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临床试验/NCT01531049
NCT01531049已完成2 期

Smoking Cessation in Young Adults in Northern Finland

Tuula Toljamo1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
The abstinence rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Varenicline

Experimental

A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch

干预措施: varenicline (Drug)

Nicotine cutaneous patch 15mg

Experimental

Intervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h

干预措施: Nicotine cutaneous patch 15mg/16h (Drug)

Nicotine cutaneous patch 10mg

Experimental

Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h

干预措施: Nicotine cutaneous patch 10mg/16h (Drug)

Nicotine cutaneous patch 10mg

Experimental

Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h

干预措施: Placebo cutaneous patch (Other)

Placebo cutaneous patch

Placebo Comparator

No active medication.One transdermal patch/16 h.Total duration was 8 weeks.

干预措施: Nicotine cutaneous patch 10mg/16h (Drug)

Placebo cutaneous patch

Placebo Comparator

No active medication.One transdermal patch/16 h.Total duration was 8 weeks.

干预措施: Placebo cutaneous patch (Other)

结局指标

主要结局

The abstinence rate

时间窗: 3 months follow-up

次要结局

  • The saliva cotinine verified abstinence rate(3 months follow-up)
  • The abstinence rate(1, 6 and 12 months follow-up)

研究者

发起方
Tuula Toljamo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tuula Toljamo

Chief Chest Physician, Lapland Central Hospital,Rovaniemi,Finland

University of Oulu

研究点 (1)

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