The Impact of Vaping Ethanol in the Evaluation of Impairment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E-cigarette with ethanol, 1 puff
|
Other: E-cigarette liquid with ethanol, 1 puff
E-cigarette liquid with ethanol, 1 puff
|
| Placebo Comparator: E-cigarette without ethanol, 1 puff
|
Other: E-cigarette liquid without ethanol, 1 puff
E-cigarette liquid without ethanol, 1 puff
|
| Experimental: E-cigarette with ethanol, 10 puffs
|
Other: E-cigarette liquid with ethanol, 10 puffs
E-cigarette liquid with ethanol, 10 puffs
|
| Placebo Comparator: E-cigarette without ethanol, 10 puffs
|
Other: E-cigarette liquid without ethanol, 10 puffs
E-cigarette liquid without ethanol, 10 puffs
|
Outcome Measures
Primary Outcome Measures
- Preliminary breath test for ethanol [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)]
Initial type of breath test used (gives percent blood alcohol concentration)
- Evidentiary breath test for ethanol [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)]
Secondary type of breath test used (gives percent blood alcohol concentration)
- Standard Field Sobriety Test [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)]
Test used to determine sobriety
Other Outcome Measures
- Direct Effects of Vaping Questionnaire [Administered after e-cigarette use (at 39 minutes after e-cigarette use)]
Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100)
- Biphasic Alcohol Effects Scale [Conducted before and after the e-cigarette is used by the participant (change from baseline at 39 and 54 minutes after e-cigarette use)]
Questionnaire that asks participants about effects associated with alcohol use (14 questions, each scored from 0 - 10)
- General Labeled Magnitude Scale [Administered after e-cigarette use (at 39 minutes after e-cigarette use)]
Questionnaire that asks participants about flavor sensation, harshness/irritancy, and "throat hit" of the e-cigarette (3 questions, each scored from 0 - 100)
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- U.S. Department of Justice
Investigators
- Principal Investigator: Alison Breland, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
More Information
Publications
None provided.- HM20015064
- 2018-75-CX-0036