The Impact of Vaping Ethanol in the Evaluation of Impairment

NCT ID: NCT03826303

Last Updated: 2022-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-02

Study Completion Date

2022-04-08

Brief Summary

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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.

Detailed Description

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Conditions

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Electronic Cigarette Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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E-cigarette with ethanol, 1 puff

Group Type EXPERIMENTAL

E-cigarette liquid with ethanol, 1 puff

Intervention Type OTHER

E-cigarette liquid with ethanol, 1 puff

E-cigarette without ethanol, 1 puff

Group Type PLACEBO_COMPARATOR

E-cigarette liquid without ethanol, 1 puff

Intervention Type OTHER

E-cigarette liquid without ethanol, 1 puff

E-cigarette with ethanol, 10 puffs

Group Type EXPERIMENTAL

E-cigarette liquid with ethanol, 10 puffs

Intervention Type OTHER

E-cigarette liquid with ethanol, 10 puffs

E-cigarette without ethanol, 10 puffs

Group Type PLACEBO_COMPARATOR

E-cigarette liquid without ethanol, 10 puffs

Intervention Type OTHER

E-cigarette liquid without ethanol, 10 puffs

Interventions

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E-cigarette liquid with ethanol, 1 puff

E-cigarette liquid with ethanol, 1 puff

Intervention Type OTHER

E-cigarette liquid without ethanol, 1 puff

E-cigarette liquid without ethanol, 1 puff

Intervention Type OTHER

E-cigarette liquid with ethanol, 10 puffs

E-cigarette liquid with ethanol, 10 puffs

Intervention Type OTHER

E-cigarette liquid without ethanol, 10 puffs

E-cigarette liquid without ethanol, 10 puffs

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 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: Informed Consent Form

View Document

Other Identifiers

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2018-75-CX-0036

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20015064

Identifier Type: -

Identifier Source: org_study_id

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