Status:
UNKNOWN
Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
Pfizer
Conditions:
Tobacco Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop? Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.
Detailed Description
100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT. Assessments consist of carbon monoxide in e...
Eligibility Criteria
Inclusion
- Long-term, daily NRT users (except nicotine patch) (\>11 months) ex-smokers that are 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.
Exclusion
- Age \< 18 years,
- CO 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,) in expired air \> 7 ppm.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00977249
Start Date
September 1 2009
End Date
December 1 2011
Last Update
September 15 2009
Active Locations (1)
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1
Gentofte Hospital
Copenhagen, Hellerup, Denmark, 2900