A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation
Sponsor study identifier
interventional
300
1 country
7
Study Start
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2002
Actual (reported)The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2002
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
September 2002
Actual (reported)September 6, 2005
Actual (reported)September 8, 2005
Actual (reported)4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
Continuous abstinence rate from target quit date to end of treatment (Week 12)
7-day point prevalence of abstinence at Week 12
Number of cigarettes smoked per day
Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
Rewarding effects of smoking assessed by Smoking Effects Inventory
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Albert Lea, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Providence, Rhode Island, United States
Pfizer Investigational Site
La Crosse, Wisconsin, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
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.
Niaura R, Hays JT, Jorenby DE, Leone FT, Pappas JE, Reeves KR, Williams KE, Billing CB Jr. The efficacy and safety of varenicline for smoking cessation using a flexible dosing strategy in adult smokers: a randomized controlled trial. Curr Med Res Opin. 2008 Jul;24(7):1931-41. doi: 10.1185/03007990802177523. Epub 2008 May 29.
Pfizer CT.gov Call Center
Pfizer
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
September 2002
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
June 4, 2007
Record last verified: 2007-05
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Source: ClinicalTrials.gov.
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