Clinical trial NCT04879225: Menthol and Mint Experimental Tobacco Marketplace (ETM) Study
Official title: The Impact of Menthol and Mint E-liquid Bans on Menthol Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Vaping
Keywords: smoking
menthol
mint
vaping
menthol ban
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants will experience four marketplace conditions that differ in the availability of flavored e-liquids.
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total Amount of Combusted Tobacco Purchased
timeFrame: Day 3
measure: Total Amount of Combusted Tobacco Purchased
timeFrame: Day 4
measure: Total Amount of Combusted Tobacco Purchased
timeFrame: Day 5
measure: Total Amount of Combusted Tobacco Purchased
timeFrame: Day 6
Secondary outcomes:
measure: Total Amount of E-liquid Purchased
timeFrame: Day 3, Day 4, Day 5, Day 6
Other outcomes:
measure: Total Amount of Non-menthol Cigarettes
timeFrame: Day 3, Day 4, Day 5, Day 6
measure: Total Amount of Tobacco E-liquid Purchased
timeFrame: Day 3, Day 4, Day 5, Day 6
measure: Total Amount of Menthol E-liquid Purchased
timeFrame: Day 3, Day 4, Day 5, Day 6
measure: Total Amount of Mint E-liquid Purchased
timeFrame: Day 3, Day 4, Day 5, Day 6
measure: Total Amount of Dessert/Fruit E-liquid Purchased.
timeFrame: Day 3, Day 4, Day 5, Day 6
measure: Themes Emerging From the Qualitative Interviews
timeFrame: Day 14
measure: Mean Perceived Health Risk Scale Score
timeFrame: Baseline, Day 14
measure: Mean Product Evaluation Scale Score
timeFrame: Baseline, Day 14
measure: Mean Minnesota Nicotine Withdrawal Scale Score
timeFrame: Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
measure: Mean Questionnaire on Smoking Urges Score
timeFrame: Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
measure: Mean Tobacco Product Interest Scores
timeFrame: Baseline, Day 14
measure: Tobacco Policy Questionnaire Score
timeFrame: Baseline, Day 14
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Rachel Denlinger, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: