Cigarette SmokingNCT04879225

Menthol and Mint Experimental Tobacco Marketplace (ETM) Study

A study testing Tobacco e-liquids, Menthol and Tobacco e-liquids and Mint, Menthol and Tobacco e-liquids in people with Cigarette Smoking and Vaping, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Cigarette Smoking, Vaping
What is being tested?: Tobacco e-liquids, Menthol and Tobacco e-liquids and Mint, Menthol and Tobacco e-liquids
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 21 Jun 2021to 29 Dec 2022
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
Self-report smoking at least 5 cigarettes per day for the past year
Self-report smoking menthol cigarette brands > 80% of the time
Breathe carbon monoxide (CO) level > 8 ppm Willingness to use other tobacco products during the study
Speak, comprehend, and read English sufficiently to complete study procedures
Have home access to a computer or tablet with a web camera and internet access

Who cannot join

Currently seeking treatment to quit smoking
Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
Body temperature > 100.4 F
Cold, flu or Novel Coronavirus (COVID-19) symptoms including fever, cough, and runny nose in the past 30 days
Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy
CO reading > 80 ppm
Enrollment stratum (Non-Hispanic, white or Black/African American)

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: The Impact of Menthol and Mint E-liquid Bans on Menthol Cigarette Smokers

Menthol cigarettes comprise almost one-third of the United States (US) market share and are disproportionately smoked by racial minorities. Tobacco control policies targeting menthol flavoring in tobacco could have significant public health outcomes, especially among black smokers. One key challenge of tobacco regulation is weighing the risks and benefits of potential policies across different populations (i.e., users and non-users). Tension arises between policies intended to prevent adolescent and young adult (AYA) tobacco initiation and those intended to reduce harm among current tobacco users. The availability of menthol e-liquids may be important for encouraging menthol cigarette smokers to switch to e- cigarettes, but mint e-liquids, which are appealing to AYA, may be unnecessary to facilitate switching. Including mint e-liquids in flavor bans but allowing menthol e-liquids to remain on the market as potential substitution products for menthol smokers may be an optimal policy approach. The study team is proposing a lab study and field assessment to determine how including menthol and mint e-liquids in e-liquid flavor bans or sales restrictions affects tobacco product purchasing and use among menthol cigarette smokers. At lab sessions, participants will complete the Experimental Tobacco Marketplace (ETM) task, a behavioral economics task in which they receive account balances to an online store and can buy menthol cigarettes at escalating costs or buy e-liquids, non-menthol cigarettes, or nicotine replacement gum at fixed costs. They will complete the task under four marketplace conditions: (1) only tobacco e-liquids available, (2) menthol and tobacco e-liquids available, (3) menthol, mint, and tobacco e-liquids available, and (4) tobacco, menthol, mint, fruit, dessert. During a field assessment, product choice is validated by assessing use of products purchased during the ETM task. This proposal will inform policy-makers about the impact banning menthol and mint e-liquids will have on facilitating menthol cigarette smokers switching to e-cigarettes.

Read the detailed description

The study team proposes to conduct a within-subjects, multi-session virtual lab study and validation field assessment to determine how the availability of menthol and mint e-liquids affects product purchasing among menthol cigarette smokers. Adult daily menthol cigarette smokers will be recruited for this study. After initial eligibility is assessed, participants will complete six virtual sessions and one field assessment to evaluate their tobacco use.

Participants will be recruited from Winston-Salem, North Carolina (NC) and the surrounding area using advertisements on public transit, community flyers, and social media. Curbside visits to drop off biosamples and pickup study products will be conducted outside the Wake Forest Tobacco Control Center of Excellence located in Biotech Place in the Innovation Quarter.

The study team anticipates recruiting up to 100 participants to achieve 80 completers. Equal numbers of black and white participants will be enrolled.

Conditions: Cigarette Smoking, Vaping
Being tested: Tobacco e-liquids, Menthol and Tobacco e-liquids, Mint, Menthol and Tobacco e-liquids, All e-liquid flavors
Keywords: smoking, menthol, mint, vaping, menthol ban
Medical subject headings: Cigarette Smoking, Vaping, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tobacco e-liquidsBehavioural
Marketplace includes tobacco flavored e-liquids
Menthol and Tobacco e-liquidsBehavioural
Marketplace includes menthol and tobacco flavored e-liquids
Mint, Menthol and Tobacco e-liquidsBehavioural
Marketplace includes mint, menthol and tobacco flavored e-liquids
All e-liquid flavorsBehavioural
Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids

Study groups in NCT04879225
Study group	Role	What they receive
Intervention 1: Fruit, dessert, mint, menthol, tobacco	Experimental	All participants receive all interventional e-liquid flavors on separate days. Receives: Behavioral: All e-liquid flavors
Intervention 2: Mint, menthol, and tobacco	Experimental	All participants receive all interventional e-liquid flavors on separate days. Receives: Behavioral: Mint, Menthol and Tobacco e-liquids
Intervention 3: Menthol and Tobacco	Experimental	All participants receive all interventional e-liquid flavors on separate days. Receives: Behavioral: Menthol and Tobacco e-liquids
Intervention 4: Only tobacco	Experimental	All participants receive all interventional e-liquid flavors on separate days. Receives: Behavioral: Tobacco e-liquids

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Amount of Combusted Tobacco Purchased
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Measured: Day 3
Total Amount of Combusted Tobacco Purchased
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Measured: Day 4
Total Amount of Combusted Tobacco Purchased
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Measured: Day 5
Total Amount of Combusted Tobacco Purchased
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Measured: Day 6

Secondary outcomes (1)

Total Amount of E-liquid Purchased
Total amount of e-liquid purchased when menthol cigarettes are not available.
Measured: Day 3, Day 4, Day 5, Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 202129 Dec 2022

First posted10 May 2021
Study start21 Jun 2021
Primary completion29 Dec 2022
Study completion29 Dec 2022

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 Cigarette SmokingStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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: Other
Allocation: Non-randomised
Intervention model: Sequential
Model description: Participants will experience four marketplace conditions that differ in the availability of flavored e-liquids.
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04879225
Sponsor's protocol ID: IRB00065077
Status last verified: Apr 2022
First submitted: 13 Apr 2021
Last updated: 26 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Menthol and Mint E-liquid Bans on Menthol Cigarette Smokers
ClinicalTrials.gov ID: NCT04879225
Acronym / sponsor ID: IRB00065077
Conditions: Cigarette Smoking, Vaping
Keywords: smoking, menthol, mint, vaping, menthol ban
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 21 Jun 2021 (actual)
Primary completion: 29 Dec 2022 (actual)
Study completion: 29 Dec 2022 (actual)
First posted: 10 May 2021 (actual)
Results: Posted 26 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study team anticipates recruiting up to 100 participants to achieve 80 completers. Equal numbers of black and white participants will be enrolled.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
Model description: Participants will experience four marketplace conditions that differ in the availability of flavored e-liquids.

Arm	Type	Receives
Intervention 1: Fruit, dessert, mint, menthol, tobacco	Experimental	Behavioral: All e-liquid flavorsAll participants receive all interventional e-liquid flavors on separate days.
Intervention 2: Mint, menthol, and tobacco	Experimental	Behavioral: Mint, Menthol and Tobacco e-liquidsAll participants receive all interventional e-liquid flavors on separate days.
Intervention 3: Menthol and Tobacco	Experimental	Behavioral: Menthol and Tobacco e-liquidsAll participants receive all interventional e-liquid flavors on separate days.
Intervention 4: Only tobacco	Experimental	Behavioral: Tobacco e-liquidsAll participants receive all interventional e-liquid flavors on separate days.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

21+ years of age
Self-report smoking at least 5 cigarettes per day for the past year
Self-report smoking menthol cigarette brands > 80% of the time
Breathe carbon monoxide (CO) level > 8 ppm Willingness to use other tobacco products during the study
Speak, comprehend, and read English sufficiently to complete study procedures

Key exclusion criteria (7 listed)

Currently seeking treatment to quit smoking
Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
Body temperature > 100.4 F
Cold, flu or Novel Coronavirus (COVID-19) symptoms including fever, cough, and runny nose in the past 30 days
Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy

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 e-liquidsMarketplace includes tobacco flavored e-liquids	Behavioural	Intervention 4: Only tobacco
Menthol and Tobacco e-liquidsMarketplace includes menthol and tobacco flavored e-liquids	Behavioural	Intervention 3: Menthol and Tobacco
Mint, Menthol and Tobacco e-liquidsMarketplace includes mint, menthol and tobacco flavored e-liquids	Behavioural	Intervention 2: Mint, menthol, and tobacco
All e-liquid flavorsMarketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids	Behavioural	Intervention 1: Fruit, dessert, mint, menthol, tobacco

Primary outcome

Total Amount of Combusted Tobacco Purchased
Time frame: Day 3
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Total Amount of Combusted Tobacco Purchased
Time frame: Day 4
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Total Amount of Combusted Tobacco Purchased
Time frame: Day 5
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Total Amount of Combusted Tobacco Purchased
Time frame: Day 6
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.

1 secondary outcome

Total Amount of E-liquid Purchased
Time frame: Day 3, Day 4, Day 5, Day 6

Results and safety

Results posted to the registry on 26 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
E-liquid Availability	52	52

Primary outcome: Total Amount of Combusted Tobacco Purchased

Time frame: Day 3. Mean (Standard Deviation). Unit: mg

Measure	E-liquid Availability n = 50
Value	990.6 (1756.9)

Population analysed: 2 participants were excluded from data analysis due to receiving incorrect shopping links.

Primary outcome: Total Amount of Combusted Tobacco Purchased

Time frame: Day 4. Mean (Standard Deviation). Unit: mg

Measure	E-liquid Availability n = 49
Value	1185.9 (1510.4)

Population analysed: 2 participants were excluded from data analysis due to receiving incorrect shopping links. 1 participant was lost to follow up.

Primary outcome: Total Amount of Combusted Tobacco Purchased

Time frame: Day 5. Mean (Standard Deviation). Unit: mg

Measure	E-liquid Availability n = 49
Value	1154.1 (1839.6)

Population analysed: 2 participants were excluded from data analysis due to receiving incorrect shopping links. 1 participant was lost to follow up.

Primary outcome: Total Amount of Combusted Tobacco Purchased

Time frame: Day 6. Mean (Standard Deviation). Unit: mg

Measure	E-liquid Availability n = 50
Value	1318.2 (1678.6)

Population analysed: 2 participants were excluded from data analysis due to receiving incorrect shopping links.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline through Day 14. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
E-liquid Availability	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Limitations and caveats (from the sponsor): Several recruitment methods were utilized to identify participants including flyers, Craigslist and contracting with a clinical research recruitment agency. All methods yielded participants but ultimately were not enough to meet our enrollment goal of 80 participants. We experienced a significant uptick in the number of enrolled participants in the final months of the study. We attribute this to the temporal change that has resulted from a return to normal activities after the COVID-19 pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Rachel Denlinger, PhD, MPH principal investigator

Wake Forest Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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 26 Jun 2024. 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 26 Jun 2024). 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?

Total Amount of Combusted Tobacco Purchased (time frame: Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04879225.

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 26 Jun 2024.