At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Current daily smoker averaging ≥10 cigarettes per day (confirmed by 7-day screening diary)
- ✓Exhaled CO ≥10 ppm
- ✓Failed at least one previous smoking cessation attempt
- ✕More than one study participant in same household during 12-week treatment period
- ✕Previous cytisinicline or cytisine use
- ✕Known hypersensitivity to cytisinicline or excipients
- ✕Positive urine drug screen within 28 days of first dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Second 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 792 participants across 12 sites.
Detailed Summary
This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline 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.