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

This study has been completed.
Sponsor:
Collaborator:
Swedish Match AB
Information provided by:
Contract Research Organization el AB
ClinicalTrials.gov Identifier:
NCT01249339
First received: November 25, 2010
Last updated: November 26, 2010
Last verified: November 2010
History of Changes

November 25, 2010
November 26, 2010
May 2004
August 2004   (final data collection date for primary outcome measure)
In-vivo extraction of cadmium [ Time Frame: 30 minutes' use ] [ Designated as safety issue: Yes ]
Extracted amount = mean of 10 unused sachets - residual amount
Same as current
Complete list of historical versions of study NCT01249339 on ClinicalTrials.gov Archive Site
  • in-vivo extraction of tobacco specific nitrosamines (TSNAs) [ Time Frame: 30 minutes' use ] [ Designated as safety issue: Yes ]
    Extracted amount = mean of 10 unused sachets - residual amount in used sachet
  • In-vivo extraction of lead [ Time Frame: 30 minutes' use ] [ Designated as safety issue: Yes ]
    Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
  • In-vivo extraction of nicotine [ Time Frame: 30 minutes' use ] [ Designated as safety issue: Yes ]
    Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
Same as current
Not Provided
Not Provided
 
In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus
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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Smoking Cessation
  • Smokeless Tobacco
  • Harm Reduction
  • 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: General 1 g pouch
    Oral pouch 0.3-1g, single dose. One pouch administered over 30 minutes.
    Intervention: Procedure: Buccal Administration of nicotine
  • Active Comparator: Catch Licoice 1 g pouch
    Oral pouch 1g, single dose. One pouch administered over 30 minutes.
    Intervention: Procedure: Buccal Administration of nicotine
  • Active Comparator: Catch Licorice Mini 0.5 g pouch
    Oral pouch 0.5g, single dose. One pouch administered over 30 minutes.
    Intervention: Procedure: Buccal Administration of nicotine
  • Active Comparator: Catch Licorice dry mini 0.3 g pouch
    Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
    Intervention: Procedure: Buccal Administration of nicotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2005
August 2004   (final data collection date for primary outcome measure)

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.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01249339
2004/3/2
No
Erik Lunell, MD, PhD, CROel AB
Contract Research Organization el AB
Swedish Match AB
Principal Investigator: Erik Lunell, MD, PhD Croel AB
Contract Research Organization el AB
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP