Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-26 @ 9:16 PM
Study NCT ID:
NCT05958966
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 - 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-01', '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': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Appeal Rating Questionnaire', 'timeFrame': '1 hour', 'description': 'This self-report measure of 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 Rating Questionnaire', 'timeFrame': '1 hour', 'description': 'This self-report measure 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': 'Smoking Delay Task', 'timeFrame': '1 hour', 'description': 'Minutes delayed before purchasing time to smoke own cigarettes. Scores can range from 0mins to 50mins for the smoking delay task, with lower scores representing fewer minutes delayed from smoking and higher scores representing longer minutes delayed from smoking.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electronic Cigarette Use', 'E-Cig Use', 'Cigarette Smoking', 'Cigarette Use, Electronic']}, 'descriptionModule': {'briefSummary': 'This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. 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. For this substudy, adult smokers (N=200) will attend two laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, nicotine formulation) and smoke their own cigarettes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regular use of cigarettes containing nicotine.\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT05958966', 'briefTitle': 'Effects of e-Cigarettes on Perceptions and Behavior - Substudy 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Effects of e-Cigarettes on Perceptions and Behavior - Substudy 2', 'orgStudyIdInfo': {'id': 'HS-18-00839 Substudy 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-cigarette e-liquid 1', 'description': 'Participants will self-administer an e-cigarette e-liquid.', 'interventionNames': ['Other: E-cigarette e-liquid self-administration']}, {'type': 'EXPERIMENTAL', 'label': 'E-cigarette e-liquid 2', 'description': 'Participants will self-administer an e-cigarette e-liquid.', 'interventionNames': ['Other: E-cigarette e-liquid self-administration']}, {'type': 'EXPERIMENTAL', 'label': 'E-cigarette e-liquid 3', 'description': 'Participants will self-administer an e-cigarette e-liquid.', 'interventionNames': ['Other: E-cigarette e-liquid self-administration']}, {'type': 'EXPERIMENTAL', 'label': 'E-cigarette e-liquid 4', 'description': 'Participants will self-administer an e-cigarette e-liquid.', 'interventionNames': ['Other: E-cigarette e-liquid self-administration']}, {'type': 'NO_INTERVENTION', 'label': 'No e-liquid', 'description': 'Participants do not receive an e-cigarette e-liquid to self-administer.'}], 'interventions': [{'name': 'E-cigarette e-liquid self-administration', 'type': 'OTHER', 'description': 'Participant will self-administer an experimenter-provided e-cigarette.', 'armGroupLabels': ['E-cigarette e-liquid 1', 'E-cigarette e-liquid 2', 'E-cigarette e-liquid 3', 'E-cigarette 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, Department of Preventive Medicine', 'investigatorFullName': 'Adam Leventhal', 'investigatorAffiliation': 'University of Southern California'}}}}