At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Current daily cigarette smokers averaging ≥10 cigarettes per day (verified by 7-day diary) who intend to quit
- ✓Expired air carbon monoxide ≥10 ppm
- ✓Failed at least one previous quit attempt with or without therapeutic support
- ✕Previous cytisinicline treatment in a clinical study or any other cytisine usage
- ✕Known hypersensitivity to cytisinicline or excipients
- ✕Positive urinary drug screen within 28 days before first dose
- ✕Clinically significant abnormal serum chemistry or hematology within 28 days of randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
In Brief
A Phase 3 clinical trial evaluating Cytisinicline, Placebo, and 1 other intervention for Smoking Cessation. Completed, enrolled 810 participants across 17 sites.
Detailed Summary
This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline 3 times daily (TID) for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for treatment duration of 84 days/12 weeks.
Study Details
Timeline
Interventions
film-coated oral tablets containing 3 mg cytisinicline
film-coated oral tablets containing matched placebo
Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.