Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 407 for:    Open Studies | "Smoking"

Smoking Habits and Smoking Cessation in Young Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Oulu
University of Oulu
Helsinki University
Information provided by (Responsible Party):
Tuula Toljamo, University of Oulu Identifier:
First received: February 3, 2012
Last updated: December 17, 2014
Last verified: December 2014

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
Drug: varenicline
Drug: Nicotine cutaneous patch 15mg/16h
Drug: Nicotine cutaneous patch 10mg/16h
Other: Placebo cutaneous patch
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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). 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 Name: 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 Name: 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 Name: Nicorette
Other: Placebo cutaneous patch
No active medication.O ne patch 16hours and duration for 8 weeks
Other Name: 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 Name: Nicorette
Other: Placebo cutaneous patch
No active medication.O ne patch 16hours and duration for 8 weeks
Other Name: Leukomed T

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.


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

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 identifier: NCT01531049

Contact: Tuula Toljamo, MD +358 16 328 3201

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
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 Identifier: NCT01531049     History of Changes
Other Study ID Numbers: EETTMK:99/2011
Study First Received: February 3, 2012
Last Updated: December 17, 2014
Health Authority: Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on March 03, 2015