In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- In-vivo extraction of cadmium
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
In-vivo extraction of cadmium
Time Frame: 30 minutes' use
Extracted amount = mean of 10 unused sachets - residual amount
Secondary Outcomes
- in-vivo extraction of tobacco specific nitrosamines (TSNAs)(30 minutes' use)
- In-vivo extraction of lead(30 minutes' use)
- In-vivo extraction of nicotine(30 minutes' use)
Investigators
Erik Lunell, MD, PhD
MD, PhD
Contract Research Organization el AB