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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA048390 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Label with text health warning | Experimental | Labels with e-cigarette health warning that include text about health harms of vaping will be applied to participants' vaping devices and refills. |
|
| Label with pictorial health warning | Experimental | 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. |
|
| Label with neutral statements about vaping | Other | Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Label with text health warning | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel Brewer, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewald & Wasserman Research Consultants, LLC | San Francisco | California | 94104 | United States |
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.
The data will be available beginning 12 to 36 months following the primary publication.
To obtain a copy of the dataset and codebook, a research scientist will have to submit a request in writing, identifying themselves and their affiliated institution, indicating what they plan to do with the data, and including assurances that they will not share the data with others without the written permission of the PI. Requestors must already have institutional review board, independent ethics committee, or research ethics board approval as applicable. Requestors must obtain a data use agreement through UNC's Office of Industry Contracting (OIC@unc.edu) to receive the dataset and codebook and agree to acknowledge NIH and the study investigators in any publications resulting from the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| FG001 | 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. 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. 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. |
| FG002 | Label With Neutral Statements About Vaping | Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. Label 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
|
From the time of signing informed consent, through study completion, a total of up to 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | UNC | (919) 966-3282 | ntb@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2025 | Jul 8, 2025 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2024 | Jun 24, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2023 | Jan 29, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004348 | Drug Labeling |
| ID | Term |
|---|---|
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D004349 | Drug Packaging |
| D004345 | Drug Industry |
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|
| Label with pictorial health warning | Other | 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. |
|
| Label with neutral statements about vaping | Other | 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. |
|
| Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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). | Up to 4 weeks |
| 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). | At 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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. | Up to 4 weeks |
| 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). | Up to 4 weeks |
| BG001 | 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. 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. 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. |
| BG002 | Label With Neutral Statements About Vaping | Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. Label 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. 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. 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. |
| OG002 | Label With Neutral Statements About Vaping | Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. Label 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. |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | number of times sought information | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | number of conversations | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | number of times forgoing a vape | Up to 4 weeks |
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| Secondary | 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). | Posted | Count of Participants | Participants | Up to 4 weeks |
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| Secondary | 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). | Posted | Number | percentage of participants | At 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | proportion of correct answers | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 4 weeks |
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| Secondary | 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). | Posted | Number | percentage of participants | Up to 4 weeks |
|
|
|
|
| 0 |
| 456 |
| 0 |
| 456 |
| 0 |
| 456 |
| EG001 | 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. 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. 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. | 0 | 457 | 0 | 457 | 0 | 457 |
| EG002 | Label With Neutral Statements About Vaping | Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. Label 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. | 0 | 456 | 0 | 456 | 0 | 456 |
Not provided
Not provided
| D066192 |
| Manufacturing Industry |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
| D019064 | Product Packaging |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Odds Ratio (OR) |
| .9 |
| 2-Sided |
| 95 |
| .69 |
| 1.2 |
| Superiority |
| Odds Ratio (OR) |
| 1 |
| 2-Sided |
| 95 |
| .6 |
| 1.7 |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Odds Ratio (OR) |
| 1.8 |
| 2-Sided |
| 95 |
| 1.2 |
| 2.6 |
| Superiority |