E-Cig UseEarly Phase 1NCT05199480
Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health
A Early Phase 1 study testing Tobacco flavored liquid type 1 and Tobacco flavored liquid type 2 in people with E-Cig Use, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- E-Cig Use
- What is being tested?
- Tobacco flavored liquid type 1 and Tobacco flavored liquid type 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 30 Jul 2024
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- E-Cigarette group:
- 21 years of age or older
- Used e-cigarettes (≥3 times/week for ≥3 months)
- Non e-cigarette group
- ● 21 years of age or older
Who cannot join
- 20 years old and younger
- Use of cigarettes for 15 days or more in the past 60 days
- Use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days
- Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days
- Known allergy to propylene glycol or vegetable glycerin
- Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, or cerebral diseases
- Disorder or use of medication that affects cardiopulmonary health
- Evidence of pregnancy or current nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health
- Conditions
- E-Cig Use
- Being tested
- Tobacco flavored liquid type 1, Tobacco flavored liquid type 2
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco flavored liquid type 1Drug
A commercially available cartridge-based device with tobacco flavored liquid.
Tobacco flavored liquid type 2Drug
A commercially available cartridge-based device with tobacco flavored liquid.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette liquid type 1 | Experimental | Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period. Receives: Drug: Tobacco flavored liquid type 1 |
| E-cigarettes liquid type 2 | Active comparator | Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period. Receives: Drug: Tobacco flavored liquid type 2 |
| No e-cigarettes | No intervention | No e-cigarette use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak oxygen consumption (VO2 peak)
Participants' peak oxygen consumption (VO2 peak) will be measured using a standardized exercise capacity test performed on a stationary bike.
Measured: Change from baseline to 2 weeks
Change in Expiratory Volume
Participants expiratory volume will be measured through spirometry using a pulmonary function device.
Measured: Change from baseline to 2 weeks
Secondary outcomes (2)
Change in Skeletal muscle O2 utilization
Assessment of skeletal muscle oxygen utilization using near-infrared spectroscopy through the ratio of O2 delivery and O2 extraction
Measured: Change from baseline to 2 weeks
Change in Maximal microvascular dilation
Participants' microvascular function (maximal dilation) will be measured using local thermal hyperemia.
Measured: Change from baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start10 Jan 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-Cig 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Rodriguez Miguelez, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199480
- Sponsor's protocol ID
- HM20022776
- Status last verified
- Jun 2025
- First submitted
- 16 Dec 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health
- ClinicalTrials.gov ID
- NCT05199480
- Acronym / sponsor ID
- HM20022776
- Conditions
- E-Cig Use
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 20 Jan 2022 (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.
Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E-cigarette liquid type 1 | Experimental | Drug: Tobacco flavored liquid type 1Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period. |
| E-cigarettes liquid type 2 | Active comparator | Drug: Tobacco flavored liquid type 2Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period. |
| No e-cigarettes | No intervention | –No e-cigarette use |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 years of age or older
- Used e-cigarettes (≥3 times/week for ≥3 months)
- Non e-cigarette group
- ● 21 years of age or older
Key exclusion criteria (8 listed)
- 20 years old and younger
- Use of cigarettes for 15 days or more in the past 60 days
- Use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days
- Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days
- Known allergy to propylene glycol or vegetable glycerin
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 |
|---|---|---|
| Tobacco flavored liquid type 1A commercially available cartridge-based device with tobacco flavored liquid. | Drug | E-cigarette liquid type 1 |
| Tobacco flavored liquid type 2A commercially available cartridge-based device with tobacco flavored liquid. | Drug | E-cigarettes liquid type 2 |
Primary outcome
Change in Peak oxygen consumption (VO2 peak)
Time frame: Change from baseline to 2 weeks
Participants' peak oxygen consumption (VO2 peak) will be measured using a standardized exercise capacity test performed on a stationary bike.
Change in Expiratory Volume
Time frame: Change from baseline to 2 weeks
Participants expiratory volume will be measured through spirometry using a pulmonary function device.
2 secondary outcomes
Change in Skeletal muscle O2 utilization
Time frame: Change from baseline to 2 weeks
Change in Maximal microvascular dilation
Time frame: Change from baseline to 2 weeks
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 1 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Paula Rodriguez Miguelez, 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 Early Phase 1 study testing Tobacco flavored liquid type 1 and Tobacco flavored liquid type 2 in people with E-Cig 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 5 inclusion and 8 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 1 Jul 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Peak oxygen consumption (VO2 peak) (time frame: Change from baseline to 2 weeks). The study lists 2 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 1 Jul 2025.