Smoking: Subjects must be daily smokers MedDRA version: 12.0 Level: PT Classification code 10053325 Term: Smoking cessation therapy
Conditions
Interventions
Trade Name: CHAMPIX
Product Name: Varenicline
Product Code: N07BA03
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VARENICLINE
CAS Number: 249296-44-4
Concentration unit: mg milligram(s)
Sponsors
Maastricht University - CAPHRI School for Public Health and Primary Care
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Daily smokers 18 years of age or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contra-indications for the use of varenicline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does a 12-week combination therapy of open label varenicline and individual counselling increase the carbon monoxide validated prolonged smoking cessation rate from week 9 through 26, compared with 12 weeks single open label varenicline in adult daily cigarette smokers?;Secondary Objective: What are the short-term health and economic effects of smoking cessation? What is the difference in compliance with the use of varenicline in group varenicline and counselling compared to varenicline alone?;Primary end point(s): Prolonged absinence of smoking from week 9 through 26 confirmed by self-reported smoking and validated by exhaled carbon monoxide (CO). | — |
Countries
Netherlands
Outcome results
None listed