Cigarette Smoking, Vaping
Conditions
Keywords
smoking, menthol, mint, vaping, menthol ban
Brief summary
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.
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.
Interventions
BEHAVIORALTobacco e-liquids
Marketplace includes tobacco flavored e-liquids
BEHAVIORALMenthol and Tobacco e-liquids
Marketplace includes menthol and tobacco flavored e-liquids
BEHAVIORALMint, Menthol and Tobacco e-liquids
Marketplace includes mint, menthol and tobacco flavored e-liquids
BEHAVIORALAll e-liquid flavors
Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants will experience four marketplace conditions that differ in the availability of flavored e-liquids.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Combusted Tobacco Purchased | Day 3 | Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of E-liquid Purchased | Day 3, Day 4, Day 5, Day 6 | Total amount of e-liquid purchased when menthol cigarettes are not available. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Tobacco E-liquid Purchased | Day 3, Day 4, Day 5, Day 6 | Total amount of tobacco e-liquid purchased when menthol cigarettes are not available according to race. |
| Total Amount of Menthol E-liquid Purchased | Day 3, Day 4, Day 5, Day 6 | Total amount of menthol e-liquid purchased when menthol cigarettes are not available according to race. |
| Total Amount of Dessert/Fruit E-liquid Purchased. | 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. |
| Themes Emerging From the Qualitative Interviews | 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. |
| Mean Perceived Health Risk Scale Score | 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. |
| Total Amount of Mint E-liquid Purchased | Day 3, Day 4, Day 5, Day 6 | Total amount of mint e-liquid purchased when menthol cigarettes are not available according to race. |
| Mean Minnesota Nicotine Withdrawal Scale Score | 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. |
| Mean Questionnaire on Smoking Urges Score | 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. |
| Mean Tobacco Product Interest Scores | 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 |
| Tobacco Policy Questionnaire Score | 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. |
| Mean Product Evaluation Scale Score | 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. |
| Total Amount of Non-menthol Cigarettes | Day 3, Day 4, Day 5, Day 6 | Total amount purchased when menthol cigarettes are not available according to race |
Countries
United States
Participant flow
Pre-assignment details
14 participants screen failed prior to enrolling.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Menthol and Tobacco | Lost to Follow-up | 1 |
| Mint, Menthol, Tobacco | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | E-liquid Availability |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants |
| Age, Continuous | 44.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
Total Amount of Combusted Tobacco Purchased
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Time frame: Day 4
Population: 2 participants were excluded from data analysis due to receiving incorrect shopping links. 1 participant was lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-liquid Availability | Total Amount of Combusted Tobacco Purchased | 1185.9 mg | Standard Deviation 1510.4 |
Primary
Total Amount of Combusted Tobacco Purchased
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Time frame: Day 5
Population: 2 participants were excluded from data analysis due to receiving incorrect shopping links. 1 participant was lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-liquid Availability | Total Amount of Combusted Tobacco Purchased | 1154.1 mg | Standard Deviation 1839.6 |
Primary
Total Amount of Combusted Tobacco Purchased
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Time frame: Day 6
Population: 2 participants were excluded from data analysis due to receiving incorrect shopping links.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-liquid Availability | Total Amount of Combusted Tobacco Purchased | 1318.2 mg | Standard Deviation 1678.6 |
Primary
Total Amount of Combusted Tobacco Purchased
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Time frame: Day 3
Population: 2 participants were excluded from data analysis due to receiving incorrect shopping links.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-liquid Availability | Total Amount of Combusted Tobacco Purchased | 990.6 mg | Standard Deviation 1756.9 |
Secondary
Total Amount of E-liquid Purchased
Total amount of e-liquid purchased when menthol cigarettes are not available.
Time frame: Day 3, Day 4, Day 5, Day 6
Population: All active participants went through all four interventions on four different days.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-liquid Availability | Total Amount of E-liquid Purchased | Day 3 | 9.8 Mg | Standard Deviation 26.2 |
| Intervention 2: Mint, Menthol, and Tobacco | Total Amount of E-liquid Purchased | Day 4 | 13.1 Mg | Standard Deviation 36.4 |
| Intervention 3: Menthol and Tobacco | Total Amount of E-liquid Purchased | Day 5 | 22.4 Mg | Standard Deviation 47.8 |
| Intervention 4: Only Tobacco | Total Amount of E-liquid Purchased | Day 6 | 30.2 Mg | Standard Deviation 56.5 |
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.
Time frame: Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
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.
Time frame: Baseline, Day 14
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.
Time frame: Baseline, Day 14
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.
Time frame: Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
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: 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
Time frame: Baseline, Day 14
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.
Time frame: Day 14
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.
Time frame: Baseline, Day 14
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.
Time frame: Day 3, Day 4, Day 5, Day 6
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.
Time frame: Day 3, Day 4, Day 5, Day 6
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.
Time frame: 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
Time frame: Day 3, Day 4, Day 5, Day 6
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.
Time frame: Day 3, Day 4, Day 5, Day 6