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| Name | Class |
|---|---|
| University of Oulu | OTHER |
| University of Helsinki | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline | Experimental | A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch |
|
| Nicotine cutaneous patch 15mg | Experimental | Intervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h |
|
| Nicotine cutaneous patch 10mg | Experimental | Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h |
|
| Placebo cutaneous patch | Placebo Comparator | No active medication.One transdermal patch/16 h.Total duration was 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day |
|
| Measure | Description | Time Frame |
|---|---|---|
| The abstinence rate | 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The saliva cotinine verified abstinence rate | 3 months follow-up | |
| The abstinence rate | 1, 6 and 12 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pentti Nieminen, PhD | Medical Informatics and Statistics Research Group, University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lapland Central Hospital, Lapland Hospital District | Rovaniemi | 96400 | Finland |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D006184 | Habits |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Nicotine cutaneous patch 15mg/16h | Drug | One patch for 16hours/day and duration of 8 weeks. |
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| Nicotine cutaneous patch 10mg/16h | Drug | One patch 16hours/day and duration of 8 weeks |
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| Placebo cutaneous patch | Other | No active medication.O ne patch 16hours and duration for 8 weeks |
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|
| D011810 | Quinoxalines |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |