Trial Outcomes & Findings for Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM) (NCT NCT05320887)
NCT ID: NCT05320887
Last Updated: 2024-10-09
Results Overview
Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)
COMPLETED
NA
69 participants
Visit 6 approximately 4 weeks after baseline
2024-10-09
Participant Flow
Out of the initial 69 participants enrolled, 5 people were lost to follow up or withdrew between screening eligible and getting randomized to a group leaving 64 participants randomized. Staff instructed participants that one iteration of the task would be randomly selected and would determine which products (flavor e-liquids or tobacco e-liquids) they would use during the assessment. In reality, participants were only randomly assigned to tobacco e-liquid and never assigned to flavor e-liquid.
Participant milestones
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
32
|
0
|
32
|
|
Overall Study
COMPLETED
|
0
|
29
|
0
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
0
|
Baseline Characteristics
Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM)
Baseline characteristics by cohort
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
32 Participants
n=107 Participants
|
—
|
29 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=107 Participants
|
—
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Age, Continuous
|
—
|
49.2 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
—
|
50.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 11.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
—
|
18 Participants
n=107 Participants
|
—
|
18 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
—
|
14 Participants
n=107 Participants
|
—
|
14 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
—
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
32 Participants
n=107 Participants
|
—
|
28 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
1 Participants
n=107 Participants
|
—
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
16 Participants
n=107 Participants
|
—
|
15 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
—
|
15 Participants
n=107 Participants
|
—
|
16 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
—
|
32 participants
n=107 Participants
|
—
|
32 participants
n=7 Participants
|
64 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Visit 6 approximately 4 weeks after baselinePopulation: Among those participants who purchased cigarettes in Shopping Trip 7 at Virtual Visit 6, the average number of cigarettes purchased (in an experimental tobacco marketplace where packs of very low nicotine content (VLNC) cigarettes, bottles of e-liquid matched to their randomization condition, boxes of nicotine gum were available).
Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Number of Cigarettes Purchased
|
—
|
154.7 average number of cigarettes
Standard Deviation 131.7
|
—
|
119.2 average number of cigarettes
Standard Deviation 55.5
|
SECONDARY outcome
Timeframe: Visit 6 approximately 4 weeks after baselinePopulation: Among those participants who purchased e-liquid in Shopping Trip 7 at Virtual Visit 6, the average number of mls purchased (in an experimental tobacco marketplace where packs of VLNC cigarettes, bottles of e-liquid matched to their randomization condition, boxes of nicotine gum were available).
Average number of e-liquid milliliters purchased (analyzed as raw data and using derived behavioral economic measures)
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Number of E-liquid Milliliters Purchased
|
—
|
36.7 average number of milliliters
Standard Deviation 24.1
|
—
|
35.0 average number of milliliters
Standard Deviation 29.6
|
SECONDARY outcome
Timeframe: Month 1 after baselinePopulation: Scores reveal how important each product characteristic is to a participant when indicating their preference for one product over another (0 to 100, summing to 100). In our study, product type (2 levels: cigarette or e-cigarette), cigarette nicotine content (2 levels: normal or very low), e-liquid nicotine content (2 levels: 25mg/ml or 50mg/g) and available e-liquid flavor (2 levels: mint, fruit, sweet, tobacco or only tobacco) were manipulated in the discrete choice experiment.
The proportion of participants projected to choose a cigarette over an e-cigarette under different potential regulatory scenarios, as determined by regression analysis.
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections
|
—
|
41.8 Proportion of participants
|
—
|
61.9 Proportion of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Group average for responses using a 10-point Likert-like scale: 1 = very low risk of disease; 2, 3, 4, 5, 6, 7, 8, 9, 10 = very high risk of disease. Minimum possible response 1. Maximum possible response 10. The higher the score, the greater perceived risk of VLNC cigarettes for lung cancer.
The response options rely on a 10-point Likert-like scale: 1 = very low risk of disease; 2, 3, 4, 5, 6, 7, 8, 9, 10 = very high risk of disease. Minimum possible response 1. Maximum possible response 10. The higher the score, the greater perceived risk of VLNC cigarettes for lung cancer.
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Lung Cancer Perceived Risk Scores for VLNC Cigarettes
|
—
|
5.4 score on a scale
Standard Deviation 2.9
|
—
|
4.2 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Visit 6 approximately 4 weeks after baselinePopulation: Group Averages, summed score of 13 items The product evaluation questionnaire measures the strength of self-reported positive effects (e.g., reward, satisfaction) following product use. The response options rely on a 7-point Likert-like scale: 1=not at all; 2= very little; 3= a little; 4= moderately; 5= a lot; 6= quite a lot; 7= extremely. Only administered to participants who received each product type in the field.
Product evaluation scale scores for VLNC cigarettes among participants who received VLNC cigarettes will be determined by a product evaluation questionnaire. The questionnaire measures the strength of self-reported positive subjective effects (e.g., reward, satisfaction) following product use. The response options rely on a 7-point Likert-like scale: 1=not at all; 2= very little; 3= a little; 4= moderately; 5= a lot; 6= quite a lot; 7= extremely. The summed score adds responses to 13 separate items. Minimum possible response: 13. Maximum possible response: 91. Higher scores denote more favorable product effects. Note: This was only administered (at Virtual Visit 6) to participants who received each product type in the field (dependent on their baseline ETM shopping trip purchases).
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=19 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=30 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Product Evaluation Scale Scores
|
—
|
29.1 score on a scale
Standard Deviation 15.3
|
—
|
29.1 score on a scale
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: Visit 6 approximately 4 weeks after baselinePopulation: Group averages, summed score of 7 items Minnesota Nicotine Withdrawal Scale measures the severity of nicotine withdrawal symptoms. The response options rely on a 5-point Likert-like scale; 0=None; 1= Slight; 2=Mild; 3=Moderate; 4=Severe. Minimum possible response: 0. Maximum possible response: 28. Higher scores denote greater severity of withdrawal symptoms.
Minnesota Nicotine Withdrawal Scale measures the severity of nicotine withdrawal symptoms. The response options rely on a 5-point Likert-like scale; 0=None; 1= Slight; 2=Mild; 3=Moderate; 4=Severe. There are 7 items total, that are summed. Minimum possible response: 0. Maximum possible response: 28. Higher scores denote greater severity of withdrawal symptoms.
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Minnesota Nicotine Withdrawal Scale Scores
|
—
|
5.3 score on a scale
Standard Deviation 5.9
|
—
|
4.9 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Visit 6 approximately 4 weeks after baselinePopulation: Group averages, summed score of 10 items Questionnaire on Smoking Urges measures the strength of urges to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree. The questionnaire has 10 total items; scores sum responses to each item. Minimum possible response: 10. Maximum possible response: 70. Higher scores denote greater urges to smoke.
Questionnaire on Smoking Urges measures the strength of urges to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree. The questionnaire has 10 total items; scores sum responses to each item. Minimum possible response: 10. Maximum possible response: 70. Higher scores denote greater urges to smoke.
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Questionnaire on Smoking Urges Score
|
—
|
36.1 score on a scale
Standard Deviation 18.7
|
—
|
32.4 score on a scale
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: 1 month after baselinePopulation: Product interest toward different cigarettes and e-cigarettes; Slider scale ranging from 0 = No Interest to 100 = Very Interested Ppts were not actually randomized to "all flavor e-liquids"
Tobacco Product Interest of different products; Slider scale ranging from 0=No Interest to 100=Very Interested
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Tobacco Product Interest Scores
UB Cigs
|
—
|
87.2 score on a scale
Interval 0.0 to 100.0
|
—
|
88.4 score on a scale
Interval 0.0 to 100.0
|
|
Tobacco Product Interest Scores
VLNC
|
—
|
27.1 score on a scale
Interval 0.0 to 100.0
|
—
|
32.2 score on a scale
Interval 0.0 to 100.0
|
|
Tobacco Product Interest Scores
Pod E-Cig
|
—
|
38.3 score on a scale
Interval 0.0 to 100.0
|
—
|
33.2 score on a scale
Interval 0.0 to 100.0
|
|
Tobacco Product Interest Scores
Mod E-Cig
|
—
|
15.4 score on a scale
Interval 0.0 to 100.0
|
—
|
35.6 score on a scale
Interval 0.0 to 100.0
|
|
Tobacco Product Interest Scores
Pen E-Cig
|
—
|
31.0 score on a scale
Interval 0.0 to 100.0
|
—
|
40.3 score on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 month after baselinePopulation: Ppts were not actually randomized to "all flavor" e-liquid groups.
Tobacco Policy Questionnaire scored from Support, Oppose, and Don't know for personal opinions on Making Cigarettes Less Addictive
Outcome measures
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 Participants
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 Participants
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Tobacco Policy Questionnaire Scores
Don't Know
|
—
|
7 Participants
|
—
|
10 Participants
|
|
Tobacco Policy Questionnaire Scores
Support
|
—
|
15 Participants
|
—
|
11 Participants
|
|
Tobacco Policy Questionnaire Scores
Oppose
|
—
|
7 Participants
|
—
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening visit through end of study (up to week eight)Participants are asked about their opinions and experiences using tobacco products other than their usual brand during the field assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening visit through end of study (up to week eight)Participants are asked what products they had used and quantity every day during the field assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening visit through end of study (up to week eight)Product use and biomarkers of exposure during the field assessment will be analyzed using linear regression or other appropriate regression models. The model for primary analysis of these data will include main effects for each of the two factors (for the ETM condition carried into the field assessment), and the corresponding baseline measure to improve precision. Carbon Monoxide (CO) is collected in ppm.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening visit through end of study (up to week eight)Product use and biomarkers of exposure during the field assessment will be analyzed using linear regression or other appropriate regression models. The model for primary analysis of these data will include main effects for each of the two factors (for the ETM condition carried into the field assessment), and the corresponding baseline measure to improve precision. Cotinine is collected in ng/ml.
Outcome measures
Outcome data not reported
Adverse Events
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape With Tobacco E-liquids
Low Nicotine Content Vape With All Flavor E-liquids
Low Nicotine Content Vape With Tobacco E-liquids
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Nicotine Content Vape With All Flavor E-liquids
Normal Nicotine Content Vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Normal Nicotine Content Vape With Tobacco E-liquids
n=29 participants at risk
Normal nicotine content vape with tobacco e-liquids
Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With All Flavor E-liquids
Low nicotine content vape with all flavor e-liquids
Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
Low Nicotine Content Vape With Tobacco E-liquids
n=32 participants at risk
Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group
|
|---|---|---|---|---|
|
Psychiatric disorders
Stress/Irritability
|
—
0/0 • Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
|
3.4%
1/29 • Number of events 1 • Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
|
—
0/0 • Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
|
3.1%
1/32 • Number of events 1 • Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
|
|
Infections and infestations
COVID
|
—
0/0 • Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
|
0.00%
0/29 • Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
|
—
0/0 • Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
|
3.1%
1/32 • Number of events 1 • Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
|
Additional Information
Darcy Lockhart, Project Manager I
Wake Forest School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place