Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 10:58 AM
Study NCT ID:
NCT05206435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-15
First Post:
2021-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methadone-Maintained Smokers Switching to E-Cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D066300', 'term': 'Electronic Nicotine Delivery Systems'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nicotine Exposure', 'timeFrame': '6 weeks', 'description': 'Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-weeks.'}, {'measure': 'FVC Lung Functioning', 'timeFrame': '6 weeks', 'description': 'Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks.'}, {'measure': 'FEV1 Lung Functioning', 'timeFrame': '6 weeks', 'description': 'Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks.'}, {'measure': 'FEV1/FVC Ratio Lung Functioning', 'timeFrame': '6 weeks', 'description': 'Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks.'}, {'measure': 'Smoking Behavior and Experiences', 'timeFrame': '6 weeks', 'description': 'Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks.'}, {'measure': 'Nicotine Exposure for Complete Switchers', 'timeFrame': '6 weeks', 'description': 'Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-week among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.'}, {'measure': 'FVC Lung Functioning for Complete Switchers', 'timeFrame': '6 weeks', 'description': 'Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.'}, {'measure': 'FEV1 Lung Functioning for Complete Switchers', 'timeFrame': '6 weeks', 'description': 'Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.'}, {'measure': 'FEV1/FVC Ratio Lung Functioning for Complete Switchers', 'timeFrame': '6 weeks', 'description': 'Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.'}, {'measure': 'Smoking Behavior and Experiences for Complete Switchers', 'timeFrame': '6 weeks', 'description': 'Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nicotine Dependence', 'Electronic Cigarette Use']}, 'descriptionModule': {'briefSummary': 'Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.', 'detailedDescription': 'Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks: baseline, 5 weekly check-in (CI) visits, and a 6-week assessment. Baseline assessments will include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.\n\nAll participants will attend weekly brief assessment check-in visits where distribution of either EC or NRT will occur. Check-in assessments will include cigarette use, EC use, NRT use, CO readings, respiratory symptoms, and tobacco demand. At the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of EC use, relative to NRT.\n\nThis study will be the first to test the potential behavioral and health effects of ECs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate to heavy cigarette smokers (10 cigarettes/day for \\> 1 yr; breath CO \\> 10 ppm)\n* have been receiving methadone for at least three months\n* attend at least weekly to receive methadone dose\n* speak English\n* have a telephone or access to a telephone\n* are available over the next 6 weeks\n* are interested in switching to either electronic cigarettes or nicotine replacement therapy\n\nExclusion Criteria:\n\n* use of ECs on \\> 2 of the past 30 days\n* currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT)\n* have unstable psychiatric conditions\n* have near-daily or daily use of marijuana\n* are pregnant\n* had a cardiovascular event in the last month\n* daily medication for asthma or COPD'}, 'identificationModule': {'nctId': 'NCT05206435', 'acronym': 'SHINE', 'briefTitle': 'Methadone-Maintained Smokers Switching to E-Cigarettes', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Methadone-Maintained Smokers Switching to E-Cigarettes', 'orgStudyIdInfo': {'id': '1702236'}, 'secondaryIdInfos': [{'id': 'R01DA052907', 'link': 'https://reporter.nih.gov/quickSearch/R01DA052907', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Electronic Cigarettes', 'description': 'Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.', 'interventionNames': ['Drug: Electronic Cigarette']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Lozenges', 'description': 'Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.', 'interventionNames': ['Drug: Nicotine Lozenge']}], 'interventions': [{'name': 'Electronic Cigarette', 'type': 'DRUG', 'description': 'Electronic Cigarettes are provided to replace tobacco cigarettes', 'armGroupLabels': ['Electronic Cigarettes']}, {'name': 'Nicotine Lozenge', 'type': 'DRUG', 'description': 'Nicotine Lozenges are provided to replace tobacco cigarettes', 'armGroupLabels': ['Nicotine Lozenges']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}