Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-05 @ 6:09 PM
Study NCT ID:
NCT06668350
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attitudes and Perceptions Attitudes and Smoking Perceptions in the Real Environment -II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Puff volume', 'timeFrame': 'From enrollment to the end of the study at 6 weeks', 'description': 'Volume of inhaled cigarillo puffs'}, {'measure': 'Subjective effects from smoking', 'timeFrame': 'From enrollment to the end of the study at 6 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.'}, {'measure': 'Exhaled carbon monoxide', 'timeFrame': 'From enrollment to the end of the study at 6 weeks', 'description': 'Changes in exhaled carbon monoxide (CO boot) following cigarillo smoking'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cigarillo Flavor']}, 'descriptionModule': {'briefSummary': 'This multi-method project will recruit young adults who currently use cigarillos and examine the effects of different flavored cigarillo types (concept, characterizing, tobacco) on three measures of tobacco product appeal: subjective effects (e.g., taste, enjoyment, satisfaction, reward), actual smoking behavior (e.g., number of puffs), and tobacco product purchases via a simulated experimental tobacco marketplace.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages18 to 34\n* Smoke a little cigar or cigarillo (LCCs) "some days" or "everyday" (verified by brand name of the product);\n* Ability to read English at an 8th grade level or higher; and\n* No immediate plans to quit using tobacco\n* \\> 1 prior experience, even 1 puff, with a flavored tobacco product\n* U.S. Citizen or permanent resident of the United States.\n\nExclusion Criteria:\n\n* Current use of nicotine replacement therapy (NRT) or stop smoking medication;\n* Pregnant, planning to become pregnant, or currently breastfeeding;\n* Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion;\n* Inability to abstain from nicotine/tobacco products for at least 12 hours prior to lab sessions\n* Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)\n* Unwillingness to use "untipped" (e.g., plastic or wood tip) little cigars/cigarillos.'}, 'identificationModule': {'nctId': 'NCT06668350', 'acronym': 'ASPIRE-II', 'briefTitle': 'Attitudes and Perceptions Attitudes and Smoking Perceptions in the Real Environment -II', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Racial/Ethnic Differences in Appeal and Preference for Flavored Little Cigars/Cigarillos: A Multi-Method Approach to Inform Tobacco Policy', 'orgStudyIdInfo': {'id': 'ACS CHERC'}, 'secondaryIdInfos': [{'id': 'CHERC-24-1160021-01-CHERC', 'type': 'OTHER_GRANT', 'domain': 'American Cancer Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concept flavored cigarillo', 'description': 'Participants will smoke a concept flavored cigarillo in the lab', 'interventionNames': ['Other: Smoking outcomes']}, {'type': 'EXPERIMENTAL', 'label': 'Characterizing flavored cigarillo', 'description': 'Participants will smoke a characterizing flavored cigarillo', 'interventionNames': ['Other: Smoking outcomes']}, {'type': 'EXPERIMENTAL', 'label': 'Tobacco flavored cigarillo', 'description': 'Participants will smoke a tobacco flavored cigarillo', 'interventionNames': ['Other: Smoking outcomes']}], 'interventions': [{'name': 'Smoking outcomes', 'type': 'OTHER', 'description': 'Participants will be assessed on several smoking outcomes including puffing behavior, subjective effects, and exhaled carbon monoxide', 'armGroupLabels': ['Characterizing flavored cigarillo', 'Concept flavored cigarillo', 'Tobacco flavored cigarillo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73012', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'heal-lab@ouhsc.edu', 'phone': '405-271-1903'}, {'name': 'Amy Cohn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'TSET Health Promotion Research Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'centralContacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'heal-lab@ouhsc.edu', 'phone': '1-405-271-7759'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}