NCT01249339

In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus

In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Contract Research Organization el AB · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation
• Smokeless Tobacco
• Harm Reduction

Interventions

Type	Name	Description
PROCEDURE	Buccal Administration of nicotine	Oral pouch 1g, single dose. One pouch administered over 30 minutes.
PROCEDURE	Buccal Administration of nicotine	Oral pouch 1g, single dose. One pouch administered over 30 minutes.
PROCEDURE	Buccal Administration of nicotine	Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
PROCEDURE	Buccal Administration of nicotine	Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.

Timeline

• Start date: 2004-05-01
• Primary completion: 2004-08-01
• Completion: 2005-04-01
• First posted: 2010-11-29
• Last updated: 2010-11-29

Locations

1 site across 1 country: Sweden