Smoking Cessation
Conditions
Brief summary
The purpose of the study is to measure the safety and efficacy of three doses of varenicline 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 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have smoked on average of at least ten cigarettes per day during the past year * Subjects must have no period of abstinence greater than three months in the past year
Exclusion criteria
* Subjects with any history of cardiovascular disease * Myocardial infarction * Significant arrhythmias * Poorly controlled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52 | — |
| 7-day Point Prevalence of abstinence Week 52 | — |
| Number of cigarettes smoked per day | — |
| Fixed window 4-week CQR, Weeks 3-6, 4-7 | — |
| Smoking Effects Inventory | — |
| Brief Questionnaire of Smoking Urge | — |
| Minnesota Nicotine Withdrawal Scale | — |
Countries
United States
Outcome results
None listed