Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT00313105
Status:
UNKNOWN
Last Update Posted:
2009-09-15
First Post:
2006-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2006-04-10', 'studyFirstSubmitQcDate': '2006-04-10', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence from smoking after ½ year (point and continuous abstinence)', 'timeFrame': '6 months from entry'}], 'secondaryOutcomes': [{'measure': 'Adverse events between 3 arms', 'timeFrame': 'Up to 6 months from entry'}, {'measure': 'Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)', 'timeFrame': '3 and 6 months from entry'}, {'measure': 'Adherence to study', 'timeFrame': '6,12,24 months from entry'}, {'measure': 'Effect of retreatment (abstinence after 1, 1½ and 2 years)', 'timeFrame': '12,18 and 24 months from entry'}, {'measure': 'Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status', 'timeFrame': '6,12,24 months from entry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking cessation', 'smokeless tobacco', 'nicotine patch', 'nicotine buccal tablets', 'retreatment', 'adherence'], 'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches.\n\nAlso retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.', 'detailedDescription': 'This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smokers (\\>7 cig/day)\n* Healthy\n* Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases\n* mild asthma and COPD,\n* Motivated to quit smoking\n* Motivated to follow the protocol\n* Motivated to use medication in this trial\n\nExclusion Criteria:\n\n* Severe diseases\n* Psychiatric diseases\n* Used NRT or Zyban the last 2 weeks\n* Stopped smoking \\>2 days during last 3 months\n* More than 6 alcoholic drinks per day\n* Smokes other products than cigarettes\n* Pregnant of lactating'}, 'identificationModule': {'nctId': 'NCT00313105', 'briefTitle': 'Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years', 'orgStudyIdInfo': {'id': '2005-004626-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smokeless Tobacco', 'description': 'Smokeless Tobacco and individual visits', 'interventionNames': ['Drug: Smokeless tobacco (Oliver Twist pellets)', 'Behavioral: smoking cessation counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine tablets', 'description': 'Nicotine tablets', 'interventionNames': ['Behavioral: smoking cessation counseling']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': '7-mg nicotine patch acts as placebo', 'interventionNames': ['Behavioral: smoking cessation counseling']}], 'interventions': [{'name': 'Smokeless tobacco (Oliver Twist pellets)', 'type': 'DRUG', 'description': 'individual visits with counseling', 'armGroupLabels': ['Smokeless Tobacco']}, {'name': 'smoking cessation counseling', 'type': 'BEHAVIORAL', 'description': 'individual visits', 'armGroupLabels': ['3', 'Nicotine tablets', 'Smokeless Tobacco']}]}, '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': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chair dept. pulm. medicine, Gentofte Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Research Foundation, FSS, Copenhagen, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Philip Tønnesen, M.D.', 'oldOrganization': 'Gentofte Hospital'}}}}