NCT06435221

Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers

A Multicenter, Open-Label Study Assessing Long-Term Exposure With Cytisinicline 3 mg TID

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.

Conditions

• Smoking Cessation
• Vaping Cessation

Interventions

Type	Name	Description
DRUG	Cytisinicline	film-coated oral tablets containing 3 mg cytisinicline

Timeline

• Start date: 2024-05-28
• Primary completion: 2025-09-29
• Completion: 2025-10-06
• First posted: 2024-05-30
• Last updated: 2025-11-26

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study