Electronic Cigarette UseNCT03826303
The Impact of Vaping Ethanol in the Evaluation of Impairment
A study testing E-cigarette liquid with ethanol, 1 puff, E-cigarette liquid without ethanol, 1 puff and E-cigarette liquid with ethanol, 10 puffs in people with Electronic Cigarette Use, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- E-cigarette liquid with ethanol, 1 puff, E-cigarette liquid without ethanol, 1 puff and E-cigarette liquid with ethanol, 10 puffs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2021to 8 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Electronic Cigarette Use
- Being tested
- E-cigarette liquid with ethanol, 1 puff, E-cigarette liquid without ethanol, 1 puff, E-cigarette liquid with ethanol, 10 puffs, E-cigarette liquid without ethanol, 10 puffs
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarette liquid with ethanol, 1 puffOther
E-cigarette liquid with ethanol, 1 puff
E-cigarette liquid without ethanol, 1 puffOther
E-cigarette liquid without ethanol, 1 puff
E-cigarette liquid with ethanol, 10 puffsOther
E-cigarette liquid with ethanol, 10 puffs
E-cigarette liquid without ethanol, 10 puffsOther
E-cigarette liquid without ethanol, 10 puffs
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette with ethanol, 1 puff | Experimental | Not described Receives: Other: E-cigarette liquid with ethanol, 1 puff |
| E-cigarette without ethanol, 1 puff | Placebo comparator | Not described Receives: Other: E-cigarette liquid without ethanol, 1 puff |
| E-cigarette with ethanol, 10 puffs | Experimental | Not described Receives: Other: E-cigarette liquid with ethanol, 10 puffs |
| E-cigarette without ethanol, 10 puffs | Placebo comparator | Not described Receives: Other: E-cigarette liquid without ethanol, 10 puffs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary breath test for ethanol
Initial type of breath test used (gives percent blood alcohol concentration)
Measured: 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)
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start2 Apr 2021
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Responsible party
- Sponsor
- Investigators
- Alison Breland, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826303
- Sponsor's protocol ID
- HM20015064
- Other IDs
- 2018-75-CX-0036
- Status last verified
- Apr 2022
- First submitted
- 30 Jan 2019
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vaping Ethanol in the Evaluation of Impairment
- ClinicalTrials.gov ID
- NCT03826303
- Acronym / sponsor ID
- HM20015064
- Conditions
- Electronic Cigarette Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- U.S. Department of Justice
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigarette liquid with ethanol, 1 puffE-cigarette liquid with ethanol, 1 puff | Other | E-cigarette with ethanol, 1 puff |
| E-cigarette liquid without ethanol, 1 puffE-cigarette liquid without ethanol, 1 puff | Other | E-cigarette without ethanol, 1 puff |
| E-cigarette liquid with ethanol, 10 puffsE-cigarette liquid with ethanol, 10 puffs | Other | E-cigarette with ethanol, 10 puffs |
| E-cigarette liquid without ethanol, 10 puffsE-cigarette liquid without ethanol, 10 puffs | Other | E-cigarette without ethanol, 10 puffs |
Primary outcome
Preliminary breath test for ethanol
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Electronic Cigarette Use
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Breland, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette liquid with ethanol, 1 puff, E-cigarette liquid without ethanol, 1 puff and E-cigarette liquid with ethanol, 10 puffs in people with Electronic Cigarette Use, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary breath test for ethanol (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.