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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00143364
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 4, 2007
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1005 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2003
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Secondary Outcome Measures :
  1. Continuous abstinence Weeks 9-52
  2. Long-term Quit Rate Week 52
  3. Continuous abstinence Weeks 9 -24
  4. 7-day Point Prevalence Abstinence Weeks 12, 24, and 52
  5. 4-week Point Prevalence Abstinence at Week 52
  6. Minnesota Nicotine Withdrawal Scale
  7. Brief Questionnaire of Smoking Urges
  8. Smoking Effects Inventory
  9. Change from baseline in bodyweight

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143364


Locations
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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
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00143364    
Other Study ID Numbers: A3051036
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: June 4, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs