A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation
Phase 3
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00141167
- 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 for smoking cessation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Taipei, Taiwan