Harm Reduction, Smokeless Tobacco, Smoking Cessation
Conditions
Keywords
smokeless tobacco, Nicotine, Cadmium, lead, Tobacco Specific Nitrosamines
Brief summary
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.
Detailed description
Comparisons: A= General Portion 1 g portion snus containing approximately 8 mg nicotine per portion. B= Catch Licorice Portion 1 g portion snus containing approximately 8 mg nicotine per portion. C= Catch Licorice Portion Mini 0.5 g portion snus containing approximately 4 mg nicotine per portion. D= Catch Dry Licorice Portion Mini 0.3 g portion snus containing approximately 4 mg nicotine per portion. Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.
Interventions
PROCEDUREBuccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Sponsors
Swedish Match AB
Contract Research Organization el AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-vivo extraction of cadmium | 30 minutes' use | Extracted amount = mean of 10 unused sachets - residual amount |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-vivo extraction of nicotine | 30 minutes' use | Extracted amount = mean of 10 unused sachets - residual amount in one used sachet |
| in-vivo extraction of tobacco specific nitrosamines (TSNAs) | — | Extracted amount = mean of 10 unused sachets - residual amount in used sachet |
| In-vivo extraction of lead | 30 minutes' use | Extracted amount = mean of 10 unused sachets - residual amount in one used sachet |
Countries
Sweden
Outcome results
None listed