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

Phase 1

Completed

• Conditions: Smokeless Tobacco; Smoking Cessation; Harm Reduction

• Registration Number: NCT01249339
• Lead Sponsor: Contract Research Organization el AB

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.

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2004-08
• Study Completion: 2005-04
• Status Verified: 2010-11
• Study First Submitted: 2010-11-25
• Study First Submitted QC: 2010-11-26
• Last Update Submitted: 2010-11-26
• Study First Posted: 2010-11-29
• Last Update Posted: 2010-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
In-vivo extraction of cadmium	30 minutes' use	Extracted amount = mean of 10 unused sachets - residual amount

Secondary Outcome Measures

Name	Time	Method
in-vivo extraction of tobacco specific nitrosamines (TSNAs)	30 minutes' use	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
In-vivo extraction of nicotine	30 minutes' use	Extracted amount = mean of 10 unused sachets - residual amount in one used sachet

Trial Locations

Locations (1)

CROel AB; 🇸🇪 Helsingborg, Sweden