Smoking Habits and Smoking Cessation in Young Adults

Phase 2

Completed

• Conditions: Smoking Cessation; Smoking; Habits
• Interventions: Drug: Nicotine cutaneous patch 10mg/16h; Drug: Nicotine cutaneous patch 15mg/16h; Drug: varenicline; Other: Placebo cutaneous patch

• Registration Number: NCT01531049
• Lead Sponsor: Tuula Toljamo

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.

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 Timeline

• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2012-05
• Primary Completion: 2015-12-31
• Study Completion: 2016-09-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-02
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo cutaneous patch	Nicotine cutaneous patch 10mg/16h	No active medication.One transdermal patch/16 h.Total duration was 8 weeks.
Nicotine cutaneous patch 15mg	Nicotine cutaneous patch 15mg/16h	Intervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h
Placebo cutaneous patch	Placebo cutaneous patch	No active medication.One transdermal patch/16 h.Total duration was 8 weeks.
Nicotine cutaneous patch 10mg	Placebo cutaneous patch	Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h
Nicotine cutaneous patch 10mg	Nicotine cutaneous patch 10mg/16h	Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h
Varenicline	varenicline	A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch

Primary Outcome Measures

Name	Time	Method
The abstinence rate	3 months follow-up

Secondary Outcome Measures

Name	Time	Method
The saliva cotinine verified abstinence rate	3 months follow-up
The abstinence rate	1, 6 and 12 months follow-up

Trial Locations

Locations (1)

Lapland Central Hospital, Lapland Hospital District; 🇫🇮 Rovaniemi, Finland