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Long-term Varenicline Treatment for Smoking Cessation
NCT00828113 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00828113
The ClinicalTrials.gov registry entry for NCT00828113 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00828113 reports 2 study locations spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00828113?
The interventions under investigation include: varenicline (DRUG), Individual smoking cessation counseling (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00828113?
This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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