Smoking Cessation Clinical Trial
Official 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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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