This trial is active, not recruiting.

Conditions smoking cessation, smoking, habits
Treatments varenicline, nicotine cutaneous patch 15mg/16h, nicotine cutaneous patch 10mg/16h, placebo cutaneous patch
Phase phase 2/phase 3
Sponsor Tuula Toljamo
Collaborator University of Oulu
Start date May 2012
End date December 2015
Trial size 300 participants
Trial identifier NCT01531049, EETTMK:99/2011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch
varenicline Champix
days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
Intervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h
nicotine cutaneous patch 15mg/16h Nicorette
One patch for 16hours/day and duration of 8 weeks.
Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h
nicotine cutaneous patch 10mg/16h Nicorette
One patch 16hours/day and duration of 8 weeks
placebo cutaneous patch Leukomed T
No active medication.O ne patch 16hours and duration for 8 weeks
(Placebo Comparator)
No active medication.One transdermal patch/16 h.Total duration was 8 weeks.
nicotine cutaneous patch 10mg/16h Nicorette
One patch 16hours/day and duration of 8 weeks
placebo cutaneous patch Leukomed T
No active medication.O ne patch 16hours and duration for 8 weeks

Primary Outcomes

The abstinence rate
time frame: 3 months follow-up

Secondary Outcomes

The saliva cotinine verified abstinence rate
time frame: 3 months follow-up
The abstinence rate
time frame: 1, 6 and 12 months follow-up

Eligibility Criteria

Male or female participants from 18 years up to 26 years old.

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

Additional Information

Official title Smoking Cessation in Young Adults in Northern Finland
Principal investigator Pentti Nieminen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Oulu.