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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141206

Purpose

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 III

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:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

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:	May 2003
Study Completion Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141206

Locations

United States, Arizona
Pfizer Investigational Site
Tucson, Arizona, United States
United States, California
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
Riverside, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Upland, California, United States
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, 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, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States
Pfizer Investigational Site
Great Neck, New York, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States
United States, West Virginia
Pfizer Investigational Site
Morgantown, West Virginia, United States

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

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

Gonzales D, Jorenby DE, Brandon TH, Arteaga C, Lee TC. Immediate versus delayed quitting and rates of relapse among smokers treated successfully with varenicline, bupropion SR or placebo. Addiction. 2010 Nov;105(11):2002-13. Epub 2010 Sep 1.

Hays JT, Leischow SJ, Lawrence D, Lee TC. Adherence to treatment for tobacco dependence: association with smoking abstinence and predictors of adherence. Nicotine Tob Res. 2010 Jun;12(6):574-81. Epub 2010 May 10.

Nides M, Glover ED, Reus VI, Christen AG, Make BJ, Billing CB, Williams KE. Varenicline Versus Bupropion SR or Placebo for Smoking Cessation: A Pooled Analysis. Am J Health Behav. 2008 Nov-Dec;32(6):664-75.

West R, Baker CL, Cappelleri JC, Bushmakin AG. Effect of varenicline and bupropion SR on craving, nicotine withdrawal symptoms, and rewarding effects of smoking during a quit attempt. Psychopharmacology (Berl). 2008 Apr;197(3):371-7. Epub 2007 Dec 15.

Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55.

ClinicalTrials.gov Identifier:	NCT00141206 History of Changes
Other Study ID Numbers:	A3051028
Study First Received:	August 30, 2005
Last Updated:	June 1, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists

Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 07, 2012