Smoking Habits and Smoking Cessation in Young Adults
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.
Drug: Nicotine cutaneous patch
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Smoking Cessation in Young Adults in Northern Finland|
- The continuous abstinence rate as the primary end point [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
- The urine cotinine testing [ Time Frame: 1year ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch).Participants are allowed to use 2mg or 4mg nicotine gum as needed, and the nicotine dependence is assessed by Heaviness of Smoking Index (HSI) with two questions during baseline visit. The participants use study medication during 12 weeks.
days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
Placebo Comparator: Nicotine cutaneous patch
A control group (motivational interview and nicotine patch with placebo pill. Participants are allowed to use 2mg or 4mg nicotine gum as needed, and the nicotine dependence is assessed by Heaviness of Smoking Index (HSI) with two questions during baseline visit. The participants use study medication during 12 weeks.
Drug: Nicotine cutaneous patch
Nicotinell patches 21mg/24hours , 14mg/24hours or 7 mg/24 are chosen according to heaviness of nicotine addiction
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531049
|Contact: Tuula Toljamo, MD||+358 16 328 firstname.lastname@example.org|
|Lapland Central Hospital, Lapland Hospital District||Recruiting|
|Rovaniemi, Finland, 96400|
|Principal Investigator: Tuula Toljamo, MD|
|Principal Investigator:||Pentti Nieminen, PhD||Medical Informatics and Statistics Research Group, University of Oulu|