Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 2:39 AM
Study NCT ID:
NCT00265460
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2005-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smoking Cessation in Groups and With Tobacco Pastils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062789', 'term': 'Tobacco Products'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2005-12-13', 'studyFirstSubmitQcDate': '2005-12-13', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuous Smoking cessation quit rate after 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Side effects from tested tobacco product'}, {'measure': 'Intake of nicotine and thiocyanate'}]}, 'conditionsModule': {'keywords': ['smoking cessation,', 'nicotine,', 'smokeless tobacco,', 'cigarettes'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '18686184', 'type': 'RESULT', 'citation': 'Tonnesen P, Mikkelsen K, Bremann L. Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial. Nicotine Tob Res. 2008 Aug;10(8):1365-72. doi: 10.1080/14622200802238969.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.', 'detailedDescription': 'The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoking \\> 13 cigarettes/day\n* healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)\n* motivated for cessation\n* motivated to use tobacco pastils\n* motivated for group support\n\nExclusion Criteria:\n\n* severe diseases\n* psychiatric diseases\n* using antipsychotic drugs\n* used NRT/bupropion in the last 3 months\n* consuming \\> 6 drinks/day\n* pregnant/lactating\n* stopped smoking more than 2 days during last 3 months'}, 'identificationModule': {'nctId': 'NCT00265460', 'briefTitle': 'Smoking Cessation in Groups and With Tobacco Pastils', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation', 'orgStudyIdInfo': {'id': 'Tonga.2005.00.'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oliwer Twist smokeless tobacco (tobacco)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Copenhagen', 'state': 'Hellerup', 'country': 'Denmark', 'facility': 'Dept. pulmonary medicine Y, Gentofte University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Philip Tønnesen, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chair dept. pulm. medicine, Gentofte Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}}}}