Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT05958992
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2023-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D066300', 'term': 'Electronic Nicotine Delivery Systems'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to use an e-liquid'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 461}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2023-07-14', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Appeal', 'timeFrame': '1 hour', 'description': 'This self-report measures of subjective product appeal will be completed following e-cigarette self-administration. Scores can range from 0 to 100 for the appeal rating, with lower scores representing lower levels of appeal and higher scores representing higher levels of appeal.'}, {'measure': 'Sensory Attributes', 'timeFrame': '1 hour', 'description': 'This self-report measures of product sensory attributes will be completed following e-cigarette self-administration. Scores can range from 0 to 100 for the sensory attribute rating, with lower scores representing lower levels of liking the sensory attribute and higher scores representing greater liking of the sensory attribute.'}, {'measure': 'Vaping Delay', 'timeFrame': '1 hour', 'description': 'Minutes delayed before purchasing time to vape an e-liquid.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaping', 'e-cigarette', 'vape', 'nicotine', 'tobacco'], 'conditions': ['Electronic Cigarette Use', 'Cigarette Smoking', 'Cigarette Use, Electronic', 'Vaping']}, 'descriptionModule': {'briefSummary': 'This study assess the ways in which e-cigarette product characteristics, such as flavors and nicotine salts, impact user experience to inform potential regulations.', 'detailedDescription': 'There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVapers/E-cigarette Users - Regular use of e-cigarettes/vaping devices containing nicotine\n\nCigarette Smokers\n\n\\- Regular use of cigarettes containing nicotine\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT05958992', 'briefTitle': 'Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 2', 'orgStudyIdInfo': {'id': 'Substudy #2: UP-20-00744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-Liquid 1', 'description': 'Participants will self-administer an assigned e-liquid.', 'interventionNames': ['Other: E-cigarette']}, {'type': 'EXPERIMENTAL', 'label': 'E-Liquid 2', 'description': 'Participants will self-administer an assigned e-liquid.', 'interventionNames': ['Other: E-cigarette']}, {'type': 'EXPERIMENTAL', 'label': 'E-liquid 3', 'description': 'Participants will self-administer an assigned e-liquid.', 'interventionNames': ['Other: E-cigarette']}, {'type': 'EXPERIMENTAL', 'label': 'E-liquid 4', 'description': 'Participants will self-administer an assigned e-liquid.', 'interventionNames': ['Other: E-cigarette']}, {'type': 'NO_INTERVENTION', 'label': 'No e-liquid', 'description': 'Participants will not receive an e-liquid to self-administer.'}], 'interventions': [{'name': 'E-cigarette', 'type': 'OTHER', 'description': 'Participants will self-administer experimenter-provided e-cigarettes', 'armGroupLabels': ['E-Liquid 1', 'E-Liquid 2', 'E-liquid 3', 'E-liquid 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Preventive Medicine', 'investigatorFullName': 'Adam Leventhal', 'investigatorAffiliation': 'University of Southern California'}}}}