Smoking Habits and Smoking Cessation in Young Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Oulu
Sponsor:
Collaborators:
University of Oulu
Helsinki University
Information provided by (Responsible Party):
Tuula Toljamo, University of Oulu
ClinicalTrials.gov Identifier:
NCT01531049
First received: February 3, 2012
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Smoking
Habits
Drug: varenicline
Drug: Nicotine cutaneous patch
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • The continuous abstinence rate as the primary end point [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The urine cotinine testing [ Time Frame: 1year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
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)
Arms Assigned Interventions
Experimental: Varenicline
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.
Drug: varenicline
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531049

Contacts
Contact: Tuula Toljamo, MD +358 16 328 3201 tuula.toljamo@lshp.fi

Locations
Finland
Lapland Central Hospital, Lapland Hospital District Recruiting
Rovaniemi, Finland, 96400
Principal Investigator: Tuula Toljamo, MD         
Sponsors and Collaborators
Tuula Toljamo
University of Oulu
Helsinki University
Investigators
Principal Investigator: Pentti Nieminen, PhD Medical Informatics and Statistics Research Group, University of Oulu
  More Information

No publications provided

Responsible Party: Tuula Toljamo, Chief Chest Physician, Lapland Central Hospital,Rovaniemi,Finland, University of Oulu
ClinicalTrials.gov Identifier: NCT01531049     History of Changes
Other Study ID Numbers: EETTMK:99/2011
Study First Received: February 3, 2012
Last Updated: April 25, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
smoking cessation
young adults
motivational counselling
smoking
nicotine replacement therapy
therapy

Additional relevant MeSH terms:
Varenicline
Nicotine
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014