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NCT01330043 · ClinicalTrials.gov registry record · Phase 4
Extended Treatment for Smoking Cessation
A Phase 4 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 223
- Enrollment target
NCT01330043: Completed Phase 4 study, sponsored by Stanford University.
NCT01330043 is a Phase 4 study that has completed, run by Stanford University. The registered enrollment target is 223 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01330043, a Phase 4 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 223 participants
- Enrollment target
Study Summary
Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.
Primary Outcome
Self-reported no smoking in last 7 days verified by CO\<10 ppm
Interventions
- DRUG Varenicline
- DRUG Bupropion
- DRUG Nicotine patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
What the finished NCT01330043 record still lists
NCT01330043 is an interventional study that assigns participants to a tested intervention. The registered 223 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 (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Varenicline is the first listed.
NCT01330043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01330043 about?
NCT01330043 is a clinical study titled "Extended Treatment for Smoking Cessation". Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment p...
What is the current status of trial NCT01330043?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 223 participants. The study started on 2010-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01330043?
The interventions under investigation include: Varenicline (DRUG), Bupropion (DRUG), Nicotine patch (DRUG).
Who is sponsoring clinical trial NCT01330043?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01330043's enrollment target sits among peer trials
223 383rd of 2000 higher than 1,618 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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