NCT05206370

A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers

A Second Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 792 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Cytisinicline	film-coated oral tablets containing 3 mg cytisinicline
DRUG	Placebo	film-coated oral tablets containing matched placebo
BEHAVIORAL	Behavioral support	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.

Timeline

• Start date: 2022-01-20
• Primary completion: 2023-03-21
• Completion: 2023-03-21
• First posted: 2022-01-25
• Last updated: 2026-01-14
• Results posted: 2026-01-14

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study