Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT01369693
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2010-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D040261', 'term': 'Harm Reduction'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014030', 'term': 'Tobacco, Smokeless'}], 'ancestors': [{'id': 'D062789', 'term': 'Tobacco Products'}, {'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-08', 'studyFirstSubmitDate': '2010-11-16', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-vivo extraction of cadmium', 'timeFrame': "30 minutes' use", 'description': 'Extracted amount = mean of 10 unused sachets - residual amount'}], 'secondaryOutcomes': [{'measure': 'in-vivo extraction of tobacco specific nitrosamines (TSNAs)', 'description': 'Extracted amount = mean of 10 unused sachets - residual amount in used sachet'}, {'measure': 'In-vivo extraction of lead', 'timeFrame': "30 minutes' use", 'description': 'Extracted amount = mean of 10 unused sachets - residual amount in one used sachet'}, {'measure': 'In-vivo extraction of nicotine', 'timeFrame': "30 minutes' use", 'description': 'Extracted amount = mean of 10 unused sachets - residual amount in one used sachet'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smokeless tobacco', 'Nicotine', 'Cadmium', 'lead', 'Tobacco Specific Nitrosamines'], 'conditions': ['Smoking Cessation', 'Smokeless Tobacco', 'Harm Reduction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Comparisons:\n\nA= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.\n\nB= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.\n\nC= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.\n\nD= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.\n\nSwedish 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-smokers, 18 to 50 years of age.\n* Habitual use of \\> 7 portions snus daily since minimum 1 year.\n* Healthy according to the health declaration and interview.\n* Written informed consent given.\n\nExclusion Criteria:\n\n* Concurrent participation in another clinical trial.\n* History of allergy.\n* History of allergy.'}, 'identificationModule': {'nctId': 'NCT01369693', 'acronym': 'SMWS03', 'briefTitle': 'In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Contract Research Organization el AB'}, 'officialTitle': "In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.", 'orgStudyIdInfo': {'id': '2004/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'General Portion 1 g pouch', 'interventionNames': ['Procedure: Buccal administration of nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Catch Licorice Portion 1 g pouch', 'interventionNames': ['Procedure: Buccal administration of nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Catch Licorice Portion Mini 0.5 g pouch', 'interventionNames': ['Procedure: Buccal administration of nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Catch Licorice Portion Dry Mini 0.3 g pouch', 'interventionNames': ['Procedure: Buccal administration of nicotine']}], 'interventions': [{'name': 'Buccal administration of nicotine', 'type': 'PROCEDURE', 'otherNames': ['Smokeless Tobacco', 'ST', 'Potential reduced exposure products', 'PREP'], 'description': 'Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes', 'armGroupLabels': ['Catch Licorice Portion 1 g pouch', 'Catch Licorice Portion Dry Mini 0.3 g pouch', 'Catch Licorice Portion Mini 0.5 g pouch', 'General Portion 1 g pouch']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE25284', 'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'CROel AB', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}], 'overallOfficials': [{'name': 'Erik Lunell, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Croel AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Contract Research Organization el AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Swedish Match AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Erik Lunell, MD, PhD', 'oldOrganization': 'CROel AB'}}}}