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A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 312 |
| Start date | 2011-04 |
| Completion | 2018-01 |
Conditions
- Smoking Cessation
Interventions
- Varenicline 1mg BID
- Varenicline 0.5mg BID
- Placebo
Primary outcomes
- 4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12 — Week 9 through Week 12
The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).
Countries
United States, Canada, Georgia, Russia, South Korea, Taiwan