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

November 26, 2010 updated by: Contract Research Organization el AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Helsingborg, Sweden, SE25284
        • CROel AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General 1 g pouch
Oral pouch 0.3-1g, single dose. One pouch administered over 30 minutes.
Procedure: Buccal Administration of nicotine
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Procedure: Buccal Administration of nicotine
Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Procedure: Buccal Administration of nicotine
Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Active Comparator: Catch Licoice 1 g pouch
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Procedure: Buccal Administration of nicotine
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Procedure: Buccal Administration of nicotine
Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Procedure: Buccal Administration of nicotine
Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Active Comparator: Catch Licorice Mini 0.5 g pouch
Oral pouch 0.5g, single dose. One pouch administered over 30 minutes.
Procedure: Buccal Administration of nicotine
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Procedure: Buccal Administration of nicotine
Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Procedure: Buccal Administration of nicotine
Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Active Comparator: Catch Licorice dry mini 0.3 g pouch
Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
Procedure: Buccal Administration of nicotine
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Procedure: Buccal Administration of nicotine
Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP
Procedure: Buccal Administration of nicotine
Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-vivo extraction of cadmium
Time Frame: 30 minutes' use
Extracted amount = mean of 10 unused sachets - residual amount
30 minutes' use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-vivo extraction of tobacco specific nitrosamines (TSNAs)
Time Frame: 30 minutes' use
Extracted amount = mean of 10 unused sachets - residual amount in used sachet
30 minutes' use
In-vivo extraction of lead
Time Frame: 30 minutes' use
Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
30 minutes' use
In-vivo extraction of nicotine
Time Frame: 30 minutes' use
Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
30 minutes' use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Contract Research Organization el AB

Collaborators

Swedish Match AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

November 25, 2010

First Submitted That Met QC Criteria

November 26, 2010

First Posted (Estimate)

November 29, 2010

Study Record Updates

Last Update Posted (Estimate)

November 29, 2010

Last Update Submitted That Met QC Criteria

November 26, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004/3/2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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