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
- NCT00141206
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which varenicline modulates nicotinic acetylcholine receptors to aid smoking cessation?
How does varenicline's efficacy in NCT00141206 compare to Zyban and placebo in terms of long-term abstinence rates and relapse prevention?
Which biomarkers or genetic factors could predict patient response to varenicline versus Zyban in smoking cessation trials?
What are the most common adverse events reported in phase 3 varenicline trials like NCT00141206 and how are they managed clinically?
How do varenicline's pharmacological properties compare to other nicotinic receptor partial agonists in smoking cessation therapies?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Morgantown, West Virginia, United States
Pfizer Investigational Site🇺🇸Morgantown, West Virginia, United States