- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01369693
In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus (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
Intervention / Treatment
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: General Portion 1 g pouch
|
Oral pouch, oral sachet, 0.3-1g, single dose.
One pouch administered between upper lip and gum over 30 minutes
Other Names:
|
Active Comparator: Catch Licorice Portion 1 g pouch
|
Oral pouch, oral sachet, 0.3-1g, single dose.
One pouch administered between upper lip and gum over 30 minutes
Other Names:
|
Active Comparator: Catch Licorice Portion Mini 0.5 g pouch
|
Oral pouch, oral sachet, 0.3-1g, single dose.
One pouch administered between upper lip and gum over 30 minutes
Other Names:
|
Active Comparator: Catch Licorice Portion Dry Mini 0.3 g pouch
|
Oral pouch, oral sachet, 0.3-1g, single dose.
One pouch administered between upper lip and gum 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 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
|
in-vivo extraction of tobacco specific nitrosamines (TSNAs)
|
Extracted amount = mean of 10 unused sachets - residual amount in used sachet
|
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
- 2004/3
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.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Buccal administration of nicotine
-
Contract Research Organization el ABSwedish Match ABCompletedSmoking Cessation | Harm Reduction | Smokeless TobaccoSweden
-
Contract Research Organization el ABSwedish Match ABCompletedSmoking Cessation | Harm ReductionSweden
-
Tanta UniversityRecruitingOro-Antral CommunicationEgypt
-
M.D. Anderson Cancer CenterNational Institute on Drug Abuse (NIDA)Active, not recruitingCigarette Smoking-Related Carcinoma | Tobacco-Related CarcinomaUnited States
-
Region GävleborgMalmö University; Swedish Dental Associations Scientific Funds; Department of... and other collaboratorsCompletedOrthodontic Anchorage Procedures | Orthodontic Space ClosureSweden
-
Ohio State University Comprehensive Cancer CenterNational Institute on Drug Abuse (NIDA)Not yet recruitingCigarette Smoking-Related CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Institute on Drug Abuse (NIDA)RecruitingCigarette Smoking-Related CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCurrent Every Day SmokerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingCurrent Smoker | Healthy SubjectUnited States
-
Alexandria UniversityActive, not recruitingAnesthesia, LocalEgypt