A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation
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
1 other identifier
interventional
250
2 countries
10
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 for smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2005
Shorter than P25 for phase_3
10 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
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedSeptember 6, 2010
September 1, 2010
August 30, 2005
September 3, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
Secondary Outcomes (6)
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
- +1 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 (10)
Pfizer Investigational Site
Anyang-si, Gyeonggi-do, 431-070, South Korea
Pfizer Investigational Site
Daegu, 700-712, South Korea
Pfizer Investigational Site
Seoul, 100-032, South Korea
Pfizer Investigational Site
Seoul, 110-744, South Korea
Pfizer Investigational Site
Seoul, 138-736, South Korea
Pfizer Investigational Site
Kweishan, Taoyuan County, 333, Taiwan
Pfizer Investigational Site
Hualien City, 970, Taiwan
Pfizer Investigational Site
Kaohsiung City, 813, Taiwan
Pfizer Investigational Site
Taichung, 40705, Taiwan
Pfizer Investigational Site
Taipei, 100, Taiwan
Related Publications (2)
Livingstone-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: 37142273DERIVEDTsai ST, Cho HJ, Cheng HS, Kim CH, Hsueh KC, Billing CB Jr, Williams KE. A randomized, placebo-controlled trial of varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers. Clin Ther. 2007 Jun;29(6):1027-39. doi: 10.1016/j.clinthera.2007.06.011.
PMID: 17692719DERIVED
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 30, 2005
First Posted
September 1, 2005
Study Start
February 1, 2005
Study Completion
January 1, 2006
Last Updated
September 6, 2010
Record last verified: 2010-09