- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00265460
Smoking Cessation in Groups and With Tobacco Pastils
September 14, 2009 updated by: University Hospital, Gentofte, Copenhagen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
240
Phase
- Phase 2
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
-
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Hellerup
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Copenhagen, Hellerup, Denmark, 2900
- Dept. pulmonary medicine Y, Gentofte University Hospital
-
-
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
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Continuous Smoking cessation quit rate after 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
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Side effects from tested tobacco product
|
Intake of nicotine and thiocyanate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Philip Tønnesen, M.D., Ph.D., Chair dept. pulm. medicine, Gentofte Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2005
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
December 13, 2005
First Submitted That Met QC Criteria
December 13, 2005
First Posted (Estimate)
December 14, 2005
Study Record Updates
Last Update Posted (Estimate)
September 15, 2009
Last Update Submitted That Met QC Criteria
September 14, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tonga.2005.00.
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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