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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249339
First Posted: November 29, 2010
Last Update Posted: November 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Swedish Match AB
Information provided by:
Contract Research Organization el AB
  Purpose
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 Intervention Phase
Smoking Cessation Smokeless Tobacco Harm Reduction Procedure: Buccal Administration of nicotine Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Contract Research Organization el AB:

Primary Outcome Measures:
  • In-vivo extraction of cadmium [ Time Frame: 30 minutes' use ]
    Extracted amount = mean of 10 unused sachets - residual amount


Secondary Outcome Measures:
  • 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

  • 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


Enrollment: 32
Study Start Date: May 2004
Study Completion Date: April 2005
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249339


Locations
Sweden
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
  More Information

Responsible Party: Erik Lunell, MD, PhD, CROel AB
ClinicalTrials.gov Identifier: NCT01249339     History of Changes
Other Study ID Numbers: 2004/3/2
First Submitted: November 25, 2010
First Posted: November 29, 2010
Last Update Posted: November 29, 2010
Last Verified: November 2010

Keywords provided by Contract Research Organization el AB:
smokeless tobacco
Nicotine
Cadmium
lead
Tobacco Specific Nitrosamines

Additional relevant MeSH terms:
Nicotine
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents