Electronic Nicotine Delivery System FlavorsRVA FlavorsNCT05023096
Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers
A study testing Tobacco product administration and assessment in people with Electronic Nicotine Delivery System Flavors, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study aims to better understand how the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electronic Nicotine Delivery System Flavors
- What is being tested?
- Tobacco product administration and assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 21+ years of age
- identify as Black/African American (single or multi-race)
- have used ≥5 cigarettes per day for ≥1 year
- biochemically confirmed cigarette smoking status
- regular cigarette brand is flavored to taste like menthol or mint
- ENDS use in the past 3 months
Show all 11Show fewer
- report no intent to quit smoking in the next 6 months
- previous quit attempt using evidence-based method
- have a working mobile phone with a texting/data plan
- are willing receive phone calls/text messages and complete internet-based/online surveys related to the study.
- read and write in English
Who cannot join
- are unwilling to use ENDS as part of the trial
- unstable or significant medical condition in the past 12 months
- report any other illegal drug use in past 30 days
- report intent to become pregnant or current pregnancy/breastfeeding
- report any other condition that may affect participant safety or not allow them to fully participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Effects of Electronic Nicotine Delivery System Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability Among African American Menthol Smokers (RVA Flavors)
This study aims to better understand how the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers.
Read the detailed description
Black/African American (AA) menthol smokers are disproportionately harmed by tobacco products and could experience significant health benefits from increased availability of well-regulated electronic nicotine delivery systems (ENDS). The current study will evaluate whether ENDS flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers by performing a 3-arm, 6-week clinical trial of ENDS provision with follow-up to 30 days. Results of this work will help FDA make predictions about the impact of moving from the current regulatory market were menthol/tobacco flavored ENDS cartridges are available, to one where only tobacco or unflavored cartridges are available, in order to maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.
- Being tested
- Tobacco product administration and assessment
- Keywords
- Electronic Nicotine Delivery System, Electronic Cigarette, Flavor, Abuse Liability, Toxicant Exposure, Tobacco, African American, Menthol
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco product administration and assessmentOther
Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Menthol+Tobacco | Active comparator | Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from Receives: Other: Tobacco product administration and assessment |
| Tobacco | Experimental | Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems Receives: Other: Tobacco product administration and assessment |
| Unflavored | Experimental | Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems Receives: Other: Tobacco product administration and assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Cigarette Use
Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Measured: Randomization and Week 6
Carbon Monoxide Exposure
A biomarker of combusted cigarette use collected from exhaled breath.
Measured: Randomization and Week 6
Willingness to Substitute From Cigarettes to ENDS
CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios involving their own brand cigarettes and condition-specific ENDS. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a their conditions-specific ENDS they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each ENDS puff cost $0.10. The outcome of the task is the willingness to pay in USD for each ENDS puff.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start14 Apr 2022
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Electronic Nicotine Delivery System FlavorsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 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
- Andrew J Barnes, PhD, Principal investigator, Virginia Commonwealth UniversityCaroline O Cobb, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023096
- Sponsor's protocol ID
- HM20022060
- Other IDs
- 1R01DA050996-01A1
- Acronym
- RVA Flavors
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2021
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electronic Nicotine Delivery System Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability Among African American Menthol Smokers (RVA Flavors)
- ClinicalTrials.gov ID
- NCT05023096
- Acronym / sponsor ID
- RVA Flavors / HM20022060
- Keywords
- Electronic Nicotine Delivery System, Electronic Cigarette, Flavor, Abuse Liability, Toxicant Exposure, Tobacco, African American, Menthol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 22 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to better understand how the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers.
Detailed description
Black/African American (AA) menthol smokers are disproportionately harmed by tobacco products and could experience significant health benefits from increased availability of well-regulated electronic nicotine delivery systems (ENDS). The current study will evaluate whether ENDS flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers by performing a 3-arm, 6-week clinical trial of ENDS provision with follow-up to 30 days. Results of this work will help FDA make predictions about the impact of moving from the current regulatory market were menthol/tobacco flavored ENDS cartridges are available, to one where only tobacco or unflavored cartridges are available, in order to maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menthol+Tobacco | Active comparator | Other: Tobacco product administration and assessmentMenthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from |
| Tobacco | Experimental | Other: Tobacco product administration and assessmentTobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems |
| Unflavored | Experimental | Other: Tobacco product administration and assessmentUnflavored - where only unflavored liquid is available for electronic nicotine delivery systems |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 21+ years of age
- identify as Black/African American (single or multi-race)
- have used ≥5 cigarettes per day for ≥1 year
- biochemically confirmed cigarette smoking status
- regular cigarette brand is flavored to taste like menthol or mint
Key exclusion criteria (5 listed)
- are unwilling to use ENDS as part of the trial
- unstable or significant medical condition in the past 12 months
- report any other illegal drug use in past 30 days
- report intent to become pregnant or current pregnancy/breastfeeding
- report any other condition that may affect participant safety or not allow them to fully participate in 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 |
|---|---|---|
| Tobacco product administration and assessmentParticipants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks. | Other | Menthol+Tobacco, Tobacco, Unflavored |
Primary outcome
Average Daily Cigarette Use
Time frame: Randomization and Week 6
Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Carbon Monoxide Exposure
Time frame: Randomization and Week 6
A biomarker of combusted cigarette use collected from exhaled breath.
Willingness to Substitute From Cigarettes to ENDS
Time frame: Week 6
CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios involving their own brand cigarettes and condition-specific ENDS. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a their conditions-specific ENDS they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each ENDS puff cost $0.10. The outcome of the task is the willingness to pay in USD for each ENDS puff.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Electronic Nicotine Delivery System Flavors
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Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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Recruiting
A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System
Smoking, Tobacco
Not yet recruiting
Flavored Ready-to-Drink Alcohol Restriction in Young Adults: Behavioral and Biomarker Outcomes
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A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers
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Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine
Tobacco-flavored EC, Sweet-Cooling EC
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.
Andrew J Barnes, PhD principal investigator
Virginia Commonwealth University
Caroline O Cobb, 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 Tobacco product administration and assessment in people with Electronic Nicotine Delivery System Flavors, 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 11 inclusion and 5 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 22 Apr 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?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Daily Cigarette Use (time frame: Randomization and Week 6). 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 22 Apr 2026.