Electronic CigarettesNCT05587504
Determination of Liquid Flavor and Nicotine Form Outcomes
A study testing E-cigarette with sweetness type 1 and pronation level 1, E-cigarette with sweetness type 1 and pronation level 2 and E-cigarette with sweetness type 2 and pronation level 1 in people with Electronic Cigarettes, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to find out how different types of electronic cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarettes
- What is being tested?
- E-cigarette with sweetness type 1 and pronation level 1, E-cigarette with sweetness type 1 and pronation level 2 and E-cigarette with sweetness type 2 and pronation level 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to 24 Jul 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy (determined by self-report)
- between the ages of 18-65
- willing to provide informed consent
- use cigarettes, e-cigarettes, or both
- able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
Who cannot join
- women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening
- existence of any condition contraindicated for this study protocol as determined by study leadership
- 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 how different types of electronic cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel.
Read the detailed description
In this study, participants will be asked to do the following:
- After an initial screening visit, visit the Center for the Study of Tobacco Products 4 more times for approximately 3-hour study visits.
- Before each visit, abstain from all tobacco products (cigarettes, e-cigarettes/vapes, cigars, and hookah/waterpipe) for at least 12 hours.
- Allow researcher to take blood pressure readings (with blood pressure cuff on their arm) monitor their heart rate (with a device that attaches to their finger), and allow a nurse to insert an IV catheter into their arm that will stay there for the entire session. This catheter will be used to draw blood periodically (less than 1 tablespoon per sample, 5 samples per visit).
- During each session, participants will respond to several questionnaires to measure how they feel before and after they use an e-cigarette.
- In each session, use an electronic cigarette provided by the study team at two separate times. After using the e-cigarette two times, participants will be offered the opportunity to use their own e-cigarette or cigarette.
- Conditions
- Electronic Cigarettes
- Being tested
- E-cigarette with sweetness type 1 and pronation level 1, E-cigarette with sweetness type 1 and pronation level 2, E-cigarette with sweetness type 2 and pronation level 1, E-cigarette with sweetness type 2 and pronation level 2
- 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 with sweetness type 1 and pronation level 1Other
An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 1.
E-cigarette with sweetness type 1 and pronation level 2Other
An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 2.
E-cigarette with sweetness type 2 and pronation level 1Other
An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 1.
E-cigarette with sweetness type 2 and pronation level 2Other
An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 2.
| Study group | Role | What they receive |
|---|---|---|
| Cigarette and/or e-Cigarette users | Experimental | Each participant will participate in 4 sessions. During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm. Receives: Other: E-cigarette with sweetness type 1 and pronation level 1; Other: E-cigarette with sweetness type 1 and pronation level 2; Other: E-cigarette with sweetness type 2 and pronation level 1; Other: E-cigarette with sweetness type 2 and pronation level 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma nicotine concentration
Blood will be taken multiple times in each session to examine changes in plasma nicotine concentration from baseline to after various e-cigarette or cigarette usage.
Measured: Baseline (approx 90 min after session start) to after final product usage (up to 165 min)
Puff volume
The volume of each puff, in ml, averaged over each product use bout.
Measured: Through the final product use (up to 165 min)
Puff duration
The duration of each puff, in ml, averaged over each product use bout.
Measured: Through the final product use (up to 165 min)
Challenge paradigm latency
The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the time it takes for the participant to pick up the product.
Measured: at the end of the challenge paradigm, approx. 165 min
Challenge paradigm puffs
The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the number of puffs the participant takes.
Measured: at the end of the challenge paradigm, approx. 165 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start21 Jul 2023
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic CigarettesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will participate in 5 sessions. Sessions differ by the tobacco product used (see study arms). The sessions will be ordered by latin-square; however, session order is NOT expected to change any outcomes and order effects are not relevant to the study.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alison Breland, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587504
- Sponsor's protocol ID
- HM20025474
- Other IDs
- U54DA036105
- Status last verified
- Feb 2026
- First submitted
- 17 Oct 2022
- Last updated
- 6 Feb 2026
- Results posted
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Liquid Flavor and Nicotine Form Outcomes
- ClinicalTrials.gov ID
- NCT05587504
- Acronym / sponsor ID
- HM20025474
- Conditions
- Electronic Cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 20 Oct 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.
The purpose of this research study is to find out how different types of electronic cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel.
Detailed description
In this study, participants will be asked to do the following:
- After an initial screening visit, visit the Center for the Study of Tobacco Products 4 more times for approximately 3-hour study visits.
- Before each visit, abstain from all tobacco products (cigarettes, e-cigarettes/vapes, cigars, and hookah/waterpipe) for at least 12 hours.
- Allow researcher to take blood pressure readings (with blood pressure cuff on their arm) monitor their heart rate (with a device that attaches to their finger), and allow a nurse to insert an IV catheter into their arm that will stay there for the entire session. This catheter will be used to draw blood periodically (less than 1 tablespoon per sample, 5 samples per visit).
- During each session, participants will respond to several questionnaires to measure how they feel before and after they use an e-cigarette.
- In each session, use an electronic cigarette provided by the study team at two separate times. After using the e-cigarette two times, participants will be offered the opportunity to use their own e-cigarette or cigarette.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will participate in 5 sessions. Sessions differ by the tobacco product used (see study arms). The sessions will be ordered by latin-square; however, session order is NOT expected to change any outcomes and order effects are not relevant to the study.
| Arm | Type | Receives |
|---|---|---|
| Cigarette and/or e-Cigarette users | Experimental | Other: E-cigarette with sweetness type 1 and pronation level 1, Other: E-cigarette with sweetness type 1 and pronation level 2, Other: E-cigarette with sweetness type 2 and pronation level 1, Other: E-cigarette with sweetness type 2 and pronation level 2Each participant will participate in 4 sessions. During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy (determined by self-report)
- between the ages of 18-65
- willing to provide informed consent
- use cigarettes, e-cigarettes, or both
- able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
Key exclusion criteria (3 listed)
- women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening
- existence of any condition contraindicated for this study protocol as determined by study leadership
- 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 with sweetness type 1 and pronation level 1An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 1. | Other | Cigarette and/or e-Cigarette users |
| E-cigarette with sweetness type 1 and pronation level 2An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 2. | Other | Cigarette and/or e-Cigarette users |
| E-cigarette with sweetness type 2 and pronation level 1An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 1. | Other | Cigarette and/or e-Cigarette users |
| E-cigarette with sweetness type 2 and pronation level 2An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 2. | Other | Cigarette and/or e-Cigarette users |
Primary outcome
Change in plasma nicotine concentration
Time frame: Baseline (approx 90 min after session start) to after final product usage (up to 165 min)
Blood will be taken multiple times in each session to examine changes in plasma nicotine concentration from baseline to after various e-cigarette or cigarette usage.
Puff volume
Time frame: Through the final product use (up to 165 min)
The volume of each puff, in ml, averaged over each product use bout.
Puff duration
Time frame: Through the final product use (up to 165 min)
The duration of each puff, in ml, averaged over each product use bout.
Challenge paradigm latency
Time frame: at the end of the challenge paradigm, approx. 165 min
The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the time it takes for the participant to pick up the product.
Challenge paradigm puffs
Time frame: at the end of the challenge paradigm, approx. 165 min
The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the number of puffs the participant takes.
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 6 Feb 2026.
- 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.
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 with sweetness type 1 and pronation level 1, E-cigarette with sweetness type 1 and pronation level 2 and E-cigarette with sweetness type 2 and pronation level 1 in people with Electronic Cigarettes, 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 3 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 6 Feb 2026. 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.
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 plasma nicotine concentration (time frame: Baseline (approx 90 min after session start) to after final product usage (up to 165 min)). The study lists 5 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 6 Feb 2026.