Smoking Habits and Smoking Cessation in Young Adults

Smoking Cessation Clinical Trial

Official title:

Smoking Cessation in Young Adults in Northern Finland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531049
• Other study ID #: EETTMK:99/2011
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 3, 2012
• Last updated: June 2, 2017
• Start date: May 2012
• Est. completion date: September 2, 2016

Study information

• Verified date: June 2017
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Habits
• Smoking
• Smoking Cessation

Intervention

Drug:
• varenicline
days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
• Nicotine cutaneous patch 15mg/16h
One patch for 16hours/day and duration of 8 weeks.
• Nicotine cutaneous patch 10mg/16h
One patch 16hours/day and duration of 8 weeks

Other:
• Placebo cutaneous patch
No active medication.O ne patch 16hours and duration for 8 weeks

Locations

Country	Name	City	State
Finland	Lapland Central Hospital, Lapland Hospital District	Rovaniemi

Sponsors (3)

Lead Sponsor	Collaborator
Tuula Toljamo	Helsinki University, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The abstinence rate		3 months follow-up
Secondary	The saliva cotinine verified abstinence rate		3 months follow-up
Secondary	The abstinence rate		1, 6 and 12 months follow-up