A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
Phase 3
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00143364
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1005
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Milwaukee, Wisconsin, United States