A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141206
First received: August 30, 2005
Last updated: June 1, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: varenicline (CP-526,555)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Secondary Outcome Measures:
  • Continuous abstinence Weeks 9-52
  • Long-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

Estimated Enrollment: 1005
Study Start Date: May 2003
Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141206

Locations
United States, Arizona
Pfizer Investigational Site
Tucson, Arizona, United States
United States, California
Pfizer Investigational Site
Los Angeles, 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
Upland, California, United States
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States
Pfizer Investigational Site
Great Neck, New York, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States
United States, West Virginia
Pfizer Investigational Site
Morgantown, West Virginia, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00141206     History of Changes
Other Study ID Numbers: A3051028
Study First Received: August 30, 2005
Last Updated: June 1, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014