A, B, or C, where the intended interventions are placebo for 12 weeks plus behavioral support (Arm A), 3 mg cytisinicline TID for 6 weeks followed by placebo for 6 weeks plus behavioral support (Arm B), and 3 mg cytisinicline TID for 12 weeks plus behavioral support (Arm C). The primary outcome measure is abstinence during the last 4 weeks of cytisinicline treatment compared to the placebo arm (Weeks 3-6 for comparison of Arm B vs Arm A; Weeks 9-12 for comparison of Arm C vs Arm A). The secondary outcome measure is abstinence continuing to Week 24 post randomization in the cytisinicline arms compared to the placebo arm (Weeks 6-24 for comparison of Arm B vs Arm A; Weeks 12-24 for comparison of Arm C vs Arm A). If the primary outcome of abstinence is significant for both 6 and 12 weeks of cytisinicline treatment, reduction in risk of relapse for those subjects achieving abstinence within a Week 3-6 period will be compared in Arm C vs Arm B from Week 7 to Week 24. In addition, the study will compare the safety profiles of 3 mg TID dosing for 6 weeks (Arm B) and 12 weeks (Arm C), relative to placebo (Arm A).