- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01838473
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users (SMWS03)
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Helsingborg, Sweden, SE25284
- CROel AB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: General 1 g pouch
Oral pouch 0.3-1g, single dose.
One pouch administered over 30 minutes.
Buccal Administration of nicotine.
|
Oral pouch 1g, single dose.
One pouch administered over 30 minutes.
Other Names:
Oral pouch 0.5 g, single dose.
One pouch administered over 30 minutes.
Other Names:
Oral pouch 0.3 g, single dose.
One pouch administered over 30 minutes.
Other Names:
|
ACTIVE_COMPARATOR: Catch Licoice 1 g pouch
Oral pouch 1g, single dose.
One pouch administered over 30 minutes.
Buccal Administration of nicotine.
|
Oral pouch 1g, single dose.
One pouch administered over 30 minutes.
Other Names:
Oral pouch 0.5 g, single dose.
One pouch administered over 30 minutes.
Other Names:
Oral pouch 0.3 g, single dose.
One pouch administered over 30 minutes.
Other Names:
|
ACTIVE_COMPARATOR: Catch Licorice Mini 0.5 g pouch
Oral pouch 0.5g, single dose.
One pouch administered over 30 minutes.
Buccal Administration of nicotine.
|
Oral pouch 1g, single dose.
One pouch administered over 30 minutes.
Other Names:
Oral pouch 0.5 g, single dose.
One pouch administered over 30 minutes.
Other Names:
Oral pouch 0.3 g, single dose.
One pouch administered over 30 minutes.
Other Names:
|
ACTIVE_COMPARATOR: Catch Licorice dry mini 0.3 g pouch
Oral pouch 0.3 g, single dose.
One pouch administered over 30 minutes.
Buccal Administration of nicotine.
|
Oral pouch 1g, single dose.
One pouch administered over 30 minutes.
Other Names:
Oral pouch 0.5 g, single dose.
One pouch administered over 30 minutes.
Other Names:
Oral pouch 0.3 g, single dose.
One pouch administered over 30 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-vivo extraction of cadmium
Time Frame: 30 minutes' use
|
Extracted amount = mean of 10 unused sachets - residual amount
|
30 minutes' use
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 minutes' use
|
In-vivo extraction of lead
Time Frame: 30 minutes' use
|
Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
|
30 minutes' use
|
In-vivo extraction of nicotine
Time Frame: 30 minutes' use
|
Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
|
30 minutes' use
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMWS03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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