Smoking CessationPhase 2/3NCT01531049
Smoking Habits and Smoking Cessation in Young Adults
A Phase 2/3 study testing varenicline, Nicotine cutaneous patch 15mg/16h and Nicotine cutaneous patch 10mg/16h in people with Smoking Cessation and Smoking, run by Tuula Toljamo at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Habits
- What is being tested?
- varenicline, Nicotine cutaneous patch 15mg/16h and Nicotine cutaneous patch 10mg/16h
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- May 2012to 2 Sep 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Lapland Central Hospital, Lapland Hospital District
Rovaniemi, 96400
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Smoking, Habits
- Being tested
- varenicline, Nicotine cutaneous patch 15mg/16h, Nicotine cutaneous patch 10mg/16h, Placebo cutaneous patch
- Keywords
- smoking cessation, young adults, motivational counselling, smoking, nicotine replacement therapy, therapy
- Medical subject headings
- Smoking Cessation, Smoking, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Champix
days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
Nicotine cutaneous patch 15mg/16hDrug
Also called Nicorette
One patch for 16hours/day and duration of 8 weeks.
Nicotine cutaneous patch 10mg/16hDrug
Also called Nicorette
One patch 16hours/day and duration of 8 weeks
Placebo cutaneous patchOther
Also called Leukomed T
No active medication.O ne patch 16hours and duration for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | A varenicline treatment group (with motivational interview technique combined with varenicline and placebo transdermal patch). Intervention with Nicorette 15mg /16 h patch Receives: Drug: varenicline |
| Nicotine cutaneous patch 15mg | Experimental | Intervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h Receives: Drug: Nicotine cutaneous patch 15mg/16h |
| Nicotine cutaneous patch 10mg | Experimental | Intervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h Receives: Drug: Nicotine cutaneous patch 10mg/16h; Other: Placebo cutaneous patch |
| Placebo cutaneous patch | Placebo comparator | No active medication.One transdermal patch/16 h.Total duration was 8 weeks. Receives: Drug: Nicotine cutaneous patch 10mg/16h; Other: Placebo cutaneous patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The abstinence rate
Measured: 3 months follow-up
Secondary outcomes (2)
The saliva cotinine verified abstinence rate
Measured: 3 months follow-up
The abstinence rate
Measured: 1, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startMay 2012
- Primary completion31 Dec 2015
- Study completion2 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuula Toljamo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, University of Helsinki
- Responsible party
- Sponsor-investigator, Tuula Toljamo, University of Oulu
- Investigators
- Pentti Nieminen, PhD, Principal investigator, Medical Informatics and Statistics Research Group, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531049
- Sponsor's protocol ID
- EETTMK:99/2011
- Status last verified
- Jun 2017
- First submitted
- 3 Feb 2012
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation in Young Adults in Northern Finland
- ClinicalTrials.gov ID
- NCT01531049
- Acronym / sponsor ID
- EETTMK:99/2011
- Conditions
- Smoking Cessation, Smoking, Habits
- Keywords
- smoking cessation, young adults, motivational counselling, smoking, nicotine replacement therapy, therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tuula ToljamoUniversity, hospital or other
- Collaborators
- University of Oulu, University of Helsinki
- Study start
- May 2012
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 2 Sep 2016 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: vareniclineA 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 | Experimental | Drug: Nicotine cutaneous patch 15mg/16hIntervention with Varenicline for 12 weeks. Nicotine cutaneous patch 15mg/16h |
| Nicotine cutaneous patch 10mg | Experimental | Drug: Nicotine cutaneous patch 10mg/16h, Other: Placebo cutaneous patchIntervention with Placebo transdermal patch for 8 weeks. Nicotine cutaneous patch 10mg/16h |
| Placebo cutaneous patch | Placebo comparator | Drug: Nicotine cutaneous patch 10mg/16h, Other: Placebo cutaneous patchNo active medication.One transdermal patch/16 h.Total duration was 8 weeks. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vareniclineAlso: Champixdays 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day | Drug | Varenicline |
| Nicotine cutaneous patch 15mg/16hAlso: NicoretteOne patch for 16hours/day and duration of 8 weeks. | Drug | Nicotine cutaneous patch 15mg |
| Nicotine cutaneous patch 10mg/16hAlso: NicoretteOne patch 16hours/day and duration of 8 weeks | Drug | Nicotine cutaneous patch 10mg, Placebo cutaneous patch |
| Placebo cutaneous patchAlso: Leukomed TNo active medication.O ne patch 16hours and duration for 8 weeks | Other | Nicotine cutaneous patch 10mg, Placebo cutaneous patch |
Primary outcome
The abstinence rate
Time frame: 3 months follow-up
2 secondary outcomes
The saliva cotinine verified abstinence rate
Time frame: 3 months follow-up
The abstinence rate
Time frame: 1, 6 and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pentti Nieminen, PhD principal investigator
Medical Informatics and Statistics Research Group, University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing varenicline, Nicotine cutaneous patch 15mg/16h and Nicotine cutaneous patch 10mg/16h in people with Smoking Cessation and Smoking, run by Tuula Toljamo at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The abstinence rate (time frame: 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.