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In-vivo Extraction of Pb, Cd and TSNA 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:
NCT01369693
First received: November 16, 2010
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

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

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


Secondary Outcome Measures:
  • in-vivo extraction of tobacco specific nitrosamines (TSNAs) [ 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


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 Portion 1 g pouch Procedure: Buccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other Names:
  • Smokeless Tobacco
  • ST
  • Potential reduced exposure products
  • PREP
Active Comparator: Catch Licorice Portion 1 g pouch Procedure: Buccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other Names:
  • Smokeless Tobacco
  • ST
  • Potential reduced exposure products
  • PREP
Active Comparator: Catch Licorice Portion Mini 0.5 g pouch Procedure: Buccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other Names:
  • Smokeless Tobacco
  • ST
  • Potential reduced exposure products
  • PREP
Active Comparator: Catch Licorice Portion Dry Mini 0.3 g pouch Procedure: Buccal administration of nicotine
Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other Names:
  • Smokeless Tobacco
  • ST
  • Potential reduced exposure products
  • 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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369693

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

No publications provided

Responsible Party: Erik Lunell, MD, PhD, CROel AB
ClinicalTrials.gov Identifier: NCT01369693     History of Changes
Other Study ID Numbers: 2004/3
Study First Received: November 16, 2010
Last Updated: June 8, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Smoking
Habits
Lobeline
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013