Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
NCT ID: NCT00691483
Last Updated: 2015-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
659 participants
INTERVENTIONAL
2008-09-30
2009-12-31
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
TRIPLE
Study Groups
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placebo
placebo
placebo tablet taken orally twice daily for 12 weeks
varenicline
varenicline
varenicline tablets, 1 mg taken orally twice daily for 12 weeks
Interventions
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placebo
placebo tablet taken orally twice daily for 12 weeks
varenicline
varenicline tablets, 1 mg taken orally twice daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 to 75 yrs old
* Motivated to stop smoking
* Smoke at least 10 cigarettes/day
Exclusion Criteria
* Severe or unstable cardiovascular or pulmonary disease
* Current or recent treatment to stop smoking
* Previous use of varenicline
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Litchfield Park, Arizona, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Santa Ana, California, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Milford, Massachusetts, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Endwell, New York, United States
Pfizer Investigational Site
Bridgeville, Pennsylvania, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Santo André, São Paulo, Brazil
Pfizer Investigational Site
Calgary, Alberta, Canada
Pfizer Investigational Site
Québec, Quebec, Canada
Pfizer Investigational Site
Shenyang, Liaoning, China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Guangzhou, , China
Pfizer Investigational Site
Brno, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Caen, , France
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Göttingen, , Germany
Pfizer Investigational Site
Budapest, , Hungary
Pfizer Investigational Site
Debrecen, , Hungary
Pfizer Investigational Site
Pisa, , Italy
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Gwei Shan Township, Taoyuan County, , Taiwan
Pfizer Investigational Site
Kaohsiung City, , Taiwan
Pfizer Investigational Site
London, , United Kingdom
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.
Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. J Subst Abuse Treat. 2014 Feb;46(2):264-7. doi: 10.1016/j.jsat.2013.08.015. Epub 2013 Sep 24.
Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051095
Identifier Type: -
Identifier Source: org_study_id