Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT03826303
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Vaping Ethanol in the Evaluation of Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-10', 'size': 268055, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-11T10:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Direct Effects of Vaping Questionnaire', 'timeFrame': 'Administered after e-cigarette use (at 39 minutes after e-cigarette use)', 'description': 'Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100)'}, {'measure': 'Biphasic Alcohol Effects Scale', 'timeFrame': 'Conducted before and after the e-cigarette is used by the participant (change from baseline at 39 and 54 minutes after e-cigarette use)', 'description': 'Questionnaire that asks participants about effects associated with alcohol use (14 questions, each scored from 0 - 10)'}, {'measure': 'General Labeled Magnitude Scale', 'timeFrame': 'Administered after e-cigarette use (at 39 minutes after e-cigarette use)', 'description': 'Questionnaire that asks participants about flavor sensation, harshness/irritancy, and "throat hit" of the e-cigarette (3 questions, each scored from 0 - 100)'}], 'primaryOutcomes': [{'measure': 'Preliminary breath test for ethanol', 'timeFrame': 'Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 27, 35, 40, 45, and 56 minutes after e-cigarette use)', 'description': 'Initial type of breath test used (gives percent blood alcohol concentration)'}, {'measure': 'Evidentiary breath test for ethanol', 'timeFrame': 'Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 29, 37, 42, 47, and 58 minutes after e-cigarette use)', 'description': 'Secondary type of breath test used (gives percent blood alcohol concentration)'}, {'measure': 'Standard Field Sobriety Test', 'timeFrame': 'Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 30 and 49 minutes after e-cigarette use)', 'description': 'Test used to determine sobriety'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electronic Cigarette Use']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals must be e-cigarette users who are 21-65, willing to provide informed consent, attend the lab sessions as needed. Participants must agree to use designated products according to study protocol.\n\nExclusion Criteria:\n\n* Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.\n* Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.'}, 'identificationModule': {'nctId': 'NCT03826303', 'briefTitle': 'The Impact of Vaping Ethanol in the Evaluation of Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'The Impact of Vaping Ethanol in the Evaluation of Impairment', 'orgStudyIdInfo': {'id': 'HM20015064'}, 'secondaryIdInfos': [{'id': '2018-75-CX-0036', 'type': 'OTHER_GRANT', 'domain': 'Department of Justice'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-cigarette with ethanol, 1 puff', 'interventionNames': ['Other: E-cigarette liquid with ethanol, 1 puff']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'E-cigarette without ethanol, 1 puff', 'interventionNames': ['Other: E-cigarette liquid without ethanol, 1 puff']}, {'type': 'EXPERIMENTAL', 'label': 'E-cigarette with ethanol, 10 puffs', 'interventionNames': ['Other: E-cigarette liquid with ethanol, 10 puffs']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'E-cigarette without ethanol, 10 puffs', 'interventionNames': ['Other: E-cigarette liquid without ethanol, 10 puffs']}], 'interventions': [{'name': 'E-cigarette liquid with ethanol, 1 puff', 'type': 'OTHER', 'description': 'E-cigarette liquid with ethanol, 1 puff', 'armGroupLabels': ['E-cigarette with ethanol, 1 puff']}, {'name': 'E-cigarette liquid without ethanol, 1 puff', 'type': 'OTHER', 'description': 'E-cigarette liquid without ethanol, 1 puff', 'armGroupLabels': ['E-cigarette without ethanol, 1 puff']}, {'name': 'E-cigarette liquid with ethanol, 10 puffs', 'type': 'OTHER', 'description': 'E-cigarette liquid with ethanol, 10 puffs', 'armGroupLabels': ['E-cigarette with ethanol, 10 puffs']}, {'name': 'E-cigarette liquid without ethanol, 10 puffs', 'type': 'OTHER', 'description': 'E-cigarette liquid without ethanol, 10 puffs', 'armGroupLabels': ['E-cigarette without ethanol, 10 puffs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Alison Breland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Justice', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}