12 Week Evaluation of the Safety and Efficacy of a Flexible Dose 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: NCT00150228
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 was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 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 A3051019

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 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 a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation
Study Start Date : December 2001
Actual Study Completion Date : September 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 4-7 and 9-12 .

Secondary Outcome Measures :
  1. Continuous abstinence rate from target quit date to end of treatment (Week 12)
  2. 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 baseline

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 an average of at least ten cigarettes per day during the past year
  • No period of abstinence greater than three months in the past year

Exclusion Criteria:

  • Subjects with history of clinically significant cardiovascular disease
  • Subjects with 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): NCT00150228

United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States
United States, Minnesota
Pfizer Investigational Site
Albert Lea, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States
United States, Wisconsin
Pfizer Investigational Site
La Crosse, Wisconsin, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00150228     History of Changes
Other Study ID Numbers: A3051016
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: June 4, 2007
Last Verified: May 2007

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