Smoking Cessation Clinical Trial
— SMWS03Official title:
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 2005 |
Est. primary completion date | August 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Non-smokers, 18 to 50 years of age. - Habitual use of > 7 portions snus daily since minimum 1 year. - Healthy according to the health declaration and interview. - Written informed consent given. Exclusion Criteria: - Concurrent participation in another clinical trial. - History of allergy. - History of allergy. |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Sweden | CROel AB | Helsingborg |
Lead Sponsor | Collaborator |
---|---|
Contract Research Organization el AB | Swedish Match AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-vivo extraction of cadmium | Extracted amount = mean of 10 unused sachets - residual amount | 30 minutes' use | Yes |
Secondary | in-vivo extraction of tobacco specific nitrosamines (TSNAs) | Extracted amount = mean of 10 unused sachets - residual amount in used sachet | 30 minutes' use | Yes |
Secondary | In-vivo extraction of lead | Extracted amount = mean of 10 unused sachets - residual amount in one used sachet | 30 minutes' use | Yes |
Secondary | In-vivo extraction of nicotine | Extracted amount = mean of 10 unused sachets - residual amount in one used sachet | 30 minutes' use | Yes |
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