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

NCT ID: NCT01249339

Last Updated: 2010-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Smoking Cessation Smokeless Tobacco Harm Reduction

Keywords

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smokeless tobacco Nicotine Cadmium lead Tobacco Specific Nitrosamines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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General 1 g pouch

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

Group Type ACTIVE_COMPARATOR

Buccal Administration of nicotine

Intervention Type PROCEDURE

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

Catch Licoice 1 g pouch

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

Group Type ACTIVE_COMPARATOR

Buccal Administration of nicotine

Intervention Type PROCEDURE

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

Catch Licorice Mini 0.5 g pouch

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

Group Type ACTIVE_COMPARATOR

Buccal Administration of nicotine

Intervention Type PROCEDURE

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

Catch Licorice dry mini 0.3 g pouch

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

Group Type ACTIVE_COMPARATOR

Buccal Administration of nicotine

Intervention Type PROCEDURE

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

Interventions

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Buccal Administration of nicotine

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

Intervention Type PROCEDURE

Buccal Administration of nicotine

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

Intervention Type PROCEDURE

Buccal Administration of nicotine

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

Intervention Type PROCEDURE

Buccal Administration of nicotine

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

Intervention Type PROCEDURE

Other Intervention Names

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Smokeless tobacco ST Potential Exposure Reduced Product PREP Smokeless tobacco ST Potential Exposure Reduced Product PREP Smokeless tobacco ST Potential Exposure Reduced Product PREP Smokeless tobacco ST Potential Exposure Reduced Product PREP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swedish Match AB

INDUSTRY

Sponsor Role collaborator

Contract Research Organization el AB

INDUSTRY

Sponsor Role lead

Responsible Party

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CROel AB

Principal Investigators

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Erik Lunell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Croel AB

Locations

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CROel AB

Helsingborg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2004/3/2

Identifier Type: -

Identifier Source: org_study_id