Completed

NCT Number: NCT01369693

In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus

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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Key information

Conditions

Smoking Cessation Behavior Harm Reduction Health Behavior Smokeless Tobacco Tobacco Use

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CROel AB

Helsingborg, SE25284, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buccal Administration of nicotine

Procedure

Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes

Other names: Smokeless Tobacco, ST, Potential reduced exposure products, PREP

Primary outcomes

In-vivo extraction of cadmium

Time frame: 30 minutes' use

Extracted amount = mean of 10 unused sachets - residual amount

Secondary outcomes

in-vivo extraction of tobacco specific nitrosamines (TSNAs)

Extracted amount = mean of 10 unused sachets - residual amount in used sachet
In-vivo extraction of lead

Time frame: 30 minutes' use

Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
In-vivo extraction of nicotine

Time frame: 30 minutes' use

Extracted amount = mean of 10 unused sachets - residual amount in one used sachet

Sponsors and collaborators

Lead sponsor

Contract Research Organization el AB

Industry

Collaborators

Swedish Match AB

Registry information

Official study title

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

Acronym: SMWS03

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2005
First posted: Jun 9, 2011
Registry last updated: Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed