Smoking Habits and Smoking Cessation in Young Adults

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and effectiveness of varenicline and nicotine patch combined with motivational interview technique in smoking cessation of young adults over 12 months follow-up.

Detailed Description
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Most teenage smokers are still smoking when they become adults confirming that stopping of smoking at young age is difficult although majority of young smokers want to quit. Young smokers experience many relapses partly due to the lack of appropriate and available cessation services. The discomfort experienced during cessation attempts is likely to be negatively associated with cessation success. Quitting of smoking is by the far most important procedure in preventing COPD progression. In Finland, 18-35% of young adults smoke, the variability being associated at least with socioeconomic background, education and geographical area. Our recent studies on male military draftees have shown that smoking is much more frequent in Northern than Southern Finland. However young men want to quit and accept new smoking restrictions. Very few studies are available on quitting attempts or counselling, pharmacotherapy and/or their combinations in young adults who want to quit.

Official Title
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Smoking Cessation in Young Adults in Northern Finland

Conditions
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Smoking Cessation, Smoking, Habits

Intervention / Treatment
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* Drug: varenicline
* Drug: Nicotine cutaneous patch 15mg/16h
* Drug: Nicotine cutaneous patch 10mg/16h
* Other: Placebo cutaneous patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy daily smokers 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: any chronic disease with daily medication known allergy to study medications(varenicline, nicotine patch,nicotine gum) any substance and/or alcohol abuse drop-outs are counted as current smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline<br>A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch | Drug: varenicline<br>* days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day<br>* Other names: Champix;|
| Experimental: Nicotine cutaneous patch 15mg<br>Intervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h | Drug: Nicotine cutaneous patch 15mg/16h<br>* One patch for 16hours/day and duration of 8 weeks.<br>* Other names: Nicorette;|
| Experimental: Nicotine cutaneous patch 10mg<br>Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h | Drug: Nicotine cutaneous patch 10mg/16h<br>* One patch 16hours/day and duration of 8 weeks<br>* Other names: Nicorette;Other: Placebo cutaneous patch<br>* No active medication.O ne patch 16hours and duration for 8 weeks<br>* Other names: Leukomed T;|
| Placebo Comparator: Placebo cutaneous patch<br>No active medication.One transdermal patch/16 h.Total duration was 8 weeks. | Drug: Nicotine cutaneous patch 10mg/16h<br>* One patch 16hours/day and duration of 8 weeks<br>* Other names: Nicorette;Other: Placebo cutaneous patch<br>* No active medication.O ne patch 16hours and duration for 8 weeks<br>* Other names: Leukomed T;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The abstinence rate |  | 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The saliva cotinine verified abstinence rate |  | 3 months follow-up | 
| The abstinence rate |  | 1, 6 and 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, young adults, motivational counselling, smoking, nicotine replacement therapy, therapy