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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 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.

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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.

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

FieldValue
Enrollment Target 101 participants
Start Date 2009-01
Est. Completion 2011-02
Phase Phase 4

Sponsor

University of Wisconsin, Madison

1,039 total trials

What the Registry Record Tells You About NCT00828113

The ClinicalTrials.gov registry entry for NCT00828113 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 454-participant average among 123 other Smoking trials with a reported enrollment target (78% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.