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NCT01078298 · ClinicalTrials.gov registry record · Phase 4
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 525
- Enrollment target
NCT01078298: Completed Phase 4 study, sponsored by Pfizer.
NCT01078298 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 525 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078298, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 525 participants
- Enrollment target
Study Summary
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.
Primary Outcome
Percentage of participants who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm).
Interventions
- DRUG placebo
- DRUG varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
What the finished NCT01078298 record still lists
NCT01078298 is an interventional study that assigns participants to a tested intervention. The registered 525 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01078298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01078298 about?
NCT01078298 is a clinical study titled "Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression". Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses ...
What is the current status of trial NCT01078298?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 525 participants. The study started on 2010-03. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01078298?
The interventions under investigation include: placebo (DRUG), varenicline (DRUG).
Who is sponsoring clinical trial NCT01078298?
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 NCT01078298's enrollment target sits among peer trials
525 157th of 2000 higher than 1,844 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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