Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-09 @ 4:03 PM
Study NCT ID:
NCT01842828
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2013-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UK-Czech E-cigarette Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D066300', 'term': 'Electronic Nicotine Delivery Systems'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-02', 'studyFirstSubmitDate': '2013-04-23', 'studyFirstSubmitQcDate': '2013-04-25', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carbon monoxide (CO)-validated continuous abstinence rates at 4 weeks post-TQD', 'timeFrame': 'Four weeks'}], 'secondaryOutcomes': [{'measure': 'Carbon monoxide (CO)-validated abstinence rates at 24 weeks post-TQD', 'timeFrame': 'Four weeks'}, {'measure': 'Ratings of cigarette withdrawal at 1 and 4 weeks post-TQD', 'timeFrame': 'Four weeks'}, {'measure': 'Electronic cigarette use', 'timeFrame': '24 weeks'}, {'measure': 'Electronic cigarette taste and satisfaction in comparison to conventional cigarettes', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'Currently available smoking cessation treatments help only about 15% of smokers to quit long-term. These treatments do not typically address the behaviours and sensations associated with the act of smoking (e.g. handling a cigarette, inhaling, taste and feel of smoke on the throat). There is evidence that these elements influence smoking behaviour and cessation. Electronic cigarettes (EC) are a new product with a strong potential to be a realistic behavioural replacement for smoking.\n\nWhilst EC deliver nicotine, their use does not involve tobacco combustion, which is the primary source of the many thousands of dangerous chemicals to which smokers of conventional cigarettes are exposed. Studies on EC products and users indicate there is little doubt that they are substantially safer than conventional cigarettes.\n\nThe investigators plan to conduct a study one of the very first studies to test the effects of adding EC to standard care on long-term validated outcomes. Before launching such a large and demanding trial however, data are needed on what proportion of smokers would be interested in using EC and what compliance with EC use can be expected, and no data exist to inform how large a sample is needed. This pilot study would provide such data.\n\nA total of 200 smokers would be recruited at smoking cessation clinics in London and Prague. Half the smokers would be randomised to receive standard smoking cessation behavioural support and medication (standard care; SC), and half to receive SC plus EC. The EC group would receive a four week supply of EC. The outcome measures for the study would be smoking status at 4 and 24 weeks after the target quit date, EC use, acceptability, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokers who want help with quitting\n* Aged 18 or over\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, planning to conceive in the next 6 months\n* Enrolled in other research\n* Currently using electronic cigarettes'}, 'identificationModule': {'nctId': 'NCT01842828', 'acronym': '(SUKCES)', 'briefTitle': 'UK-Czech E-cigarette Study', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'E-Cigarettes as an Addition to Multi-component Treatment for Tobacco Dependence: A Pilot Study', 'orgStudyIdInfo': {'id': 'QMUL201208b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care plus electronic cigarettes', 'description': 'Standard care for smoking cessation plus electronic cigarettes', 'interventionNames': ['Other: Standard care plus electronic cigarettes']}, {'type': 'OTHER', 'label': 'Standard care', 'description': 'Standard care for smoking cessation', 'interventionNames': ['Other: Standard care plus electronic cigarettes', 'Behavioral: Standard care']}], 'interventions': [{'name': 'Standard care plus electronic cigarettes', 'type': 'OTHER', 'armGroupLabels': ['Standard care', 'Standard care plus electronic cigarettes']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Tobacco Dependence Research Unit, Queen Mary University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Peter Hajek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University of London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}