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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-75-CX-0036 | Other Grant/Funding Number | Department of Justice |
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| Name | Class |
|---|---|
| U.S. Department of Justice | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-cigarette with ethanol, 1 puff | Experimental |
| |
| E-cigarette without ethanol, 1 puff | Placebo Comparator |
| |
| E-cigarette with ethanol, 10 puffs | Experimental |
| |
| E-cigarette without ethanol, 10 puffs | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette liquid with ethanol, 1 puff | Other | E-cigarette liquid with ethanol, 1 puff |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Biphasic Alcohol Effects Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Breland, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2021 | Apr 11, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| E-cigarette liquid without ethanol, 1 puff | Other | E-cigarette liquid without ethanol, 1 puff |
|
| E-cigarette liquid with ethanol, 10 puffs | Other | E-cigarette liquid with ethanol, 10 puffs |
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| E-cigarette liquid without ethanol, 10 puffs | Other | E-cigarette liquid without ethanol, 10 puffs |
|
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) |
| 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) |