SmokingPhase 2NCT00265460
Smoking Cessation in Groups and With Tobacco Pastils
A Phase 2 study testing Oliwer Twist smokeless tobacco (tobacco) in people with Smoking, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Oliwer Twist smokeless tobacco (tobacco)
- How many people
- 240 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2005to Nov 2006
- Phase
- Phase 2
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smoking > 13 cigarettes/day
- healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)
- motivated for cessation
- motivated to use tobacco pastils
- motivated for group support
Who cannot join
- severe diseases
- psychiatric diseases
- using antipsychotic drugs
- used NRT/bupropion in the last 3 months
- consuming > 6 drinks/day
- pregnant/lactating
- stopped smoking more than 2 days during last 3 months
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. pulmonary medicine Y, Gentofte University Hospital
Copenhagen, Hellerup, 2900
About this study
Official title: Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation
The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.
Read the detailed description
The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.
- Conditions
- Smoking
- Being tested
- Oliwer Twist smokeless tobacco (tobacco)
- Keywords
- smoking cessation,, nicotine,, smokeless tobacco,, cigarettes
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oliwer Twist smokeless tobacco (tobacco)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Smoking cessation quit rate after 6 and 12 months
Secondary outcomes (2)
Side effects from tested tobacco product
Intake of nicotine and thiocyanate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startMar 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Philip Tønnesen, M.D., Ph.D., Study chair, Chair dept. pulm. medicine, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265460
- Sponsor's protocol ID
- Tonga.2005.00.
- Status last verified
- Sep 2009
- First submitted
- 13 Dec 2005
- Last updated
- 15 Sep 2009
- Results posted
- No
Publications
Tonnesen P, Mikkelsen K, Bremann L. Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial. Nicotine Tob Res. 2008 Aug;10(8):1365-72. doi: 10.1080/14622200802238969.
PubMed 18686184
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00265460
- Acronym / sponsor ID
- Tonga.2005.00.
- Conditions
- Smoking
- Keywords
- smoking cessation,, nicotine,, smokeless tobacco,, cigarettes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 14 Dec 2005 (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 trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.
Detailed description
The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- smoking > 13 cigarettes/day
- healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)
- motivated for cessation
- motivated to use tobacco pastils
- motivated for group support
Key exclusion criteria (7 listed)
- severe diseases
- psychiatric diseases
- using antipsychotic drugs
- used NRT/bupropion in the last 3 months
- consuming > 6 drinks/day
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 |
|---|---|---|
| Oliwer Twist smokeless tobacco (tobacco) | Drug | – |
Primary outcome
Continuous Smoking cessation quit rate after 6 and 12 months
2 secondary outcomes
Side effects from tested tobacco product
Intake of nicotine and thiocyanate
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 15 Sep 2009.
- Results publication: PubMed 18686184Tonnesen P, Mikkelsen K, Bremann L. Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial. Nicotine Tob Res. 2008 Aug;10(8):1365-72. doi: 10.1080/14622200802238969.
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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.
Philip Tønnesen, M.D., Ph.D. study chair
Chair dept. pulm. medicine, Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oliwer Twist smokeless tobacco (tobacco) in people with Smoking, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 7 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 15 Sep 2009. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Continuous Smoking cessation quit rate after 6 and 12 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00265460, which also lists 1 linked publication.
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 15 Sep 2009.