Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT07040566
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Varenicline for E-cigarette Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adults who report regular e-cigarette use'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 326}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Abstinent From E-cigarette Use at Week 12', 'timeFrame': 'Week 12', 'description': '7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use \\[and no use of any combusted tobacco product\\], not even a puff, biochemically verified by saliva cotinine'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Abstinent From E-cigarette Use at Week 26', 'timeFrame': 'Week 26', 'description': '7-day point-prevalence e-cigarette abstinence (PPA) at Week 26 defined as no ecigarette use \\[and no use of any combusted tobacco product\\], not even a puff, biochemically verified by saliva cotinine'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['E-cigarette Use', 'Vaping', 'Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.', 'detailedDescription': 'Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26.\n\nThe primary objective is to test the efficacy of varenicline vs. placebo on e-cigarette quit rates. We will also evaluate predictors and moderators of outcomes and explore changes in health biomarkers following e-cigarette cessation treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* report daily use of an e-cigarette containing nicotine\n* live in Connecticut or South Carolina\n\nExclusion Criteria:\n\n* regular use of other tobacco products besides e-cigarettes\n* medical contraindications for varenicline use\n* current treatment for tobacco cessation\n* lack proficiency in English'}, 'identificationModule': {'nctId': 'NCT07040566', 'briefTitle': 'A Trial of Varenicline for E-cigarette Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults', 'orgStudyIdInfo': {'id': '2000038513'}, 'secondaryIdInfos': [{'id': '1R01CA296186-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA296186-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varenicline', 'description': 'Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) plus brief cessation advice with a counselor and self-management resources.', 'interventionNames': ['Drug: Varenicline 1mg BID']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Varenicline 1mg BID', 'type': 'DRUG', 'description': '12 weeks following the standard titration of 1 mg, twice daily', 'armGroupLabels': ['Varenicline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hollings Cancer Center at MUSC (HCC)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Lisa Fucito, PhD', 'role': 'CONTACT', 'email': 'lisa.fucito@yale.edu', 'phone': '2032001470'}, {'name': 'Michael Fatigate, PhD', 'role': 'CONTACT', 'email': 'Michael.fatigate@yale.edu'}], 'overallOfficials': [{'name': 'Lisa Fucito, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Benjamin Toll, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Data will be shared to an NIH data repository - the NIMH Data Archive', 'accessCriteria': 'Access to the data is managed by the NIMH Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}