Menthol and Mint Experimental Tobacco Marketplace (ETM) Study

NCT04879225 | Completed Results

• 1 other identifier: IRB00065077
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Vaping

Keywords

smoking; menthol; mint; vaping; menthol ban

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Total Amount of E-liquid Purchased

  Day 3, Day 4, Day 5, Day 6

Other Outcomes (12)

• Total Amount of Non-menthol Cigarettes

  Day 3, Day 4, Day 5, Day 6

• Total Amount of Tobacco E-liquid Purchased

  Day 3, Day 4, Day 5, Day 6

• Total Amount of Menthol E-liquid Purchased

  Day 3, Day 4, Day 5, Day 6

Study Arms (4)

Intervention 1: Fruit, dessert, mint, menthol, tobacco

EXPERIMENTAL

All participants receive all interventional e-liquid flavors on separate days.

Behavioral: All e-liquid flavors

Intervention 2: Mint, menthol, and tobacco

EXPERIMENTAL

All participants receive all interventional e-liquid flavors on separate days.

Behavioral: Mint, Menthol and Tobacco e-liquids

Intervention 3: Menthol and Tobacco

EXPERIMENTAL

All participants receive all interventional e-liquid flavors on separate days.

Behavioral: Menthol and Tobacco e-liquids

Intervention 4: Only tobacco

EXPERIMENTAL

All participants receive all interventional e-liquid flavors on separate days.

Behavioral: Tobacco e-liquids

Interventions

Tobacco e-liquids BEHAVIORAL

Marketplace includes tobacco flavored e-liquids

Intervention 4: Only tobacco

Menthol and Tobacco e-liquids BEHAVIORAL

Marketplace includes menthol and tobacco flavored e-liquids

Intervention 3: Menthol and Tobacco

Mint, Menthol and Tobacco e-liquids BEHAVIORAL

Marketplace includes mint, menthol and tobacco flavored e-liquids

Intervention 2: Mint, menthol, and tobacco

All e-liquid flavors BEHAVIORAL

Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids

Intervention 1: Fruit, dessert, mint, menthol, tobacco

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Vaping; Smoking

Interventions

Menthol; SPEN protein, human

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Limitations and Caveats

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.

Results Point of Contact

• Title: Emily Harwood
• Organization: Wake Forest University School of Medicine

eaharwoo@wakehealth.edu

8284067599

Study Officials

• Rachel Denlinger, PhD, MPH

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will experience four marketplace conditions that differ in the availability of flavored e-liquids.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 10, 2021
• Study Start: June 21, 2021
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)