Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
479actual
Sites
29
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-05-28 | actual | When the study began enrolling |
| Primary completion | 2025-09-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-06 | actual | The whole study's end, after follow-up |
| First posted | 2024-05-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Smoking Cessation
- Vaping Cessation
Intervention
- Drug: Cytisinicline — also filed as Cytisine
Primary outcome
what the primary-completion date above is the date OFIncidence Rate of Treatment Emergent Serious Adverse Events (SAEs)
measured up to Week 52
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