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NCT00828113 · ClinicalTrials.gov registry record · Phase 4
Long-term Varenicline Treatment for Smoking Cessation
A Phase 4 study of Smoking, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
- 2
- Study locations
NCT00828113: Completed Phase 4 study of Smoking, sponsored by University of Wisconsin, Madison.
NCT00828113 is a Phase 4 study of Smoking that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 101 participants, below the 454-participant average among 123 other Smoking trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00828113, a Phase 4 study of Smoking, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.
Primary Outcome
Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52
Conditions Studied
Interventions
- DRUG varenicline
- BEHAVIORAL Individual smoking cessation counseling
Study Locations (2)
Wisconsin
- Center for Tobacco Research and Intervention - Madison
- Center for Tobacco Research and Intervention - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-02 |
| Phase | Phase 4 |
What the finished NCT00828113 record still lists
NCT00828113 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 454-participant average among 123 other Smoking trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Smoking appearing as the primary indexed condition, and to 2 interventions - of which varenicline is the first listed.
NCT00828113 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00828113 about?
NCT00828113 is a clinical study titled "Long-term Varenicline Treatment for Smoking Cessation". This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 1...
What is the current status of trial NCT00828113?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2009-01. Estimated completion is 2011-02.
What conditions does trial NCT00828113 study?
This clinical trial studies the following conditions: Smoking.
What interventions are being tested in trial NCT00828113?
The interventions under investigation include: varenicline (DRUG), Individual smoking cessation counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT00828113?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00828113 being conducted?
This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00828113's enrollment target sits among peer trials
101 72nd of 123 higher than 52 of 123 other Smoking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking 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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