Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT06118502
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2023-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'An Adaptive, Multi-Randomization Design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 544}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-responders after initial course of FDA-approved medication', 'timeFrame': '8 weeks', 'description': '7-day point prevalence abstinence at Week 8 among non-responders at Week 4'}], 'secondaryOutcomes': [{'measure': 'Dependence and duration of longest quit attempt', 'timeFrame': '12 weeks', 'description': '7-day point prevalence abstinence at Week 12 among non-responders at Week 8.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cigarette Smoking', 'Smoking Behaviors', 'Treatment']}, 'descriptionModule': {'briefSummary': 'This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.\n\nAll visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.', 'detailedDescription': 'Treatment seeking smokers across both Alabama and South Carolina (N=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination NRT (patch + lozenge), counterbalanced. Using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination NRT. Those who do not demonstrate early success will be randomized to a subsequent 4-week course of either a) continuation of same medication, or b) switch to the other FDA approved option, either varenicline or combination NRT. The same process will repeat at Week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. End of treatment outcomes will be assessed at Week 12 at which time no more product will be offered. Final follow-up at Week 24 will ascertain all primary (cessation) and secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokers who want to quit\n\nExclusion Criteria:\n\n* Non-smokers'}, 'identificationModule': {'nctId': 'NCT06118502', 'acronym': 'ADAPT', 'briefTitle': 'A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse', 'orgStudyIdInfo': {'id': '00128175'}, 'secondaryIdInfos': [{'id': '1R01CA284649-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA284649-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adaptive Randomization 1', 'description': 'This arm includes people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to medication will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again', 'interventionNames': ['Behavioral: Switching to a different medication']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Adaptive Randomization 1', 'description': 'This arm includes people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to the medication will receive four additional weeks of the same medication with instructions to try to quit again', 'interventionNames': ['Behavioral: Continued use of the same medication']}, {'type': 'EXPERIMENTAL', 'label': 'Harm Reduction Randomization 2', 'description': 'This arm includes people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both). After two 4-week courses of pharmacotherapy, participants who are not responding to medication will be randomly assigned to a harm reduction group (e-cigarettes). Participants assigned to the harm reduction group will receive four weeks of e-cigarette product with instructions to switch completely', 'interventionNames': ['Behavioral: Switching to a harm reduction tobacco product']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Adaptive Randomization 2', 'description': 'This arm includes people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both sequentially). After two four-week courses of pharmacotherapy, participants that are not responding to the medication will receive four additional weeks of the same medication with instructions to try to quit again.', 'interventionNames': ['Behavioral: Continued use of the same medication']}], 'interventions': [{'name': 'Switching to a different medication', 'type': 'BEHAVIORAL', 'description': 'Participants will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again at week 4.', 'armGroupLabels': ['Adaptive Randomization 1']}, {'name': 'Continued use of the same medication', 'type': 'BEHAVIORAL', 'description': 'Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.', 'armGroupLabels': ['Non-Adaptive Randomization 1', 'Non-Adaptive Randomization 2']}, {'name': 'Switching to a harm reduction tobacco product', 'type': 'BEHAVIORAL', 'description': 'Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8', 'armGroupLabels': ['Harm Reduction Randomization 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William McCamy', 'role': 'CONTACT', 'email': 'mccamy@musc.edu'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Tracy T Smith, PhD', 'role': 'CONTACT', 'email': 'smithtra@musc.edu', 'phone': '8438725164'}, {'name': 'Matthew J Carpenter, PhD', 'role': 'CONTACT', 'email': 'carpente@musc.edu', 'phone': '8438762436'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tracy Smith', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}