In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus (SMWS03)

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Contract Research Organization el AB

Status and phase

Completed

Phase 1

Conditions

Smokeless Tobacco

Harm Reduction

Smoking Cessation

Treatments

Procedure: Buccal Administration of nicotine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01249339

2004/3/2

Details and patient eligibility

About

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.

Full 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

32 participants in 4 patient groups

General 1 g pouch

Active Comparator group

Description:

Oral pouch 0.3-1g, single dose. One pouch administered over 30 minutes.

Treatment:

Procedure: Buccal Administration of nicotine

Catch Licoice 1 g pouch

Active Comparator group

Description:

Oral pouch 1g, single dose. One pouch administered over 30 minutes.

Treatment:

Procedure: Buccal Administration of nicotine

Catch Licorice Mini 0.5 g pouch

Active Comparator group

Description:

Oral pouch 0.5g, single dose. One pouch administered over 30 minutes.

Treatment:

Procedure: Buccal Administration of nicotine

Catch Licorice dry mini 0.3 g pouch

Active Comparator group

Description:

Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.

Treatment:

Procedure: Buccal Administration of nicotine

Trial contacts and locations

1

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