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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Day 3

Results posted on

2024-06-26

Participant Flow

14 participants screen failed prior to enrolling.

Participant milestones

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

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

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 3

Population: 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

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 4

Population: 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

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 5

Population: 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

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 6

Population: 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

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 6

Population: 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

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 6

Total 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 6

Total 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 6

Total 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 6

Total 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 6

Total 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 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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: 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 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.

Outcome measures

Outcome data not reported

Adverse Events

E-liquid Availability

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emily Harwood

Wake Forest University School of Medicine

Phone: 8284067599

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place