Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-02 @ 12:12 AM
Study NCT ID:
NCT06472869
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-19', 'releaseDate': '2025-12-04'}, {'releaseDate': '2025-12-23'}], 'estimatedResultsFirstSubmitDate': '2025-12-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label single-arm pilot clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study feasibility', 'timeFrame': '4 weeks', 'description': 'Participant enrollment, measured by the proportion of eligible participants following in-person screening who enroll in the study. Retention is measured by weeks of study participation.'}, {'measure': 'Cigarettes per day (CPD) smoked during the period of e-cigarette provision', 'timeFrame': '4 weeks', 'description': 'Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4)'}], 'secondaryOutcomes': [{'measure': 'Carbon monoxide (CO) concentration in expired air', 'timeFrame': '4 weeks', 'description': "Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4)"}, {'measure': 'Urine anabasine concentration', 'timeFrame': '4 weeks', 'description': "Change in participant's urine anabasine concentration during the period of e-cigarette provision (baseline to week 4)"}, {'measure': 'Urine cotinine concentration', 'timeFrame': '4 weeks', 'description': "Change in concentration of cotinine (nicotine metabolite) in participant's urine during e-cigarette provision (baseline to week4)"}, {'measure': 'Cigarettes smoked per day after e-cigarette provision ends', 'timeFrame': '4 weeks (Weeks 4-8)', 'description': 'Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco Use Disorder'], 'conditions': ['Electronic Cigarette Use', 'Smoking, Cigarette', 'Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks).\n\nThe first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who completed the Screen Assist study (NCT03611881) and self-reported smoking cigarettes at the end of the study were asked to complete a survey to ascertain their potential interest in participating in a research study to test the effects of switching from combustible cigarettes (CC) to electronic cigarettes (EC). Individuals who expressed interest in switching to EC on that survey were screened for eligibility for this pilot study\n* Smoked ≥5 cigarettes/day in past month\n* Smoking status at study entry confirmed by breath carbon monoxide (CO) ≥ 6ppm\n* Willing to try switching from CC to EC for 4 weeks\n* Owns a mobile telephone\n* English speaking\n* Willing to travel to the Massachusetts General Hospital campus for 3 in-person visits.\n\nExclusion Criteria:\n\n* Plans to quit smoking and has set a quit date in the next 30 days\n* Used smoking cessation treatment in the past 30 days\n* Used EC on \\>2 days in the past 30 days\n* Hospitalized for acute coronary syndrome, unstable angina, congestive heart failure, stroke, pneumonia or chronic pulmonary disease/asthma exacerbation in the past 1 month\n* Not willing to abstain from smoking marijuana in the 24h before each study visit'}, 'identificationModule': {'nctId': 'NCT06472869', 'briefTitle': 'Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening', 'orgStudyIdInfo': {'id': '2024p001502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NJOY ACE e-cigarette provision', 'description': 'Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor\n\nPatients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks.', 'interventionNames': ['Other: NJOY ACE e-cigarette']}], 'interventions': [{'name': 'NJOY ACE e-cigarette', 'type': 'OTHER', 'description': 'Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks', 'armGroupLabels': ['NJOY ACE e-cigarette provision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Nancy A. Rigotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'Nancy A. Rigotti', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-04', 'type': 'RELEASE'}, {'date': '2025-12-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nancy A. Rigotti, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital'}}}}