The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Electronic Cigarette Use

Treatments: Other: Beverage with ethanol and E-cigarette liquid without ethanol; Other: Beverage without ethanol and E-cigarette liquid with ethanol; Other: Beverage with ethanol and E-cigarette liquid with ethanol; Other: Beverage without ethanol and E-cigarette liquid without ethanol

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04522973

2019-MU-MU-0007 (Other Grant/Funding Number)

HM20018402

Details and patient eligibility

About

The purpose of this research study is to determine if ethanol-containing e-cigarettes impact ethanol breath, blood or oral fluid tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.

Enrollment: 12 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• e-cigarette users
• alcohol consumers
• willing to provide informed consent
• able to attend the lab sessions as needed
• agree to use designated products according to study protocol.

Exclusion criteria

- Women who are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Within group four condition comparison

Other group

Description:

Participants completed four \~5-hour, Latin-square ordered sessions separated by ≥48 hours. Session order was not recorded as it was not relevant to the study outcomes: Beverage with ethanol and E-cigarette liquid with ethanol, Beverage with ethanol and E-cigarette liquid without ethanol, Beverage without ethanol and E-cigarette liquid with ethanol, and Beverage without ethanol and E-cigarette liquid without ethanol.

Treatment:

Other: Beverage without ethanol and E-cigarette liquid without ethanol

Other: Beverage with ethanol and E-cigarette liquid with ethanol

Other: Beverage without ethanol and E-cigarette liquid with ethanol

Other: Beverage with ethanol and E-cigarette liquid without ethanol