A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking Cessation
Intervention: varenicline (CP-526,555) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.
Clinical Details
Official title:
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
Secondary outcome: Continuous abstinence Weeks 9-52Long-term Quit Rate Week 52 Continuous abstinence Weeks 9 -24 7-day Point Prevalence Abstinence Weeks 12, 24, and 52 4-week Point Prevalence Abstinence at Week 52 Minnesota Nicotine Withdrawal Scale Brief Questionnaire of Smoking Urges Smoking Effects Inventory Change from baseline in bodyweight
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
Exclusion Criteria:
- Subjects who have used bupropion (Zyban, or Wellbutrin) previously.
Locations and Contacts
Pfizer Investigational Site, Tucson, Arizona, United States
Pfizer Investigational Site, Los Angeles, California, United States
Pfizer Investigational Site, Upland, California, United States
Pfizer Investigational Site, Newport Beach, California, United States
Pfizer Investigational Site, Riverside, California, United States
Pfizer Investigational Site, San Francisco, California, United States
Pfizer Investigational Site, Farmington, Connecticut, United States
Pfizer Investigational Site, Miami, Florida, United States
Pfizer Investigational Site, Atlanta, Georgia, United States
Pfizer Investigational Site, Chicago, Illinois, United States
Pfizer Investigational Site, Lexington, Kentucky, United States
Pfizer Investigational Site, New Orleans, Louisiana, United States
Pfizer Investigational Site, Worcester, Massachusetts, United States
Pfizer Investigational Site, Omaha, Nebraska, United States
Pfizer Investigational Site, Brooklyn, New York, United States
Pfizer Investigational Site, Great Neck, New York, United States
Pfizer Investigational Site, Portland, Oregon, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania, United States
Pfizer Investigational Site, Salt Lake City, Utah, United States
Pfizer Investigational Site, Morgantown, West Virginia, United States
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting
Related publications: Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55.
Starting date:
May 2003
Ending date: April 2005
Last updated: June 1, 2007
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