Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 11:38 PM
Study NCT ID:
NCT05949034
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2019-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of E-Cigarettes in Menthol Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preference Ratings', 'timeFrame': '1 hour', 'description': 'Self-report measures of product preference will be completed following the e-cigarette self-administration. Scores can range from 0 to 100 for the preference rating, with lower scores representing less preference and higher scores representing higher preference.'}, {'measure': 'Mood - Positive Affect Negative Affect Schedule', 'timeFrame': '4 hours', 'description': 'This measure is obtained through the completion of the Positive Affect Negative Affect Schedule. A total score will be calculated for both Positive and Negative Affect. Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.'}, {'measure': 'Mood - Profile of Mood States', 'timeFrame': '4 hours', 'description': 'This measure is obtained through the completion of the Profile of Mood States. A total score will be calculated. Scores can range from 10 to 260, with the lower scores representing lower levels of mood disturbance and higher scores representing higher levels of mood disturbance.'}, {'measure': 'Cigarette Craving', 'timeFrame': '4 hours', 'description': 'This measure is obtained through the completion of the Brief Questionnaire of Smoking Urges. A total score will be calculated. Scores can range from 10 to 70, with the lower scores representing a lower level of cigarette craving and higher scores representing greater levels of cigarette craving.'}, {'measure': 'Nicotine Withdrawal - Minnesota Nicotine Withdrawal Scale', 'timeFrame': '4 hours', 'description': 'This measure is obtained through the completion of the Minnesota Nicotine Withdrawal Scale. A total score will be calculated. Scores can range from 0 to 32, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal.'}, {'measure': 'Nicotine Withdrawal - Wisconsin Smoking Withdrawal Scale', 'timeFrame': '4 hours', 'description': 'This measure is obtained through the completion of the Wisconsin Smoking Withdrawal Scale. A total score will be calculated. Scores can range from 0 to 112, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal.'}, {'measure': 'Smoking Motivation', 'timeFrame': '2 hours after experimental session outset', 'description': 'This measure is obtained through the completion of a computerized behavioral task.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menthol', 'cigarette', 'smoking'], 'conditions': ['E-cigarette Use', 'Smoking Behaviors']}, 'descriptionModule': {'briefSummary': 'The current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Daily cigarette smoking for at least the past 2 years\n* Interest in trying e-cigarettes\n* Report smoking mentholated cigarettes\n\nExclusion Criteria:\n\n\\-- Pregnancy and/or breastfeeding'}, 'identificationModule': {'nctId': 'NCT05949034', 'briefTitle': 'Effects of E-Cigarettes in Menthol Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Effects of E-Cigarettes in Menthol Smokers', 'orgStudyIdInfo': {'id': 'HS-19-00325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-Cigarette Flavor 1 Condition', 'description': 'Participants will self-administer a flavored e-cigarette.', 'interventionNames': ['Device: JUUL E-Cigarette Device']}, {'type': 'EXPERIMENTAL', 'label': 'E-Cigarette Flavor 2 Condition', 'description': 'Participants will self-administer a flavored e-cigarette.', 'interventionNames': ['Device: JUUL E-Cigarette Device']}, {'type': 'EXPERIMENTAL', 'label': 'E-Cigarette Flavor 3 Condition', 'description': 'Participants will self-administer a flavored e-cigarette.', 'interventionNames': ['Device: JUUL E-Cigarette Device']}], 'interventions': [{'name': 'JUUL E-Cigarette Device', 'type': 'DEVICE', 'description': 'We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.', 'armGroupLabels': ['E-Cigarette Flavor 1 Condition', 'E-Cigarette Flavor 2 Condition', 'E-Cigarette Flavor 3 Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Adam Leventhal, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Adam Leventhal', 'investigatorAffiliation': 'University of Southern California'}}}}