- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04879225
Menthol and Mint Experimental Tobacco Marketplace (ETM) Study
The Impact of Menthol and Mint E-liquid Bans on Menthol Cigarette Smokers
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emily Harwood, MPH
- Phone Number: 336-716-6823
- Email: eaharwoo@wakehealth.edu
Study Contact Backup
- Name: Darcy Lockhart, BA
- Email: alaverdi@wakehealth.edu
Study Locations
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 21+ 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: E-liquid Availability
Flavor availability is manipulated
|
Marketplace includes tobacco flavored e-liquids
Marketplace includes menthol and tobacco flavored e-liquids
Marketplace includes mint, menthol and tobacco flavored e-liquids
Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total amount of combusted tobacco purchased
Time Frame: Day 3
|
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
|
Day 3
|
Total amount of combusted tobacco purchased
Time Frame: Day 4
|
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
|
Day 4
|
Total amount of combusted tobacco purchased
Time Frame: Day 5
|
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
|
Day 5
|
Total amount of combusted tobacco purchased
Time Frame: Day 6
|
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
|
Day 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total amount of tobacco e-liquid purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
|
Total amount of tobacco e-liquid purchased when menthol cigarettes are not available.
|
Day 3, Day 4, Day 5, Day 6
|
Total amount of menthol e-liquid purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
|
Total amount of menthol e-liquid purchased when menthol cigarettes are not available.
|
Day 3, Day 4, Day 5, Day 6
|
Total amount of mint e-liquid purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
|
Total amount of mint e-liquid purchased when menthol cigarettes are not available
|
Day 3, Day 4, Day 5, Day 6
|
Total amount of dessert and fruit e-liquid purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
|
Total amount of dessert and fruit e-liquid purchased with menthol cigarettes are not available
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Day 3, Day 4, Day 5, Day 6
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total amount of non-menthol cigarettes
Time Frame: Day 3, Day 4, Day 5, Day 6
|
Total amount purchased when menthol cigarettes are not available according to race
|
Day 3, Day 4, Day 5, Day 6
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Total Amount of Tobacco e-liquid Purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
|
Total amount of tobacco e-liquid purchased when menthol cigarettes are not available according to race.
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Day 3, Day 4, Day 5, Day 6
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Total Amount of Menthol e-liquid Purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
|
Total amount of menthol e-liquid purchased when menthol cigarettes are not available according to race.
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Day 3, Day 4, Day 5, Day 6
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Total Amount of Mint e-liquid Purchased
Time Frame: Day 3, Day 4, Day 5, Day 6
|
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.
Time Frame: 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.
|
Day 3, Day 4, Day 5, Day 6
|
Themes emerging from the qualitative interviews
Time Frame: 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.
|
Day 14
|
Mean Perceived Health Risk Scale Score
Time Frame: 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.
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Baseline, Day 14
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Mean Product Evaluation Scale Score
Time Frame: 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.
|
Baseline, Day 14
|
Mean Minnesota Nicotine Withdrawal Scale Score
Time Frame: 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.
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Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
|
Mean Questionnaire on Smoking Urges Score
Time Frame: 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.
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Baseline, Day 3, Day 4, Day 5, Day 6, Day 14
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Mean Tobacco Product Interest Scores
Time Frame: 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:
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Baseline, Day 14
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Tobacco Policy Questionnaire Score
Time Frame: 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.
|
Baseline, Day 14
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rachel Denlinger, PhD, MPH, Wake Forest Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00065077
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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