Trial Outcomes & Findings for Menthol and Mint Experimental Tobacco Marketplace (ETM) Study (NCT NCT04879225)
NCT ID: NCT04879225
Last Updated: 2024-06-26
Results Overview
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
COMPLETED
NA
66 participants
Day 3
2024-06-26
Participant Flow
14 participants screen failed prior to enrolling.
Participant milestones
| Measure |
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
|
|---|---|
|
Fruit, Dessert, Mint, Menthol, Tobacco
STARTED
|
52
|
|
Fruit, Dessert, Mint, Menthol, Tobacco
COMPLETED
|
52
|
|
Fruit, Dessert, Mint, Menthol, Tobacco
NOT COMPLETED
|
0
|
|
Mint, Menthol, Tobacco
STARTED
|
52
|
|
Mint, Menthol, Tobacco
COMPLETED
|
51
|
|
Mint, Menthol, Tobacco
NOT COMPLETED
|
1
|
|
Menthol and Tobacco
STARTED
|
52
|
|
Menthol and Tobacco
COMPLETED
|
51
|
|
Menthol and Tobacco
NOT COMPLETED
|
1
|
|
Only Tobacco
STARTED
|
52
|
|
Only Tobacco
COMPLETED
|
52
|
|
Only Tobacco
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Mint, Menthol, Tobacco
Lost to Follow-up
|
1
|
|
Menthol and Tobacco
Lost to Follow-up
|
1
|
Baseline Characteristics
Menthol and Mint Experimental Tobacco Marketplace (ETM) Study
Baseline characteristics by cohort
| Measure |
E-liquid Availability
n=52 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
44.9 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 3Population: 2 participants were excluded from data analysis due to receiving incorrect shopping links.
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Outcome measures
| Measure |
E-liquid Availability
n=50 Participants
All e-liquid flavors: Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
|
Intervention 2: Mint, Menthol, and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Mint, Menthol and Tobacco e-liquids: Marketplace includes mint, menthol and tobacco flavored e-liquids
|
Intervention 3: Menthol and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Menthol and Tobacco e-liquids: Marketplace includes menthol and tobacco flavored e-liquids
|
Intervention 4: Only Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Tobacco e-liquids: Marketplace includes tobacco flavored e-liquids
|
|---|---|---|---|---|
|
Total Amount of Combusted Tobacco Purchased
|
990.6 mg
Standard Deviation 1756.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 4Population: 2 participants were excluded from data analysis due to receiving incorrect shopping links. 1 participant was lost to follow up.
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Outcome measures
| Measure |
E-liquid Availability
n=49 Participants
All e-liquid flavors: Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
|
Intervention 2: Mint, Menthol, and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Mint, Menthol and Tobacco e-liquids: Marketplace includes mint, menthol and tobacco flavored e-liquids
|
Intervention 3: Menthol and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Menthol and Tobacco e-liquids: Marketplace includes menthol and tobacco flavored e-liquids
|
Intervention 4: Only Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Tobacco e-liquids: Marketplace includes tobacco flavored e-liquids
|
|---|---|---|---|---|
|
Total Amount of Combusted Tobacco Purchased
|
1185.9 mg
Standard Deviation 1510.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: 2 participants were excluded from data analysis due to receiving incorrect shopping links. 1 participant was lost to follow up.
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Outcome measures
| Measure |
E-liquid Availability
n=49 Participants
All e-liquid flavors: Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
|
Intervention 2: Mint, Menthol, and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Mint, Menthol and Tobacco e-liquids: Marketplace includes mint, menthol and tobacco flavored e-liquids
|
Intervention 3: Menthol and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Menthol and Tobacco e-liquids: Marketplace includes menthol and tobacco flavored e-liquids
|
Intervention 4: Only Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Tobacco e-liquids: Marketplace includes tobacco flavored e-liquids
|
|---|---|---|---|---|
|
Total Amount of Combusted Tobacco Purchased
|
1154.1 mg
Standard Deviation 1839.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 6Population: 2 participants were excluded from data analysis due to receiving incorrect shopping links.
Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.
Outcome measures
| Measure |
E-liquid Availability
n=50 Participants
All e-liquid flavors: Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
|
Intervention 2: Mint, Menthol, and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Mint, Menthol and Tobacco e-liquids: Marketplace includes mint, menthol and tobacco flavored e-liquids
|
Intervention 3: Menthol and Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Menthol and Tobacco e-liquids: Marketplace includes menthol and tobacco flavored e-liquids
|
Intervention 4: Only Tobacco
All participants receive all interventional e-liquid flavors on separate days.
Tobacco e-liquids: Marketplace includes tobacco flavored e-liquids
|
|---|---|---|---|---|
|
Total Amount of Combusted Tobacco Purchased
|
1318.2 mg
Standard Deviation 1678.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3, Day 4, Day 5, Day 6Population: All active participants went through all four interventions on four different days.
Total amount of e-liquid purchased when menthol cigarettes are not available.
Outcome measures
| Measure |
E-liquid Availability
n=50 Participants
All e-liquid flavors: Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
|
Intervention 2: Mint, Menthol, and Tobacco
n=49 Participants
All participants receive all interventional e-liquid flavors on separate days.
Mint, Menthol and Tobacco e-liquids: Marketplace includes mint, menthol and tobacco flavored e-liquids
|
Intervention 3: Menthol and Tobacco
n=49 Participants
All participants receive all interventional e-liquid flavors on separate days.
Menthol and Tobacco e-liquids: Marketplace includes menthol and tobacco flavored e-liquids
|
Intervention 4: Only Tobacco
n=50 Participants
All participants receive all interventional e-liquid flavors on separate days.
Tobacco e-liquids: Marketplace includes tobacco flavored e-liquids
|
|---|---|---|---|---|
|
Total Amount of E-liquid Purchased
Day 3
|
9.8 Mg
Standard Deviation 26.2
|
—
|
—
|
—
|
|
Total Amount of E-liquid Purchased
Day 4
|
—
|
13.1 Mg
Standard Deviation 36.4
|
—
|
—
|
|
Total Amount of E-liquid Purchased
Day 5
|
—
|
—
|
22.4 Mg
Standard Deviation 47.8
|
—
|
|
Total Amount of E-liquid Purchased
Day 6
|
—
|
—
|
—
|
30.2 Mg
Standard Deviation 56.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3, Day 4, Day 5, Day 6Total amount purchased when menthol cigarettes are not available according to race
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3, Day 4, Day 5, Day 6Total amount of tobacco e-liquid purchased when menthol cigarettes are not available according to race.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3, Day 4, Day 5, Day 6Total amount of menthol e-liquid purchased when menthol cigarettes are not available according to race.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3, Day 4, Day 5, Day 6Total amount of mint e-liquid purchased when menthol cigarettes are not available according to race.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3, Day 4, Day 5, Day 6Total amount of dessert/fruit e-liquid purchased when menthol cigarettes are not available according to race.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14Qualitative 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14This 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14This 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 3, Day 4, Day 5, Day 6, Day 14This 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 3, Day 4, Day 5, Day 6, Day 14This 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14A 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14A 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.
Outcome measures
Outcome data not reported
Adverse Events
E-liquid Availability
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place