Helping more smokers to quit by combining varenicline with counselling for smoking cessation. The COVACO randomized controlled trial. - COVACO
- Conditions
- Smoking: Subjects must be daily smokersMedDRA version: 12.0Level: PTClassification code 10053325Term: Smoking cessation therapy
- Registration Number
- EUCTR2009-016446-50-NL
- Lead Sponsor
- Maastricht University - CAPHRI School for Public Health and Primary Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Contra-indications for the use of varenicline
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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?<br>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).<br>
- Secondary Outcome Measures
Name Time Method