Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
101 participants
INTERVENTIONAL
2009-01-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Extended treatment
52-week varenicline therapy + individual smoking cessation counseling
varenicline
Extension of 1 mg twice daily treatment to 52 weeks
varenicline
Double-blind switch to placebo after 12 weeks of open-label therapy
Individual smoking cessation counseling
Brief (\<10 minutes) smoking cessation counseling delivered at clinic visits
Standard treatment
13 weeks of varenicline therapy + individual smoking cessation counseling
varenicline
Extension of 1 mg twice daily treatment to 52 weeks
varenicline
Double-blind switch to placebo after 12 weeks of open-label therapy
Individual smoking cessation counseling
Brief (\<10 minutes) smoking cessation counseling delivered at clinic visits
Interventions
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varenicline
Extension of 1 mg twice daily treatment to 52 weeks
varenicline
Double-blind switch to placebo after 12 weeks of open-label therapy
Individual smoking cessation counseling
Brief (\<10 minutes) smoking cessation counseling delivered at clinic visits
Eligibility Criteria
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Inclusion Criteria
* 5+ cigarettes per day for at least one year
* expired carbon monoxide level of 5+ ppm
Exclusion Criteria
* current or history of psychotic disorder
* current major depressive disorder
* history of suicidal ideation in the previous 3 months
* unstable medical condition
* pregnant, nursing, or planning to become pregnant
* planning to move from study area within 18 months
18 Years
75 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
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Locations
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Center for Tobacco Research and Intervention
Madison, Wisconsin, United States
Center for Tobacco Research and Intervention
Milwaukee, Wisconsin, United States
Countries
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References
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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Other Identifiers
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H-2008-0149
Identifier Type: -
Identifier Source: org_study_id