Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT07162935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-28
First Post:
2025-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073863', 'term': 'Cigar Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-03-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Puff number', 'timeFrame': 'From enrollment to the end of the final smoking visit, approximately 2 weeks', 'description': 'Number of cigarillo puffs'}, {'measure': 'Subjective reward from smoking', 'timeFrame': 'From enrollment to the end of the final smoking visit, approximately 2 weeks', 'description': 'Self-reported reward from cigarillo smoking from a questionnaire. This scale has 5 questions with response options ranging from 1 - not at all to 7 - extremely. The score is averaged across the number of items. Higher ratings indicate greater psychological reward'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cigar Smoking', 'Tobacco Use']}, 'descriptionModule': {'briefSummary': 'This clinical trial will recruit young adults who currently use cigarillos and examine the smoking behavior and perceptions of different flavored cigarillos, product ingredients/additives impacting these perceptions, and simulated tobacco use outcomes (quitting, switching) in various policy scenarios where different types of flavors are available on the market.', 'detailedDescription': 'This clinical trial will isolate the unique effects of concept descriptors on increased cigarillo use and appeal among experienced young adult cigarillo users. The study will seek to determine the addiction potential of concept flavored cigarillos by examining associations of cigarillo flavor type (concept, characterizing, tobacco) and cigarillo flavoring additives/ingredients to complementary measures of product appeal: subjective effects (e.g., satisfaction, reward, taste), actual smoking behavior (e.g., number of puffs), and simulated cigarillo purchasing, other tobacco product substitution, or quitting under different flavor ban scenarios via an Experimental Tobacco Marketplace (ETM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 18 to 24\n2. Report past 30-day use of a cigarillo\n3. Ability to read English at least an 8th grade level\n4. No immediate plans to quit using tobacco\n5. At least 1 prior experience with a flavored tobacco product\n6. U.S. Citizen or permanent resident of the United States.\n\nExclusion Criteria:\n\n1. Current use of smoking cessation pharmacotherapy or nicotine replacement therapy;\n2. Pregnant, planning to become pregnant, or currently breastfeeding;\n3. Past or current clinically significant heart disease or hypertension, or other smoking-related disease that could preclude successful study completion;\n4. Inability to abstain from nicotine/tobacco products for at least 12 hours\n5. Unwillingness to use the research cigarillos in the lab'}, 'identificationModule': {'nctId': 'NCT07162935', 'acronym': 'Clarity', 'briefTitle': 'Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Addiction Potential, Flavoring Content, and Substitutability of Concept Flavored Cigarillos', 'orgStudyIdInfo': {'id': 'Clarity'}, 'secondaryIdInfos': [{'id': 'R01DA062632-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DA062632-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concept flavor', 'description': 'Participants will be randomized to smoke one of the three assigned concept flavored cigarillos', 'interventionNames': ['Other: Cigarillo brand 1', 'Other: Cigarillo brand 2', 'Other: Cigarillo brand 3']}, {'type': 'EXPERIMENTAL', 'label': 'Characterizing flavor', 'description': 'Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos', 'interventionNames': ['Other: Cigarillo brand 1', 'Other: Cigarillo brand 2', 'Other: Cigarillo brand 3']}, {'type': 'EXPERIMENTAL', 'label': 'Tobacco flavor', 'description': 'Participants will be randomized to smoke a tobacco flavored cigarillo', 'interventionNames': ['Other: Cigarillo brand 1', 'Other: Cigarillo brand 2', 'Other: Cigarillo brand 3']}], 'interventions': [{'name': 'Cigarillo brand 1', 'type': 'OTHER', 'description': 'Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed', 'armGroupLabels': ['Characterizing flavor', 'Concept flavor', 'Tobacco flavor']}, {'name': 'Cigarillo brand 2', 'type': 'OTHER', 'description': 'Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed', 'armGroupLabels': ['Characterizing flavor', 'Concept flavor', 'Tobacco flavor']}, {'name': 'Cigarillo brand 3', 'type': 'OTHER', 'description': 'Participants will be assessed on puffing behavior, subjective effects, and exhaled carbon monoxide when assigned to using one of three cigarillo brands. Additives and ingredients of the cigarillo used will also be assessed', 'armGroupLabels': ['Characterizing flavor', 'Concept flavor', 'Tobacco flavor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'contacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'wvutobaccolab@mail.wvu.edu', 'phone': '304-293-0551'}, {'name': 'Melissa Blank, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'centralContacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'heal-lab@ouhsc.edu', 'phone': '405-271-7759'}], 'overallOfficials': [{'name': 'Amy Cohn, OhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': "The investigative team will meet the data submission and release timeframes specified by the funding agency and policies, as described on NIH's data sharing webpage.", 'ipdSharing': 'YES', 'description': 'Data that are determined to be private (name, address, email address) will be provided under a restricted data use contract to those who demonstrate a valid need and meet the conditions of use'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'West Virginia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}