Electronic Cigarette Use Clinical Trial
Official title:
The Impact of Vaping Ethanol in the Evaluation of Impairment
Verified date | April 2022 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | April 8, 2022 |
Est. primary completion date | April 8, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening. - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | U.S. Department of Justice |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Direct Effects of Vaping Questionnaire | Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100) | Administered after e-cigarette use (at 39 minutes after e-cigarette use) | |
Other | Biphasic Alcohol Effects Scale | Questionnaire that asks participants about effects associated with alcohol use (14 questions, each scored from 0 - 10) | Conducted before and after the e-cigarette is used by the participant (change from baseline at 39 and 54 minutes after e-cigarette use) | |
Other | General Labeled Magnitude Scale | Questionnaire that asks participants about flavor sensation, harshness/irritancy, and "throat hit" of the e-cigarette (3 questions, each scored from 0 - 100) | Administered after e-cigarette use (at 39 minutes after e-cigarette use) | |
Primary | Preliminary breath test for ethanol | Initial type of breath test used (gives percent blood alcohol concentration) | 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) | |
Primary | Evidentiary breath test for ethanol | Secondary type of breath test used (gives percent blood alcohol concentration) | 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) | |
Primary | Standard Field Sobriety Test | Test used to determine sobriety | 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) |
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