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

Smoking Cessation Clinical Trial

— SMWS03  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249339
• Other study ID #: 2004/3/2
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2010
• Last updated: November 26, 2010
• Start date: May 2004
• Est. completion date: April 2005

Study information

• Verified date: November 2010
• Source: Contract Research Organization el AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2005
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Harm Reduction
• Smokeless Tobacco
• Smoking Cessation

Intervention

Procedure:
• Buccal Administration of nicotine
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
• Buccal Administration of nicotine
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
• Buccal Administration of nicotine
Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
• Buccal Administration of nicotine
Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.

Locations

Country	Name	City	State
Sweden	CROel AB	Helsingborg

Sponsors (2)

Lead Sponsor	Collaborator
Contract Research Organization el AB	Swedish Match AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-vivo extraction of cadmium	Extracted amount = mean of 10 unused sachets - residual amount	30 minutes' use	Yes
Secondary	in-vivo extraction of tobacco specific nitrosamines (TSNAs)	Extracted amount = mean of 10 unused sachets - residual amount in used sachet	30 minutes' use	Yes
Secondary	In-vivo extraction of lead	Extracted amount = mean of 10 unused sachets - residual amount in one used sachet	30 minutes' use	Yes
Secondary	In-vivo extraction of nicotine	Extracted amount = mean of 10 unused sachets - residual amount in one used sachet	30 minutes' use	Yes