CClinicalTrials.gg
CompletedNCT05714982Updated Sep 12, 2025Results posted

Impact of E-cigarette Device Warnings

An interventional study of Label with text health warning and Label with pictorial health warning in Vaping Behaviors, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,369
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The purpose of this randomized clinical trial is to determine whether e-cigarette warnings increase intentions to quit vaping without the unintended consequence of pushing users toward smoking. This trial addresses these issues by evaluating the impact of e-cigarette warnings by randomly assigning vapers to have their devices and refills labeled with control messages, text warnings, or pictorial warnings. Participants will be US adult (ages 21+) vapers. The trial expects \~1,200 participants to complete Visits 1, 3, and 5.

Read the detailed description

This trial will assess the impact of e-cigarette warnings on vapers' devices and refills in a randomized clinical trial.

Recruitment: Vapers will first undergo screening online or call the study center to complete the screening survey over the phone. Trial staff will schedule eligible vapers for 2 in-person visits. For each of the 2 visits, vapers will be asked to bring the vapes and refill materials they plan to use over the next 2 weeks.

Informed Consent: Prior to consenting vapers, trial staff will visually inspect photo identification of vapers to confirm that they are 21 years or older. At the beginning of the first appointment, trial staff will explain the consent form and ask the vaper to read the form. Once the participant has finished reading the form, the trial staff member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form.

Randomization: At the first visit, trial staff will randomly assign participants to one of the three trial arms by using Qualtrics software. Vapers have an equal chance of being randomized to have labels with control, text, or pictorial warnings.

Assessment: Participants will attend 2 in-person appointments at the study office (at Visit 1 and Visit 3 that are spaced 2 weeks apart). The visits will last about 45-60 minutes. At Visit 1 participants will take a survey, have their vape device and refills labeled based on their trial arm, and take another survey. At Visit 3, participants take a survey and have their vape device and refills labeled based on their trial arm. Participants will also be e-mailed 3 more surveys to complete online at home (taken at Visit 2, 4, and 5). Thus participants will take 5 weekly surveys overall.

Detailed description of the intervention: At each in-person appointment, participants will bring in the vapes and refills they plan to use over the next 2 weeks for labeling. While participants are taking the survey, trial staff will label the devices and refills based on their trial arm.

Participants randomized to the text warning arm will have labels with information about the health harms of vaping applied to their vapes and refills. Participants randomized to the pictorial arm will have labels with pictorial images and text about the health harms of vaping. Participants assigned to the control arm will have labels with neutral statements about vaping. Each trial arm will have four labels (two labels for Visit 1 and two additional labels for Visit 3). Trial staff will return labeled vapes and refills in a clear plastic bag with the e-cigarette warning labels applied to a card. Trial investigators developed the text, images, and design of these labels.

The trial staff will instruct participants in all trial arms to vape or not vape as they normally would. At the end of the trial, participants will receive a link to more information about the risks of vaping and tobacco use.

02

Conditions studied

  • Vaping Behaviors

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Keywords

  • Vaping
  • Tobacco use
  • E-cigarette use
03

In context

Vaping

160 studies on the registry are indexed under Vaping; 72 are open to participants now.

This study's enrollment of 1,369 is above the median of 110 across 135 interventional studies indexed under Vaping.

Browse Vaping studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Be 21 years or older
  • Currently vape every day or some days
  • Use an e-cigarette that contains nicotine
  • Be able to attend 2 in-person appointments
  • Be able to bring in e-cigarette device and 2 weeks' worth or refills to 2 in-person appointments
  • Be willing to let us apply a sticker to the device and refill materials
  • Be willing to use only the labeled e-cigarette during the study
  • Be able to complete 3 surveys online at home
  • Be able to read and speak English
  • Be able to complete a survey on a computer without help

Exclusion criteria

Exclusion Criteria:

  • Pregnant people
  • If e-cigarette device cannot be labeled
  • Vapers concurrently enrolled in any research studies about vaping or using other tobacco products
  • Vapers who live in the same household as someone who has enrolled in the study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,369 participants (actual)

Study arms

  • Experimental
    Label with text health warning

    Labels with e-cigarette health warning that include text about health harms of vaping will be applied to participants' vaping devices and refills.

    Other: Label with text health warning

  • Experimental
    Label with pictorial health warning

    Labels with e-cigarette health warning that include the same text about health harms of vaping and corresponding pictorial images will be applied to participants' vaping devices and refills.

    Other: Label with pictorial health warning

  • Other
    Label with neutral statements about vaping

    Labels with neutral statements about vaping will be applied to participants' vaping devices and refills.

    Other: Label with neutral statements about vaping

Interventions

  • OtherLabel with text health warning

    Labels with e-cigarette health warning that include text about health harms of vaping will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 warnings based on their assigned trial arm; at Visit 3, they will get 2 additional warnings based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.

  • OtherLabel with pictorial health warning

    Labels with e-cigarette health warning that include the same text about health harms of vaping and corresponding pictorial images will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 warnings based on their assigned trial arm; at Visit 3, they will get 2 additional warnings based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.

  • OtherLabel with neutral statements about vaping

    Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 statements based on their assigned trial arm; at Visit 3, they will get 2 additional statements based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.

06

What researchers measure

Primary outcomes

  1. Mean Vaping Quit Intentions Score

    The primary outcome is vaping quit intentions measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher quit intentions.

    Time frame: Up to 4 weeks

Secondary outcomes

  1. Mean Knowledge Score

    Knowledge of health harms from vaping will be measured by 5 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score each item for accuracy (correct or incorrect) and average the scores (% correct) for each time point and take an average across the time points. The range for this measure will be 0% to 100%, with higher values indicating more accurate knowledge).

    Time frame: Up to 4 weeks

  2. Mean Cognitive Elaboration Score

    Cognitive elaboration (thinking about the label) will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more cognitive elaboration.

    Time frame: Up to 4 weeks

  3. Mean Perceived Likelihood of Illness Score

    Perceived likelihood of illness from vaping will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visit 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher perceived likelihood.

    Time frame: Up to 4 weeks

  4. Mean Negative Affect Score

    Negative affective reactions to the labels will be measured by 5 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more negative affect.

    Time frame: Up to 4 weeks

  5. Mean Attention Score

    Attention to the labels will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating greater attention.

    Time frame: Up to 4 weeks

  6. Mean Information Seeking Score

    Information seeking about the harms of vaping will be measured by 1 survey item at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score responses (0 times=0, 1-2 times=1.5, 3-5 times=4, 6+ times=6) and take an average across the time points. The range for this measure will be 0 times to 6 times), with higher values indicating more information seeking.

    Time frame: Up to 4 weeks

  7. Mean Number of Conversations in Past Week

    Number of conversations with others about the labels, health harms caused by vaping, and quitting vaping will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 0 times to 100 times, with higher values indicating more conversations.

    Time frame: Up to 4 weeks

  8. Mean Vaping Reinforcement Attitudes Score

    Positive vaping reinforcement attitudes will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). We will take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more positive vaping reinforcement attitudes.

    Time frame: Up to 4 weeks

  9. Mean Uncontrolled Vaping Score

    Subjective uncontrolled vaping (vaping more than the user prefers) will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visit 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating vaping that is more uncontrolled.

    Time frame: Up to 4 weeks

  10. Mean Number of Times Forgoing a Vape in Past Week

    Number of times forgoing a vape in the last week will be measured by 4 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score responses (never=0, 1 time=1, 2 times=2, 3-5 times=4, 6+ times=6), average the items to create a score for each time point, and take an average across the time points. The range for this measure will be 0 times to 6 times, with higher values indicating more forgoing.

    Time frame: Up to 4 weeks

  11. Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks

    Made vaping quit attempt will be measured by 1 survey item (not vaping for 1 day or longer in the last week because they were trying to stop vaping) at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). There will be an additional item (not vaping for 1 day or longer since the start of the study) at 4 weeks (Visit 5). Study investigators will score the items for any quit attempts: 0 (no quit attempts) or 1 (one or more quit attempt across the 4 weeks).

    Time frame: Up to 4 weeks

  12. Percent of Participants Who Successfully Quit Vaping

    Successful quitting of vaping during the trial will be measured by 1 survey item at 1 time point (participants' last survey, usually Visit 5). Study investigators will score the item for successful quitting: 0 (vaping on one or more of the last 7 days) or 1 (no vaping).

    Time frame: At 4 weeks

  13. Mean Inaccurate Risk Perception Score

    Inaccurate risk perception of vaping (believing vaping is the same or more harmful than smoking cigarettes) will be measured by 1 survey item at 5 time points: post-labeling (Visit 1) and 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score the item for accuracy (vaping less harmful than smoking cigarettes=correct; other answers=incorrect) and take an average across the time points. The range for this measure will be 0% (no correct answers) to 100% (all correct answers), with higher values indicating more accurate risk perceptions.

    Time frame: Up to 4 weeks

  14. Mean Stigma Score

    Stigma (expecting the labels will cause social disapproval of vaping) will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more stigma.

    Time frame: Up to 4 weeks

  15. Mean Smoking Quit Intentions Score

    Smoking quit intentions will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The construct will be assessed only among cigarette smokers. The range for this measure will be 1 to 5, with higher values indicating higher intentions.

    Time frame: Up to 4 weeks

  16. Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks

    Made smoking quit attempt will be measured by 1 survey item (not smoking for 1 day or longer in the last week because they were trying to stop smoking) at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). There will be an additional item (not smoking for 1 day or longer since the start of the study) at 4 weeks (Visit 5). Study investigators will score the items for any quit attempts: 0 (no quit attempts) or 1 (at least one quit attempt across the 4 weeks).

    Time frame: Up to 4 weeks

07

Results

Posted Sep 12, 2025

Participant flow

Participant flow — Overall Study
MilestoneLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Started456457456
Completed454452452
Not completed254

Outcome measures

PrimaryMean Vaping Quit Intentions Score

The primary outcome is vaping quit intentions measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher quit intentions.

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Vaping Quit Intentions Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Vaping Quit Intentions Score2.5 ± 1.32.5 ± 1.12.2 ± 1.0
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = <.001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .78
SecondaryMean Knowledge Score

Knowledge of health harms from vaping will be measured by 5 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score each item for accuracy (correct or incorrect) and average the scores (% correct) for each time point and take an average across the time points. The range for this measure will be 0% to 100%, with higher values indicating more accurate knowledge).

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Knowledge Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Knowledge Score0.6 ± 0.30.6 ± 0.30.4 ± 0.3
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = <.001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .66
SecondaryMean Cognitive Elaboration Score

Cognitive elaboration (thinking about the label) will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more cognitive elaboration.

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Cognitive Elaboration Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Cognitive Elaboration Score2.7 ± 0.92.9 ± 0.92.0 ± 0.8
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = <.001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = <.001
SecondaryMean Perceived Likelihood of Illness Score

Perceived likelihood of illness from vaping will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visit 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher perceived likelihood.

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Perceived Likelihood of Illness Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Perceived Likelihood of Illness Score3.1 ± 0.83.1 ± 0.82.9 ± 0.9
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = .001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .95
SecondaryMean Negative Affect Score

Negative affective reactions to the labels will be measured by 5 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more negative affect.

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Negative Affect Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Negative Affect Score2.1 ± 0.92.3 ± 1.01.4 ± 0.6
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = <.001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = <.001
SecondaryMean Attention Score

Attention to the labels will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating greater attention.

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Attention Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Attention Score3.1 ± 0.93.3 ± 0.92.8 ± 0.9
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = <.0001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = <.001
SecondaryMean Information Seeking Score

Information seeking about the harms of vaping will be measured by 1 survey item at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score responses (0 times=0, 1-2 times=1.5, 3-5 times=4, 6+ times=6) and take an average across the time points. The range for this measure will be 0 times to 6 times), with higher values indicating more information seeking.

Time frame:
Up to 4 weeks
Reported as:
Mean · number of times sought information
Mean Information Seeking Score
number of times sought informationLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Information Seeking Score1.3 ± 1.31.4 ± 1.30.8 ± 1.0
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = <.001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .4
SecondaryMean Number of Conversations in Past Week

Number of conversations with others about the labels, health harms caused by vaping, and quitting vaping will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 0 times to 100 times, with higher values indicating more conversations.

Time frame:
Up to 4 weeks
Reported as:
Mean · number of conversations
Mean Number of Conversations in Past Week
number of conversationsLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Number of Conversations in Past Week1.5 ± 2.21.7 ± 2.11.2 ± 1.8
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = .03
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .4
SecondaryMean Vaping Reinforcement Attitudes Score

Positive vaping reinforcement attitudes will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). We will take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more positive vaping reinforcement attitudes.

Time frame:
Up to 4 weeks
Reported as:
Mean · units on a scale
Mean Vaping Reinforcement Attitudes Score
units on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Vaping Reinforcement Attitudes Score4.1 ± 0.84.1 ± 0.84.2 ± 0.8
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = .61
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .68
SecondaryMean Uncontrolled Vaping Score

Subjective uncontrolled vaping (vaping more than the user prefers) will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visit 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating vaping that is more uncontrolled.

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Uncontrolled Vaping Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Uncontrolled Vaping Score2.4 ± 0.92.4 ± 1.02.3 ± 1.0
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = .4
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .5
SecondaryMean Number of Times Forgoing a Vape in Past Week

Number of times forgoing a vape in the last week will be measured by 4 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score responses (never=0, 1 time=1, 2 times=2, 3-5 times=4, 6+ times=6), average the items to create a score for each time point, and take an average across the time points. The range for this measure will be 0 times to 6 times, with higher values indicating more forgoing.

Time frame:
Up to 4 weeks
Reported as:
Mean · number of times forgoing a vape
Mean Number of Times Forgoing a Vape in Past Week
number of times forgoing a vapeLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Number of Times Forgoing a Vape in Past Week1.7 ± 1.61.7 ± 1.51.3 ± 1.4
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = .001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .9
SecondaryPercent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks

Made vaping quit attempt will be measured by 1 survey item (not vaping for 1 day or longer in the last week because they were trying to stop vaping) at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). There will be an additional item (not vaping for 1 day or longer since the start of the study) at 4 weeks (Visit 5). Study investigators will score the items for any quit attempts: 0 (no quit attempts) or 1 (one or more quit attempt across the 4 weeks).

Time frame:
Up to 4 weeks
Reported as:
Count of participants · Participants
Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks
ParticipantsLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks217204211
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · Odds ratio (or): .9 · 95% CI .73 to 1.2
  • Label With Text Health Warning vs Label With Pictorial Health Warning · Odds ratio (or): .9 · 95% CI .69 to 1.2
SecondaryPercent of Participants Who Successfully Quit Vaping

Successful quitting of vaping during the trial will be measured by 1 survey item at 1 time point (participants' last survey, usually Visit 5). Study investigators will score the item for successful quitting: 0 (vaping on one or more of the last 7 days) or 1 (no vaping).

Time frame:
At 4 weeks
Reported as:
Number · percentage of participants
Percent of Participants Who Successfully Quit Vaping
percentage of participantsLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Percent of Participants Who Successfully Quit Vaping7.27.43.7
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · Odds ratio (or): .5 · 95% CI .3 to .9
  • Label With Text Health Warning vs Label With Pictorial Health Warning · Odds ratio (or): 1 · 95% CI .6 to 1.7
SecondaryMean Inaccurate Risk Perception Score

Inaccurate risk perception of vaping (believing vaping is the same or more harmful than smoking cigarettes) will be measured by 1 survey item at 5 time points: post-labeling (Visit 1) and 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score the item for accuracy (vaping less harmful than smoking cigarettes=correct; other answers=incorrect) and take an average across the time points. The range for this measure will be 0% (no correct answers) to 100% (all correct answers), with higher values indicating more accurate risk perceptions.

Time frame:
Up to 4 weeks
Reported as:
Mean · proportion of correct answers
Mean Inaccurate Risk Perception Score
proportion of correct answersLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Inaccurate Risk Perception Score0.42 ± 0.420.44 ± 0.430.48 ± 0.43
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = .02
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .5
SecondaryMean Stigma Score

Stigma (expecting the labels will cause social disapproval of vaping) will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more stigma.

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Stigma Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Stigma Score1.9 ± 0.82.0 ± 0.91.6 ± 0.7
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = <.001
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = .004
SecondaryMean Smoking Quit Intentions Score

Smoking quit intentions will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The construct will be assessed only among cigarette smokers. The range for this measure will be 1 to 5, with higher values indicating higher intentions.

Time frame:
Up to 4 weeks
Reported as:
Mean · score on a scale
Mean Smoking Quit Intentions Score
score on a scaleLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Mean Smoking Quit Intentions Score2.4 ± 0.92.5 ± 0.92.3 ± 0.9
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · General linear model · p = 0.3
  • Label With Text Health Warning vs Label With Pictorial Health Warning · General linear model · p = 0.5
SecondaryPercent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks

Made smoking quit attempt will be measured by 1 survey item (not smoking for 1 day or longer in the last week because they were trying to stop smoking) at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). There will be an additional item (not smoking for 1 day or longer since the start of the study) at 4 weeks (Visit 5). Study investigators will score the items for any quit attempts: 0 (no quit attempts) or 1 (at least one quit attempt across the 4 weeks).

Time frame:
Up to 4 weeks
Reported as:
Number · percentage of participants
Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks
percentage of participantsLabel With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About Vaping
Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks54.367.963.1
Statistical analysis
  • Label With Text Health Warning vs Label With Neutral Statements About Vaping · Odds ratio (or): 1.4 · 95% CI .99 to 2.1
  • Label With Text Health Warning vs Label With Pictorial Health Warning · Odds ratio (or): 1.8 · 95% CI 1.2 to 2.6

Adverse events

Collected over From the time of signing informed consent, through study completion, a total of up to 4 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Label With Text Health Warning0/456 (0%)0/456 (0%)0/456 (0%)
Label With Pictorial Health Warning0/457 (0%)0/457 (0%)0/457 (0%)
Label With Neutral Statements About Vaping0/456 (0%)0/456 (0%)0/456 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)Label With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About VapingTotal
21-29 years133130141404
30-39 years170159166495
40-49 years10010095295
50+ years536854175
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Label With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About VapingTotal
Female193197208598
Male249237221707
Nonbinary/Another gender14232764
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Label With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About VapingTotal
American Indian or Alaskan Native54312
Asian542539118
Black or African American787774229
Hispanic325146129
Middle Eastern or North African28212
Native Hawaiian or other Pacific Islander1438
White194196183573
Multiracial or another race or ethnicity9091106287
Missing0101
Region of Enrollment
Region of Enrollment(participants)Label With Text Health WarningLabel With Pictorial Health WarningLabel With Neutral Statements About VapingTotal
United States4564574561369
08

Study locations

1 site
  • Ewald & Wasserman Research Consultants, LLC
    San Francisco, California 94104, United States
09

References and documents

Study documents

  • Study protocol · Jul 8, 2025
  • Statistical analysis plan · Jun 24, 2024
  • Informed consent form · Aug 11, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The trial investigators will produce a de-identified dataset and codebook for sharing with external investigators, making use of the UNC Dataverse digital data repository (dataverse.unc.edu) hosted by the Odum Institute Data Archive.

Supporting information: Sap, Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05714982
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Feb 6, 2023
Start date
Feb 23, 2023
Primary completion
Jul 23, 2024
Completion
Jul 23, 2024
Results posted
Sep 12, 2025
Last update
Sep 12, 2025

Study contacts

Noel Brewer, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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