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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 31, 2005
Last updated: June 1, 2007
Last verified: June 2007
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: June 2003
Study Completion Date: March 2005

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00143364

United States, California
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
San Diego, California, United States
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States
United States, Florida
Pfizer Investigational Site
Pembroke Pines, Florida, United States
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States
United States, Maine
Pfizer Investigational Site
Portland, Maine, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, Minnesota
Pfizer Investigational Site
Albert Lea, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
United States, New York
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00143364     History of Changes
Other Study ID Numbers: A3051036 
Study First Received: August 31, 2005
Last Updated: June 1, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on October 25, 2016