Smoking Habits and Smoking Cessation in Young Adults

Tuula Toljamo

Status and phase

Completed

Phase 3

Phase 2

Conditions

Habits

Smoking

Smoking Cessation

Treatments

Other: Placebo cutaneous patch

Drug: varenicline

Drug: Nicotine cutaneous patch 10mg/16h

Drug: Nicotine cutaneous patch 15mg/16h

Study type

Interventional

Funder types

Other

Identifiers

NCT01531049

EETTMK:99/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

18 to 26 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 4 patient groups, including a placebo group

Varenicline

Experimental group

Description:

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

Treatment:

Drug: varenicline

Nicotine cutaneous patch 15mg

Experimental group

Description:

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

Treatment:

Drug: Nicotine cutaneous patch 15mg/16h

Nicotine cutaneous patch 10mg

Experimental group

Description:

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