Trials / Completed
CompletedNCT04576949
A Study of Cytisinicline for Smoking Cessation in Adult Smokers
A 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
- 810 (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 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.
Conditions
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
- 2020-10-13
- Primary completion
- 2021-12-23
- Completion
- 2021-12-23
- First posted
- 2020-10-06
- Last updated
- 2026-01-15
- Results posted
- 2024-11-14
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04576949. Inclusion in this directory is not an endorsement.