12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation
1 other identifier
interventional
625
1 country
13
Brief Summary
The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks 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 A3051018
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2001
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedJune 4, 2007
June 1, 2007
September 6, 2005
June 1, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
Secondary Outcomes (6)
Continuous abstinence rate from target quit date to end of treatment (Week 12)
Carbon monoxide(CO)-confirmed 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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have smoked on average of at least ten cigarettes per day during the past year
- Subjects must have no period of abstinence greater than three months in the past year
You may not qualify if:
- Subjects with any history of clinically significant cardiovascular disease
- Uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (13)
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
San Bernardino, California, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
West Covina, California, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
Jackson, Florida, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Jackson, Mississippi, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Houston, Texas, United States
Related Publications (1)
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.
PMID: 37142273DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
September 1, 2001
Study Completion
October 1, 2002
Last Updated
June 4, 2007
Record last verified: 2007-06