Smoking Cessation
Conditions
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.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Continuous abstinence Weeks 9-52 | — |
| Brief Questionnaire of Smoking Urges | — |
| Smoking Effects Inventory | — |
| Change from baseline in bodyweight | — |
| Minnesota Nicotine Withdrawal Scale | — |
Countries
United States
Outcome results
None listed