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NCT01312909 · ClinicalTrials.gov registry record · Phase 4
Smoking Cessation Study In Healthy Adolescent Smokers
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 312
- Enrollment target
NCT01312909: Completed Phase 4 study, sponsored by Pfizer.
NCT01312909 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 312 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01312909, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 312 participants
- Enrollment target
Study Summary
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG Varenicline 1mg BID
- DRUG Varenicline 0.5mg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2011-04 |
| Est. Completion | 2018-01 |
| Phase | Phase 4 |
What the finished NCT01312909 record still lists
NCT01312909 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01312909 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01312909 about?
NCT01312909 is a clinical study titled "Smoking Cessation Study 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.
What is the current status of trial NCT01312909?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 312 participants. The study started on 2011-04. Estimated completion is 2018-01.
What interventions are being tested in trial NCT01312909?
The interventions under investigation include: Placebo (DRUG), Varenicline 1mg BID (DRUG), Varenicline 0.5mg BID (DRUG).
Who is sponsoring clinical trial NCT01312909?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01312909's enrollment target sits among peer trials
312 262nd of 2000 higher than 1,738 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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