Smoking Habits and Smoking Cessation in Young Adults

Sponsor

Tuula Toljamo (Other)

Overall Status

Completed

CT.gov ID

NCT01531049

Collaborator

University of Oulu (Other), University of Helsinki (Other)

300

Enrollment

Location

Arms

52.1

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation Smoking Habits	Drug: varenicline Drug: Nicotine cutaneous patch 15mg/16h Drug: Nicotine cutaneous patch 10mg/16h Other: Placebo cutaneous patch	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Smoking Cessation in Young Adults in Northern Finland

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Sep 2, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The abstinence rate [3 months follow-up]

Secondary Outcome Measures

The saliva cotinine verified abstinence rate [3 months follow-up]
The abstinence rate [1, 6 and 12 months follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 26 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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