Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2012-05-31
2016-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Varenicline
A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch
varenicline
days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
Nicotine cutaneous patch 15mg
Intervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h
Nicotine cutaneous patch 15mg/16h
One patch for 16hours/day and duration of 8 weeks.
Nicotine cutaneous patch 10mg
Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h
Nicotine cutaneous patch 10mg/16h
One patch 16hours/day and duration of 8 weeks
Placebo cutaneous patch
No active medication.O ne patch 16hours and duration for 8 weeks
Placebo cutaneous patch
No active medication.One transdermal patch/16 h.Total duration was 8 weeks.
Nicotine cutaneous patch 10mg/16h
One patch 16hours/day and duration of 8 weeks
Placebo cutaneous patch
No active medication.O ne patch 16hours and duration for 8 weeks
Interventions
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varenicline
days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
Nicotine cutaneous patch 15mg/16h
One patch for 16hours/day and duration of 8 weeks.
Nicotine cutaneous patch 10mg/16h
One patch 16hours/day and duration of 8 weeks
Placebo cutaneous patch
No active medication.O ne patch 16hours and duration for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a daily smoker has smoked at least 1cig/day every day during last month and has smoked at least 100 cig ever
* a nonsmoker has smoked less than 50 cig ever,and has not smoked at all during last month
* motivated to quit smoking and ready to 12 months follow-up
* minor allergy or mild asthma without regular medication is allowed
Exclusion Criteria
* known allergy to study medications(varenicline, nicotine patch,nicotine gum)
* any substance and/or alcohol abuse
* drop-outs are counted as current smokers
18 Years
26 Years
ALL
Yes
Sponsors
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University of Oulu
OTHER
University of Helsinki
OTHER
Tuula Toljamo
OTHER
Responsible Party
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Tuula Toljamo
Chief Chest Physician, Lapland Central Hospital,Rovaniemi,Finland
Principal Investigators
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Pentti Nieminen, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical Informatics and Statistics Research Group, University of Oulu
Locations
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Lapland Central Hospital, Lapland Hospital District
Rovaniemi, , Finland
Countries
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Other Identifiers
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EETTMK:99/2011
Identifier Type: -
Identifier Source: org_study_id
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