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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1: Fruit, dessert, mint, menthol, tobacco | Experimental | All participants receive all interventional e-liquid flavors on separate days. |
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| Intervention 2: Mint, menthol, and tobacco | Experimental | All participants receive all interventional e-liquid flavors on separate days. |
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| Intervention 3: Menthol and Tobacco | Experimental | All participants receive all interventional e-liquid flavors on separate days. |
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| Intervention 4: Only tobacco | Experimental | All participants receive all interventional e-liquid flavors on separate days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco e-liquids | Behavioral | Marketplace includes tobacco flavored e-liquids |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Combusted Tobacco Purchased | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. | Day 3 |
| Total Amount of Combusted Tobacco Purchased | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. | Day 4 |
| Total Amount of Combusted Tobacco Purchased | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. | Day 5 |
| Total Amount of Combusted Tobacco Purchased | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of E-liquid Purchased | Total amount of e-liquid purchased when menthol cigarettes are not available. | Day 3, Day 4, Day 5, Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Non-menthol Cigarettes | 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 | Total amount of tobacco e-liquid purchased when menthol cigarettes are not available according to race. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Denlinger, PhD, MPH | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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14 participants screen failed prior to enrolling.
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| ID | Title | Description |
|---|---|---|
| FG000 | E-liquid Availability | Flavor availability is manipulated Tobacco e-liquids: Marketplace includes tobacco flavored e-liquids Menthol and Tobacco e-liquids: Marketplace includes menthol and tobacco flavored e-liquids Mint, Menthol and Tobacco e-liquids: Marketplace includes mint, menthol and tobacco flavored e-liquids All e-liquid flavors: Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fruit, Dessert, Mint, Menthol, Tobacco |
| |||||||||||||
| Mint, Menthol, Tobacco |
| |||||||||||||
| Menthol and Tobacco |
| |||||||||||||
| Only Tobacco |
|
Two participants were excluded from data analysis due to being unable to verify what shopping conditions the participants received.
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| ID | Title | Description |
|---|---|---|
| BG000 | E-liquid Availability | Flavor availability is manipulated Tobacco e-liquids: Marketplace includes tobacco flavored e-liquids Menthol and Tobacco e-liquids: Marketplace includes menthol and tobacco flavored e-liquids Mint, Menthol and Tobacco e-liquids: Marketplace includes mint, menthol and tobacco flavored e-liquids All e-liquid flavors: Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Amount of Combusted Tobacco Purchased | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. | 2 participants were excluded from data analysis due to receiving incorrect shopping links. | Posted | Mean | Standard Deviation | mg | Day 3 |
|
|
Baseline through Day 14
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E-liquid Availability | Flavor availability is manipulated Tobacco e-liquids: Marketplace includes tobacco flavored e-liquids Menthol and Tobacco e-liquids: Marketplace includes menthol and tobacco flavored e-liquids Mint, Menthol and Tobacco e-liquids: Marketplace includes mint, menthol and tobacco flavored e-liquids All e-liquid flavors: Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Harwood | Wake Forest University School of Medicine | 8284067599 | eaharwoo@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2022 | Jun 21, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 11, 2022 | Jun 21, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D000072137 | Vaping |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D008610 | Menthol |
| C476510 | SPEN protein, human |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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Participants will experience four marketplace conditions that differ in the availability of flavored e-liquids.
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| Menthol and Tobacco e-liquids | Behavioral | Marketplace includes menthol and tobacco flavored e-liquids |
|
| Mint, Menthol and Tobacco e-liquids | Behavioral | Marketplace includes mint, menthol and tobacco flavored e-liquids |
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| All e-liquid flavors | Behavioral | Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids |
|
| Day 3, Day 4, Day 5, Day 6 |
| Total Amount of Menthol E-liquid Purchased | 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 | 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. | 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 | 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 |
| Mean Perceived Health Risk Scale Score | 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 | 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 | 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 | 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 | 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:
| Baseline, Day 14 |
| Tobacco Policy Questionnaire Score | 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 |
|
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Total Amount of Combusted Tobacco Purchased | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. | 2 participants were excluded from data analysis due to receiving incorrect shopping links. 1 participant was lost to follow up. | Posted | Mean | Standard Deviation | mg | Day 4 |
|
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| Primary | Total Amount of Combusted Tobacco Purchased | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. | 2 participants were excluded from data analysis due to receiving incorrect shopping links. 1 participant was lost to follow up. | Posted | Mean | Standard Deviation | mg | Day 5 |
|
|
|
| Primary | Total Amount of Combusted Tobacco Purchased | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. | 2 participants were excluded from data analysis due to receiving incorrect shopping links. | Posted | Mean | Standard Deviation | mg | Day 6 |
|
|
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| Secondary | Total Amount of E-liquid Purchased | Total amount of e-liquid purchased when menthol cigarettes are not available. | All active participants went through all four interventions on four different days. | Posted | Mean | Standard Deviation | Mg | Day 3, Day 4, Day 5, Day 6 |
|
|
|
| Other Pre-specified | Total Amount of Non-menthol Cigarettes | Total amount purchased when menthol cigarettes are not available according to race | Not Posted | Day 3, Day 4, Day 5, Day 6 | Participants |
| Other Pre-specified | Total Amount of Tobacco E-liquid Purchased | Total amount of tobacco e-liquid purchased when menthol cigarettes are not available according to race. | Not Posted | Day 3, Day 4, Day 5, Day 6 | Participants |
| Other Pre-specified | Total Amount of Menthol E-liquid Purchased | Total amount of menthol e-liquid purchased when menthol cigarettes are not available according to race. | Not Posted | Day 3, Day 4, Day 5, Day 6 | Participants |
| Other Pre-specified | Total Amount of Mint E-liquid Purchased | Total amount of mint e-liquid purchased when menthol cigarettes are not available according to race. | Not Posted | Day 3, Day 4, Day 5, Day 6 | Participants |
| Other Pre-specified | Total Amount of Dessert/Fruit E-liquid Purchased. | Total amount of dessert/fruit e-liquid purchased when menthol cigarettes are not available according to race. | Not Posted | Day 3, Day 4, Day 5, Day 6 | Participants |
| Other Pre-specified | Themes Emerging From the Qualitative Interviews | 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. | Not Posted | Day 14 | Participants |
| Other Pre-specified | Mean Perceived Health Risk Scale Score | 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. | Not Posted | Baseline, Day 14 | Participants |
| Other Pre-specified | Mean Product Evaluation Scale Score | 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. | Not Posted | Baseline, Day 14 | Participants |
| Other Pre-specified | Mean Minnesota Nicotine Withdrawal Scale Score | 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. | Not Posted | Baseline, Day 3, Day 4, Day 5, Day 6, Day 14 | Participants |
| Other Pre-specified | Mean Questionnaire on Smoking Urges Score | 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. | Not Posted | Baseline, Day 3, Day 4, Day 5, Day 6, Day 14 | Participants |
| Other Pre-specified | Mean Tobacco Product Interest Scores | 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:
| Not Posted | Baseline, Day 14 | Participants |
| Other Pre-specified | Tobacco Policy Questionnaire Score | 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. | Not Posted | Baseline, Day 14 | Participants |
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
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| Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |
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| Day 5 |
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| Day 6 |
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