CClinicalTrials.gg
CompletedNCT00141206Updated Jun 4, 2007

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

A Phase 3 interventional study of varenicline (CP-526,555) in Smoking Cessation, sponsored by Pfizer. Completed at 20 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-06-04.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,005
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Smoking Cessation
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subjects who have used bupropion (Zyban, or Wellbutrin) previously.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,005 participants

Interventions

  • Drugvarenicline (CP-526,555)
06

What researchers measure

Primary outcomes

  1. 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Secondary outcomes

  1. Continuous abstinence Weeks 9-52

  2. Long-term Quit Rate Week 52

  3. Continuous abstinence Weeks 9 -24

  4. 7-day Point Prevalence Abstinence Weeks 12, 24, and 52

  5. 4-week Point Prevalence Abstinence at Week 52

  6. Minnesota Nicotine Withdrawal Scale

  7. Brief Questionnaire of Smoking Urges

  8. Smoking Effects Inventory

  9. Change from baseline in bodyweight

07

Study locations

20 sites
  • Pfizer Investigational Site
    Tucson, Arizona, United States
  • 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
  • Pfizer Investigational Site
    Farmington, Connecticut, United States
  • Pfizer Investigational Site
    Miami, Florida, United States
  • Pfizer Investigational Site
    Atlanta, Georgia, United States
  • Pfizer Investigational Site
    Chicago, Illinois, United States
  • Pfizer Investigational Site
    Lexington, Kentucky, United States
  • Pfizer Investigational Site
    New Orleans, Louisiana, United States
  • Pfizer Investigational Site
    Worcester, Massachusetts, United States
  • Pfizer Investigational Site
    Omaha, Nebraska, United States
  • Pfizer Investigational Site
    Brooklyn, New York, United States
  • Pfizer Investigational Site
    Great Neck, New York, United States
  • Pfizer Investigational Site
    Portland, Oregon, United States
  • Pfizer Investigational Site
    Philadelphia, Pennsylvania, United States
  • Pfizer Investigational Site
    Salt Lake City, Utah, United States
  • Pfizer Investigational Site
    Morgantown, West Virginia, United States
08

References and documents

Publications

  • Hays 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. PubMed 20884658 ↗
  • 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. doi: 10.1111/j.1360-0443.2010.03058.x. Epub 2010 Sep 1. PubMed 20819082 ↗
  • 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. doi: 10.1093/ntr/ntq047. Epub 2010 May 10. PubMed 20457644 ↗
  • Nides 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. PubMed 18442345 ↗
  • 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. doi: 10.1007/s00213-007-1041-3. Epub 2007 Dec 15. PubMed 18084743 ↗
  • 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. doi: 10.1001/jama.296.1.47. PubMed 16820546 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00141206
Lead sponsor
Pfizer
First posted
Sep 1, 2005
Start date
May 2003
Completion
Apr 2005
Last update
Jun 4, 2007

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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