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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: August 30, 2005
Last updated: September 3, 2010
Last verified: September 2010
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 for smoking cessation.

Condition Intervention Phase
Smoking Cessation
Drug: varenicline
Phase 3

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, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation

Resource links provided by NLM:

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 rate weeks 9-24
  • Long-term Quit Rate at week 24
  • 7 day point prevalence week 12 and 24
  • Results of Minnesota Nicotine Withdrawal Scale
  • Brief Questionnaire of Smoking Urges
  • Smoking Effects Inventory

Enrollment: 250
Study Start Date: February 2005
Study Completion Date: January 2006

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

  • Subjects who have used bupropion, Zyban, or Wellbutrin previously.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00141167

Korea, Republic of
Pfizer Investigational Site
Anyang-Si, Gyeonggi-do, Korea, Republic of, 431-070
Pfizer Investigational Site
Daegu-si, Korea, Republic of, 700-712
Pfizer Investigational Site
Seoul, Korea, Republic of, 100-032
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Kweishan, Taoyuan County, Taiwan, 333
Pfizer Investigational Site
Hualien, Taiwan, 970
Pfizer Investigational Site
Kaohsiung, Taiwan, 813
Pfizer Investigational Site
Taichung, Taiwan, 40705
Pfizer Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00141167     History of Changes
Obsolete Identifiers: NCT00155298
Other Study ID Numbers: A3051045 
Study First Received: August 30, 2005
Last Updated: September 3, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 24, 2016