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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

Visit 6 approximately 4 weeks after baseline

Results posted on

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

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

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

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 baseline

Population: 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

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 baseline

Population: 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

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 baseline

Population: 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

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: Baseline

Population: 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

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 baseline

Population: 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

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 baseline

Population: 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

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 baseline

Population: 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

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 baseline

Population: 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

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 baseline

Population: 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

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

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

Normal Nicotine Content Vape With Tobacco E-liquids

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Low Nicotine Content Vape With All Flavor E-liquids

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

Low Nicotine Content Vape With Tobacco E-liquids

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 3367166182

Results disclosure agreements

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