Smoking Habits and Smoking Cessation in Young Adults

NCT ID: NCT01531049

Last Updated: 2017-06-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-09-02

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.

Conditions

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Smoking Cessation Smoking Habits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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

Group Type EXPERIMENTAL

varenicline

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Nicotine cutaneous patch 15mg/16h

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Nicotine cutaneous patch 10mg/16h

Intervention Type DRUG

One patch 16hours/day and duration of 8 weeks

Placebo cutaneous patch

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

Nicotine cutaneous patch 10mg/16h

Intervention Type DRUG

One patch 16hours/day and duration of 8 weeks

Placebo cutaneous patch

Intervention Type OTHER

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

Intervention Type DRUG

Nicotine cutaneous patch 15mg/16h

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

Intervention Type DRUG

Nicotine cutaneous patch 10mg/16h

One patch 16hours/day and duration of 8 weeks

Intervention Type DRUG

Placebo cutaneous patch

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

Intervention Type OTHER

Other Intervention Names

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Champix Nicorette Nicorette Leukomed T

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oulu

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Tuula Toljamo

OTHER

Sponsor Role lead

Responsible Party

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Tuula Toljamo

Chief Chest Physician, Lapland Central Hospital,Rovaniemi,Finland

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Finland

Other Identifiers

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EETTMK:99/2011

Identifier Type: -

Identifier Source: org_study_id

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