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OpenTrials
Completed

NCT Number: NCT01531049

Smoking Habits and Smoking Cessation in Young Adults

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.

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Key information

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Lapland Central Hospital, Lapland Hospital District

Rovaniemi, 96400, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day

Other names: Champix

Nicotine cutaneous patch 15mg/16h

Drug

One patch for 16hours/day and duration of 8 weeks.

Other names: Nicorette

Nicotine cutaneous patch 10mg/16h

Drug

One patch 16hours/day and duration of 8 weeks

Other names: Nicorette

Placebo cutaneous patch

Other

No active medication.O ne patch 16hours and duration for 8 weeks

Other names: Leukomed T

Primary outcomes

  1. The abstinence rate

    Time frame: 3 months follow-up

Secondary outcomes

  1. The saliva cotinine verified abstinence rate

    Time frame: 3 months follow-up

  2. The abstinence rate

    Time frame: 1, 6 and 12 months follow-up

Sponsors and collaborators

Lead sponsor

Tuula Toljamo

Other

Collaborators

  • University of Helsinki
  • University of Oulu

Registry information

Official study title

Smoking Cessation in Young Adults in Northern Finland

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 10, 2012
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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