Smokers smoking at least 10 cigarettes/day in the past year
Conditions
Brief summary
Continuous smoking abstinence rate during the last 4 weeks of a treatment period of 3 months.
Detailed description
The assessment criterion of the safety will be the comparison of serious adverse events and non-serious adverse events, Point prevalence abstinence: self-report of 7-day smoking abstinence at each visit associated with expired air CO ≤ 8 ppm., Time to relapse to smoking after the predefined target quit day, Change in cigarettes/day consumption, Change in craving for tobacco, Change in withdrawal symptoms
Interventions
DRUGCHAMPIX 0.5 mg film-coated tablets
DRUGPlacebo CHAMPIX ® 0.5mg Comprimé pelliculé
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous smoking abstinence rate during the last 4 weeks of a treatment period of 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment criterion of the safety will be the comparison of serious adverse events and non-serious adverse events, Point prevalence abstinence: self-report of 7-day smoking abstinence at each visit associated with expired air CO ≤ 8 ppm., Time to relapse to smoking after the predefined target quit day, Change in cigarettes/day consumption, Change in craving for tobacco, Change in withdrawal symptoms | — |
Countries
France
Outcome results
None listed