12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo 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. Identifier: NCT00150254
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : June 4, 2007
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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

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: CP-526,555 (varenicline) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2001
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Varenicline

Primary Outcome Measures :
  1. 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Secondary Outcome Measures :
  1. Continuous abstinence rate from target quit date to end of treatment (Week 12)
  2. Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12
  3. Number of cigarettes smoked per day
  4. Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
  5. Rewarding effects of smoking assessed by Smoking Effects Inventory
  6. Weight change from baselin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects with any history of clinically significant cardiovascular disease
  • Uncontrolled hypertension

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 identifier (NCT number): NCT00150254

United States, California
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
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States
United States, Florida
Pfizer Investigational Site
Jackson, Florida, 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, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information: Identifier: NCT00150254     History of Changes
Other Study ID Numbers: A3051007
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: June 4, 2007
Last Verified: June 2007

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