Smoking Habits and Smoking Cessation in Young Adults
Smoking Cessation in Young Adults in Northern Finland
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2016
CompletedJune 5, 2017
June 1, 2017
3.7 years
February 3, 2012
June 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The abstinence rate
3 months follow-up
Secondary Outcomes (2)
The saliva cotinine verified abstinence rate
3 months follow-up
The abstinence rate
1, 6 and 12 months follow-up
Study Arms (4)
Varenicline
EXPERIMENTALA varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch
Nicotine cutaneous patch 15mg
EXPERIMENTALIntervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h
Nicotine cutaneous patch 10mg
EXPERIMENTALIntervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h
Placebo cutaneous patch
PLACEBO COMPARATORNo active medication.One transdermal patch/16 h.Total duration was 8 weeks.
Interventions
days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
One patch for 16hours/day and duration of 8 weeks.
One patch 16hours/day and duration of 8 weeks
No active medication.O ne patch 16hours and duration for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tuula Toljamolead
- University of Oulucollaborator
- University of Helsinkicollaborator
Study Sites (1)
Lapland Central Hospital, Lapland Hospital District
Rovaniemi, 96400, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pentti Nieminen, PhD
Medical Informatics and Statistics Research Group, University of Oulu
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Chest Physician, Lapland Central Hospital,Rovaniemi,Finland
Study Record Dates
First Submitted
February 3, 2012
First Posted
February 10, 2012
Study Start
May 1, 2012
Primary Completion
December 31, 2015
Study Completion
September 2, 2016
Last Updated
June 5, 2017
Record last verified: 2017-06