Smoking Cessation
Conditions
Brief summary
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch 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 15 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 for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52 | — |
| 4-week Point Prevalence of abstinence at Week 52 | — |
| Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52 | — |
| Minnesota Nicotine Withdrawal Scale | — |
| Smoking Effects Inventory | — |
| Long-Term Quit Rate at Weeks 24 and 52 | — |
Countries
Belgium, France, Netherlands, United Kingdom, United States
Outcome results
None listed