A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
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
1 other identifier
interventional
1,005
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2003
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedJune 4, 2007
June 1, 2007
August 31, 2005
June 1, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects who have used bupropion (Zyban or Wellbutrin) previously.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (15)
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Portland, Maine, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Albert Lea, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Providence, Rhode Island, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Related Publications (8)
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PMID: 37230961DERIVEDLivingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVEDHays JT, Croghan IT, Baker CL, Cappelleri JC, Bushmakin AG. Changes in health-related quality of life with smoking cessation treatment. Eur J Public Health. 2012 Apr;22(2):224-9. doi: 10.1093/eurpub/ckq137. Epub 2010 Sep 30.
PMID: 20884658DERIVEDGonzales 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. doi: 10.1111/j.1360-0443.2010.03058.x. Epub 2010 Sep 1.
PMID: 20819082DERIVEDHays 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. doi: 10.1093/ntr/ntq047. Epub 2010 May 10.
PMID: 20457644DERIVEDNides M, Glover ED, Reus VI, Christen AG, Make BJ, Billing CB Jr, 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. doi: 10.5555/ajhb.2008.32.6.664.
PMID: 18442345DERIVEDWest 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. doi: 10.1007/s00213-007-1041-3. Epub 2007 Dec 15.
PMID: 18084743DERIVEDJorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.
PMID: 16820547DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
June 1, 2003
Study Completion
March 1, 2005
Last Updated
June 4, 2007
Record last verified: 2007-06