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

NCT ID: NCT04522973

Last Updated: 2026-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-21

Study Completion Date

2024-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Electronic Cigarette Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group assignment
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Within group four condition comparison

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.

Group Type OTHER

Beverage with ethanol and E-cigarette liquid with ethanol

Intervention Type OTHER

Beverage with ethanol and E-cigarette liquid with ethanol

Beverage with ethanol and E-cigarette liquid without ethanol

Intervention Type OTHER

Beverage with ethanol and E-cigarette liquid without ethanol

Beverage without ethanol and E-cigarette liquid with ethanol

Intervention Type OTHER

Beverage without ethanol and E-cigarette liquid with ethanol

Beverage without ethanol and E-cigarette liquid without ethanol

Intervention Type OTHER

Beverage without ethanol and E-cigarette liquid without ethanol

Interventions

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Beverage with ethanol and E-cigarette liquid with ethanol

Beverage with ethanol and E-cigarette liquid with ethanol

Intervention Type OTHER

Beverage with ethanol and E-cigarette liquid without ethanol

Beverage with ethanol and E-cigarette liquid without ethanol

Intervention Type OTHER

Beverage without ethanol and E-cigarette liquid with ethanol

Beverage without ethanol and E-cigarette liquid with ethanol

Intervention Type OTHER

Beverage without ethanol and E-cigarette liquid without ethanol

Beverage without ethanol and E-cigarette liquid without ethanol

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. Department of Justice

FED

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison Breland, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2019-MU-MU-0007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20018402

Identifier Type: -

Identifier Source: org_study_id

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