Menthol and Mint Experimental Tobacco Marketplace (ETM) Study

Cigarette Smoking Clinical Trial

Official title:

The Impact of Menthol and Mint E-liquid Bans on Menthol Cigarette Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879225
• Other study ID #: IRB00065077
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: December 29, 2022

Study information

• Verified date: April 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 29, 2022
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cigarette Smoking
• Vaping

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Total Amount of Tobacco e-liquid Purchased	Total amount of tobacco e-liquid purchased when menthol cigarettes are not available according to race.	Day 3, Day 4, Day 5, Day 6
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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: Preferred cigarette brand; Any other cigarette brand; A cigarette brand with 95% less nicotine; I Quit Ordinary Smoking (IQOS) Heat-Not-Burn Device; Juice Universal Serial Bus Lighting (JUUL) Vaping Device; Zyn Nicotine Pouches; NicoDerm Nicotine Patch; Nicorette Nicotine Lozenge; Nicorette Nicotine Gum	Baseline, Day 14
Other	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
Primary	Total amount of combusted tobacco purchased	Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.	Day 3
Primary	Total amount of combusted tobacco purchased	Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.	Day 4
Primary	Total amount of combusted tobacco purchased	Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.	Day 5
Primary	Total amount of combusted tobacco purchased	Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.	Day 6
Secondary	Total amount of tobacco e-liquid purchased	Total amount of tobacco e-liquid purchased when menthol cigarettes are not available.	Day 3, Day 4, Day 5, Day 6
Secondary	Total amount of menthol e-liquid purchased	Total amount of menthol e-liquid purchased when menthol cigarettes are not available.	Day 3, Day 4, Day 5, Day 6
Secondary	Total amount of mint e-liquid purchased	Total amount of mint e-liquid purchased when menthol cigarettes are not available	Day 3, Day 4, Day 5, Day 6
Secondary	Total amount of dessert and fruit e-liquid purchased	Total amount of dessert and fruit e-liquid purchased with menthol cigarettes are not available	Day 3, Day 4, Day 5, Day 6