Menthol and Mint Experimental Tobacco Marketplace (ETM) Study

June 21, 2024 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 21+ years of age
  2. Self-report smoking at least 5 cigarettes per day for the past year
  3. Self-report smoking menthol cigarette brands > 80% of the time
  4. Breathe carbon monoxide (CO) level > 8 ppm Willingness to use other tobacco products during the study
  5. Speak, comprehend, and read English sufficiently to complete study procedures
  6. Have home access to a computer or tablet with a web camera and internet access

Exclusion Criteria:

  1. Currently seeking treatment to quit smoking
  2. Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
  3. Body temperature > 100.4 F
  4. Cold, flu or Novel Coronavirus (COVID-19) symptoms including fever, cough, and runny nose in the past 30 days
  5. 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
  6. CO reading > 80 ppm
  7. Enrollment stratum (Non-Hispanic, white or Black/African American)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention 1: Fruit, dessert, mint, menthol, tobacco
All participants receive all interventional e-liquid flavors on separate days.
Behavioral: All e-liquid flavors
Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
Experimental: Intervention 2: Mint, menthol, and tobacco
All participants receive all interventional e-liquid flavors on separate days.
Behavioral: Mint, Menthol and Tobacco e-liquids
Marketplace includes mint, menthol and tobacco flavored e-liquids
Experimental: Intervention 3: Menthol and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Behavioral: Menthol and Tobacco e-liquids
Marketplace includes menthol and tobacco flavored e-liquids
Experimental: Intervention 4: Only tobacco
All participants receive all interventional e-liquid flavors on separate days.
Behavioral: Tobacco e-liquids
Marketplace includes tobacco flavored e-liquids

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Amount of Combusted Tobacco Purchased
Time Frame: Day 3
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Day 3
Total Amount of Combusted Tobacco Purchased
Time Frame: Day 4
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Day 4
Total Amount of Combusted Tobacco Purchased
Time Frame: Day 5
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Day 5
Total Amount of Combusted Tobacco Purchased
Time Frame: Day 6
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Day 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Amount of E-liquid Purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
Total amount of e-liquid purchased when menthol cigarettes are not available.
Day 3, Day 4, Day 5, Day 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Perceived Health Risk Scale Score
Time Frame: Baseline, Day 14
This is a measure of the perceived addictive potential and other health risks associated with cigarettes, e-cigarettes and nicotine gum. Scale 1-10 (1=very low risk of disease and 10=very high risk of disease). Each item/question has a score of 1-10. There are 14 different items in this questionnaire and each item will be evaluated independently.
Baseline, Day 14
Mean Product Evaluation Scale Score
Time Frame: Baseline, Day 14
This scale measures the participant's experience while using cigarettes, nicotine gum, or vaping devices. Each of the three products will include 13 items with a total score range of 13-91 for each of the three products. A higher score denotes more enjoyment from the product.
Baseline, Day 14
Mean Minnesota Nicotine Withdrawal Scale Score
Time Frame: Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
This is a 15-item self-reported scale to evaluate the effects of smoking cessation and withdrawal symptoms. This scale is important because it allows the researchers to understand the experience of the participant throughout the study while using various tobacco products. The study team will use 7/15 items from this scale each ranging in score from 1-5. Total score range for the questionnaire would be 7-35 with higher score denoting more severe symptoms.
Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
Mean Questionnaire on Smoking Urges Score
Time Frame: Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
This scale measures the person's urge to smoke throughout the study while potentially using various tobacco and nicotine products. This questionnaire consists of 10 items each ranging from 1-7. Total score range for the entire questionnaire is 10-70. A higher score denotes greater urge.
Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
Mean Tobacco Product Interest Scores
Time Frame: Baseline, Day 14

A visual analog scale assessing interest in use of various tobacco and nicotine products. Each item has a score from 0-100. This scale ranges from no interest (0) to very interested (100). The total questionnaire has 9 items that will be evaluated independently. The study team is looking at the following:

  1. Preferred cigarette brand
  2. Any other cigarette brand
  3. A cigarette brand with 95% less nicotine
  4. I Quit Ordinary Smoking (IQOS) Heat-Not-Burn Device
  5. Juice Universal Serial Bus Lighting (JUUL) Vaping Device
  6. Zyn Nicotine Pouches
  7. NicoDerm Nicotine Patch
  8. Nicorette Nicotine Lozenge
  9. Nicorette Nicotine Gum
Baseline, Day 14
Tobacco Policy Questionnaire Score
Time Frame: Baseline, Day 14
A visual analog scale assessing interest in use of various tobacco and nicotine products. This questionnaire will assess support for various tobacco control policies, including banning menthol flavoring in cigarettes and e-cigarettes. Each of the 14 items has a score of 1-3. 1 means the subject is supportive of the policy, 2 means subject is opposed. 3 indicates that the subject does not know. Each of the 14 items will be evaluated independently from one another.
Baseline, Day 14
Total Amount of Non-menthol Cigarettes
Time Frame: Day 3, Day 4, Day 5, Day 6
Total amount purchased when menthol cigarettes are not available according to race
Day 3, Day 4, Day 5, Day 6
Total Amount of Tobacco E-liquid Purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
Total amount of tobacco e-liquid purchased when menthol cigarettes are not available according to race.
Day 3, Day 4, Day 5, Day 6
Total Amount of Menthol E-liquid Purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
Total amount of menthol e-liquid purchased when menthol cigarettes are not available according to race.
Day 3, Day 4, Day 5, Day 6
Total Amount of Mint E-liquid Purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
Total amount of mint e-liquid purchased when menthol cigarettes are not available according to race.
Day 3, Day 4, Day 5, Day 6
Total Amount of Dessert/Fruit E-liquid Purchased.
Time Frame: Day 3, Day 4, Day 5, Day 6
Total amount of dessert/fruit e-liquid purchased when menthol cigarettes are not available according to race.
Day 3, Day 4, Day 5, Day 6
Themes Emerging From the Qualitative Interviews
Time Frame: Day 14
Qualitative interviews will be conducted and then analyzed in an effort to learn common themes or trends among the participants specific to various tobacco and nicotine products.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Denlinger, PhD, MPH, Wake Forest Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00065077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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