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

Sponsor
Contract Research Organization el AB (Industry)
Overall Status
Completed
CT.gov ID
NCT01249339
Collaborator
Swedish Match AB (Industry)
32
Enrollment
1
Location
4
Arms
11
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Buccal Administration of nicotine
  • Procedure: Buccal Administration of nicotine
  • Procedure: Buccal Administration of nicotine
  • Procedure: Buccal Administration of nicotine
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users
Study Start Date :
May 1, 2004
Actual Primary Completion Date :
Aug 1, 2004
Actual Study Completion Date :
Apr 1, 2005

Arms and Interventions

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

    		•
    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

    		•
    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 0.5 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 0.3 g, single dose. One pouch administered over 30 minutes.
    Other Names:
  • Smokeless tobacco
  • ST
  • Potential Exposure Reduced Product
  • PREP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. In-vivo extraction of cadmium [30 minutes' use]

      Extracted amount = mean of 10 unused sachets - residual amount

    Secondary Outcome Measures

    1. in-vivo extraction of tobacco specific nitrosamines (TSNAs) [30 minutes' use]

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

    2. In-vivo extraction of lead [30 minutes' use]

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

    3. In-vivo extraction of nicotine [30 minutes' use]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CROel AB Helsingborg Sweden SE25284

    Sponsors and Collaborators

    • Contract Research Organization el AB
    • Swedish Match AB

    Investigators

    • Principal Investigator: Erik Lunell, MD, PhD, Croel AB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01249339
    Other Study ID Numbers:
    • 2004/3/2
    First Posted:
    Nov 29, 2010
    Last Update Posted:
    Nov 29, 2010
    Last Verified:
    Nov 1, 2010
    Keywords provided by , ,
    smokeless tobacco
    Nicotine
    Cadmium
    lead
    Tobacco Specific Nitrosamines
    Additional relevant MeSH terms:
    Lobeline
    Nicotine

    Study Results

    No Results Posted as of Nov 29, 2010