Smoking Habits and Smoking Cessation in Young Adults

June 2, 2017 updated by: Tuula Toljamo

Smoking Cessation in Young Adults in Northern Finland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Rovaniemi, Finland, 96400
        • Lapland Central Hospital, Lapland Hospital District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varenicline
A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch
Drug: varenicline
days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
Other Names:
  • Champix
Experimental: Nicotine cutaneous patch 15mg
Intervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h
Drug: Nicotine cutaneous patch 15mg/16h
One patch for 16hours/day and duration of 8 weeks.
Other Names:
  • Nicorette
Experimental: Nicotine cutaneous patch 10mg
Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h
Drug: Nicotine cutaneous patch 10mg/16h
One patch 16hours/day and duration of 8 weeks
Other Names:
  • Nicorette
Other: Placebo cutaneous patch
No active medication.O ne patch 16hours and duration for 8 weeks
Other Names:
  • Leukomed T
Placebo Comparator: Placebo cutaneous patch
No active medication.One transdermal patch/16 h.Total duration was 8 weeks.
Drug: Nicotine cutaneous patch 10mg/16h
One patch 16hours/day and duration of 8 weeks
Other Names:
  • Nicorette
Other: Placebo cutaneous patch
No active medication.O ne patch 16hours and duration for 8 weeks
Other Names:
  • Leukomed T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The abstinence rate
Time Frame: 3 months follow-up
3 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
The saliva cotinine verified abstinence rate
Time Frame: 3 months follow-up
3 months follow-up
The abstinence rate
Time Frame: 1, 6 and 12 months follow-up
1, 6 and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuula Toljamo

Collaborators

University of Helsinki
University of Oulu

Investigators

  • Principal Investigator: Pentti Nieminen, PhD, Medical Informatics and Statistics Research Group, University of Oulu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

September 2, 2016

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EETTMK:99/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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