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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
32
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
CROel AB
Helsingborg, Sweden
In-vivo extraction of cadmium
Extracted amount = mean of 10 unused sachets - residual amount
Time frame: 30 minutes' use
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
Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
Time frame: 30 minutes' use
In-vivo extraction of nicotine
Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
Time frame: 30 minutes' use
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