Smoking Cessation
Conditions
Brief summary
The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.
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 with clinically significant cardiovascular disease in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous abstinence Weeks 13 -24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous abstinence Weeks 13-52 | — |
| Long term quit rate at Week 52 | — |
| 7-day Point Prevalence of abstinence at Weeks 24, 52 | — |
| 4-week Point Prevalence of abstinence at Week 52 | — |
| Time to first cigarette post randomization | — |
Countries
Canada, Czechia, Denmark, Norway, Sweden, United Kingdom, United States
Outcome results
None listed