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

June 1, 2007 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1005

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States
        • Pfizer Investigational Site
      • San Diego, California, United States
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • Pfizer Investigational Site
    • Florida
      • Pembroke Pines, Florida, United States
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Pfizer Investigational Site
    • Maine
      • Portland, Maine, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Pfizer Investigational Site
    • Minnesota
      • Albert Lea, Minnesota, United States
        • Pfizer Investigational Site
      • Rochester, Minnesota, United States
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States
        • Pfizer Investigational Site
      • Rochester, New York, United States
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

June 4, 2007

Last Update Submitted That Met QC Criteria

June 1, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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