NCT05714982

Impact of E-cigarette Device Warnings

Completed NA Results posted Last updated 12 September 2025

What this trial tests

NA trial testing Label with text health warning in Vaping Behaviors in 1,369 participants. Completed in 23 July 2024.

Timeline

23 February 2023

Primary endpoint
23 July 2024

23 July 2024

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,369
Start date	23 February 2023
Primary completion	23 July 2024
Estimated completion	23 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Label with text health warning
• Label with pictorial health warning
• Label with neutral statements about vaping

Conditions studied

• Vaping Behaviors — all drugs for Vaping Behaviors →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

21 and older, any sex, with Vaping Behaviors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Vaping Quit Intentions Score Primary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	2.5	± 1.3
Label With Pictorial Health Warning	2.5	± 1.1
Label With Neutral Statements About Vaping	2.2	± 1.0

Mean Knowledge Score Secondary · Up to 4 weeks

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).

Group	Value	95% CI
Label With Text Health Warning	0.6	± 0.3
Label With Pictorial Health Warning	0.6	± 0.3
Label With Neutral Statements About Vaping	0.4	± 0.3

Mean Cognitive Elaboration Score Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	2.7	± 0.9
Label With Pictorial Health Warning	2.9	± 0.9
Label With Neutral Statements About Vaping	2.0	± 0.8

Mean Perceived Likelihood of Illness Score Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	3.1	± 0.8
Label With Pictorial Health Warning	3.1	± 0.8
Label With Neutral Statements About Vaping	2.9	± 0.9

Mean Negative Affect Score Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	2.1	± 0.9
Label With Pictorial Health Warning	2.3	± 1.0
Label With Neutral Statements About Vaping	1.4	± 0.6

Mean Attention Score Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	3.1	± 0.9
Label With Pictorial Health Warning	3.3	± 0.9
Label With Neutral Statements About Vaping	2.8	± 0.9

Mean Information Seeking Score Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	1.3	± 1.3
Label With Pictorial Health Warning	1.4	± 1.3
Label With Neutral Statements About Vaping	0.8	± 1.0

Mean Number of Conversations in Past Week Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	1.5	± 2.2
Label With Pictorial Health Warning	1.7	± 2.1
Label With Neutral Statements About Vaping	1.2	± 1.8

Mean Vaping Reinforcement Attitudes Score Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	4.1	± 0.8
Label With Pictorial Health Warning	4.1	± 0.8
Label With Neutral Statements About Vaping	4.2	± 0.8

Mean Uncontrolled Vaping Score Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	2.4	± 0.9
Label With Pictorial Health Warning	2.4	± 1.0
Label With Neutral Statements About Vaping	2.3	± 1.0

Mean Number of Times Forgoing a Vape in Past Week Secondary · Up to 4 weeks

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.

Group	Value	95% CI
Label With Text Health Warning	1.7	± 1.6
Label With Pictorial Health Warning	1.7	± 1.5
Label With Neutral Statements About Vaping	1.3	± 1.4

Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks Secondary · Up to 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).

Group	Value	95% CI
Label With Text Health Warning	217
Label With Pictorial Health Warning	204
Label With Neutral Statements About Vaping	211

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.