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

NCT01249339 — Phase 1, Completed, 32 participants, Contract Research Organization el AB

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

Registry	NCT01249339, acronym SMWS03
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: single, basic science
Enrollment	32 (Actual)
Sponsor	Contract Research Organization el AB (Industry); collaborators: Swedish Match AB
Conditions	Smoking Cessation, Smokeless Tobacco, Harm Reduction
Interventions	Buccal Administration of nicotine (Procedure)
Dates	start 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 in Sweden

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
General 1 g pouch	Active comparator	Procedure: Buccal Administration of nicotine	Oral pouch 0.3-1g, single dose. One pouch administered over 30 minutes.
Catch Licoice 1 g pouch	Active comparator	Procedure: Buccal Administration of nicotine	Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Catch Licorice Mini 0.5 g pouch	Active comparator	Procedure: Buccal Administration of nicotine	Oral pouch 0.5g, single dose. One pouch administered over 30 minutes.
Catch Licorice dry mini 0.3 g pouch	Active comparator	Procedure: Buccal Administration of nicotine	Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.

Buccal Administration of nicotine (Procedure), also known as Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP: Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Buccal Administration of nicotine (Procedure), also known as Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP: Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Buccal Administration of nicotine (Procedure), also known as Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP: Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
Buccal Administration of nicotine (Procedure), also known as Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP: Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.

+Outcome measures

Primary outcomes

In-vivo extraction of cadmium [30 minutes' use]: Extracted amount = mean of 10 unused sachets - residual amount

Secondary outcomes

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

+Eligibility

Sex: Male, ages: 18 Years to 50 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
CROel AB	Helsingborg	Sweden

+Investigators

Erik Lunell, MD, PhD, Principal investigator, Croel AB