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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.

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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

FieldValue
Enrollment Target 312 participants
Start Date 2011-04
Est. Completion 2018-01
Phase Phase 4
Pfizer

1,845 total trials

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.

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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Source: ClinicalTrials.gov NCT01312909, the US trial registry maintained by the National Library of Medicine. NCT01312909 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.