NCT03826303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 2, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

January 30, 2019

Last Update Submit

April 11, 2022

Conditions

Electronic Cigarette Use

Outcome Measures

Primary Outcomes (3)

  • 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)

Other Outcomes (3)

  • Direct Effects of Vaping Questionnaire

    Administered after e-cigarette use (at 39 minutes after e-cigarette use)

  • 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)

  • General Labeled Magnitude Scale

    Administered after e-cigarette use (at 39 minutes after e-cigarette use)

Study Arms (4)

E-cigarette with ethanol, 1 puff

EXPERIMENTAL
Other: E-cigarette liquid with ethanol, 1 puff

E-cigarette without ethanol, 1 puff

PLACEBO COMPARATOR
Other: E-cigarette liquid without ethanol, 1 puff

E-cigarette with ethanol, 10 puffs

EXPERIMENTAL
Other: E-cigarette liquid with ethanol, 10 puffs

E-cigarette without ethanol, 10 puffs

PLACEBO COMPARATOR
Other: E-cigarette liquid without ethanol, 10 puffs

Interventions

E-cigarette liquid with ethanol, 1 puffOTHER

E-cigarette liquid with ethanol, 1 puff

E-cigarette with ethanol, 1 puff
E-cigarette liquid without ethanol, 1 puffOTHER

E-cigarette liquid without ethanol, 1 puff

E-cigarette without ethanol, 1 puff
E-cigarette liquid with ethanol, 10 puffsOTHER

E-cigarette liquid with ethanol, 10 puffs

E-cigarette with ethanol, 10 puffs
E-cigarette liquid without ethanol, 10 puffsOTHER

E-cigarette liquid without ethanol, 10 puffs

E-cigarette without ethanol, 10 puffs

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Ethanol

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Alison Breland, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

April 2, 2021

Primary Completion

April 8, 2022

Study Completion

April 8, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)