Varenicline for long-term nicotine replacement therapy (NRT) usersA double blind, placebo controlled trial - Long-term NRT:varenicline
- Conditions
- ong-term dependence of nicotine substitution products (gum, inhaler, sublingual, spay)
- Registration Number
- EUCTR2008-006426-34-DK
- Lead Sponsor
- Pulmonary dept. Gentofte Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Long-term, daily NRT users (except nicotine patch) (>11 months) ex-smokers that is willing to try to stop the use of NRT and adhere to this protocol.
More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day
Or more than 3 inhaler cylinders per day
Or more than 10 puffs of nasal spray per day.
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
Smokers
Pregnant and lactating women
Used varenicline before
Not able to cooperate
Other significant diseases that might influence the trial (such as moderate –severe cardiac disease, lung cancer,)
Age <18 years
CO in expired air >7 ppm
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method