Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05714982
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2023-01-24
Brief Title:
Impact of E-cigarette Device Warnings
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Randomized Clinical Trial Evaluating the Impact of E-cigarette Device Warnings
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1200 participants to complete Visits 1 3 and 5
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA048390 | NIH | None | httpsreporternihgovquickSearchR01DA048390 |