E Cigarette UsePhase 3NCT05892445
Impact of Aversive Warnings on E-Cigarette Cessation
A Phase 3 study testing Graphic Warning Labels in people with E Cigarette Use, run by University of California, San Diego.
Trial summary
This project aims to evaluate the effectiveness of aversive visual health warnings on e-cigarette cessation among young adults through a randomized controlled trial, as e-cigarette use among this population has been steadily increasing, posing significant public health concerns. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- E Cigarette Use
- What is being tested?
- Graphic Warning Labels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
- Age 18-29 years
- Basic understanding of English
- Not institutionalized
- Currently use e-cigarettes at least once per week
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Aversive Visual Health Warnings on E-Cigarette Cessation Intentions and Behaviors Among Young Adults
This project aims to evaluate the effectiveness of aversive visual health warnings on e-cigarette cessation among young adults through a randomized controlled trial, as e-cigarette use among this population has been steadily increasing, posing significant public health concerns. While traditional tobacco products have long featured health warnings, e-cigarettes lack similarly aversive visual warnings, and this study seeks to inform the development of targeted e-cigarette cessation strategies and contribute to a deeper understanding of how visual health warnings can be utilized to reduce e-cigarette use and ultimately improve public health. The project has three main aims, which include a rigorous assessment of the academic literature on e-cigarette risks and adverse effects to develop evidence-based mock visual health warnings for e-cigarettes; assessing the effectiveness of aversive visual health warnings in increasing intent to cessate e-cigarettes, with a particular focus on individuals who have experienced adverse events; and examining the long-term impacts of visual health warnings on e-cigarette cessation. This study will also investigate the underlying mechanisms that may explain the relationship of the intervention on cessation. To generate visual warnings, the research team will conduct a thorough review of the scientific literature on e-cigarette risks and adverse effects and collaborate with a graphic designer. Experimental warnings will be annotated and categorized in order to understand the influence of different imagery on variations in participant response. The study will be conducted as a randomized controlled trial, recruiting participants through market research firms that will distribute an online survey to their panels of e-cigarette users. Participants will be eligible for inclusion if they are 18-29 years old and currently use e-cigarettes at least once per week. A quota will be included to ensure sufficient responses from individuals who have experienced at least one adverse event related to e-cigarette use in the past 12 months. The intervention group will be exposed to a series of aversive visual health warnings about the potential health risks of e-cigarette use, delivered through the online survey platform, while the control group will not receive any intervention and will complete the same survey as the intervention group. Data will be analyzed using appropriate statistical techniques, including logistic regression and mediation/moderation analysis, to assess the effectiveness of the aversive visual health warnings in reducing e-cigarette use and the moderating effects of prior adverse event experience. Participants will be contacted for follow-up assessments at 3-months post-intervention to investigate the impact of aversive visual health warnings on e-cigarette cessation among young adults, including the moderating effects of prior adverse event experience, and assess the underlying mechanisms that may explain the relationship between the intervention and e-cigarette cessation.
- Conditions
- E Cigarette Use
- Being tested
- Graphic Warning Labels
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graphic Warning LabelsBehavioural
Based on a thorough review of the literature on e-cigarette risks and adverse effects, a graphic designer will be contracted to create ten experimental aversive health warnings related to e-cigarettes. These warnings will be exported as high-quality images and shown to participants in the intervention group prior to questions that obtain data on the primary endpoint.
| Study group | Role | What they receive |
|---|---|---|
| Aversive Visual Health Warnings | Experimental | Study subjects in this arm will be exposed to experimental aversive visual health warnings depicting risks and adverse effects of e-cigarette use. They will answer survey questions about e-cigarette perceptions before and after exposure to health warnings. Receives: Behavioral: Graphic Warning Labels |
| No Warnings | No intervention | Study subjects in this arm will answer the same survey questions about e-cigarette perceptions as those in the experimental arm, but they will not be shown aversive visual health warnings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intent to Cessate Use of E-Cigarettes
Every participant will take a survey with a question that asks about willingness to cease e-cigarettes using the seven-point Motivation To Stop Scale, adapted for e-cigarettes, in order to assess the influence of the intervention.
Measured: Immediately after exposure to intervention
Secondary outcomes (1)
E-Cigarette Cessation Attempt
Participants completing the first survey will be recontacted six months after their completion date to complete a second survey. This survey will ask whether the participant has made an attempt to quit using e-cigarettes, as well as the approximate date of the quit attempt.
Measured: Six months after exposure to intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 May 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E Cigarette UseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Cuomo, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892445
- Sponsor's protocol ID
- 1422045
- Status last verified
- Jun 2024
- First submitted
- 26 May 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The project will generate survey data collected from 1000 young adult e-cigarette users, along with follow-up data from the same participants at 3 months post-intervention. The anonymized survey data and follow-up data will be preserved and shared to facilitate further analysis and replication of the study. The data will include demographics, e-cigarette use patterns, intentions to quit, perceived risk and harm, exposure to health warnings, and experiences with adverse events.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aversive Visual Health Warnings on E-Cigarette Cessation Intentions and Behaviors Among Young Adults
- ClinicalTrials.gov ID
- NCT05892445
- Acronym / sponsor ID
- 1422045
- Conditions
- E Cigarette Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to evaluate the effectiveness of aversive visual health warnings on e-cigarette cessation among young adults through a randomized controlled trial, as e-cigarette use among this population has been steadily increasing, posing significant public health concerns. While traditional tobacco products have long featured health warnings, e-cigarettes lack similarly aversive visual warnings, and this study seeks to inform the development of targeted e-cigarette cessation strategies and contribute to a deeper understanding of how visual health warnings can be utilized to reduce e-cigarette use and ultimately improve public health. The project has three main aims, which include a rigorous assessment of the academic literature on e-cigarette risks and adverse effects to develop evidence-based mock visual health warnings for e-cigarettes; assessing the effectiveness of aversive visual health warnings in increasing intent to cessate e-cigarettes, with a particular focus on individuals who have experienced adverse events; and examining the long-term impacts of visual health warnings on e-cigarette cessation. This study will also investigate the underlying mechanisms that may explain the relationship of the intervention on cessation. To generate visual warnings, the research team will conduct a thorough review of the scientific literature on e-cigarette risks and adverse effects and collaborate with a graphic designer. Experimental warnings will be annotated and categorized in order to understand the influence of different imagery on variations in participant response. The study will be conducted as a randomized controlled trial, recruiting participants through market research firms that will distribute an online survey to their panels of e-cigarette users. Participants will be eligible for inclusion if they are 18-29 years old and currently use e-cigarettes at least once per week. A quota will be included to ensure sufficient responses from individuals who have experienced at least one adverse event related to e-cigarette use in the past 12 months. The intervention group will be exposed to a series of aversive visual health warnings about the potential health risks of e-cigarette use, delivered through the online survey platform, while the control group will not receive any intervention and will complete the same survey as the intervention group. Data will be analyzed using appropriate statistical techniques, including logistic regression and mediation/moderation analysis, to assess the effectiveness of the aversive visual health warnings in reducing e-cigarette use and the moderating effects of prior adverse event experience. Participants will be contacted for follow-up assessments at 3-months post-intervention to investigate the impact of aversive visual health warnings on e-cigarette cessation among young adults, including the moderating effects of prior adverse event experience, and assess the underlying mechanisms that may explain the relationship between the intervention and e-cigarette cessation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aversive Visual Health Warnings | Experimental | Behavioral: Graphic Warning LabelsStudy subjects in this arm will be exposed to experimental aversive visual health warnings depicting risks and adverse effects of e-cigarette use. They will answer survey questions about e-cigarette perceptions before and after exposure to health warnings. |
| No Warnings | No intervention | –Study subjects in this arm will answer the same survey questions about e-cigarette perceptions as those in the experimental arm, but they will not be shown aversive visual health warnings. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graphic Warning LabelsBased on a thorough review of the literature on e-cigarette risks and adverse effects, a graphic designer will be contracted to create ten experimental aversive health warnings related to e-cigarettes. These warnings will be exported as high-quality images and shown to participants in the intervention group prior to questions that obtain data on the primary endpoint. | Behavioural | Aversive Visual Health Warnings |
Primary outcome
Intent to Cessate Use of E-Cigarettes
Time frame: Immediately after exposure to intervention
Every participant will take a survey with a question that asks about willingness to cease e-cigarettes using the seven-point Motivation To Stop Scale, adapted for e-cigarettes, in order to assess the influence of the intervention.
1 secondary outcome
E-Cigarette Cessation Attempt
Time frame: Six months after exposure to intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: Yes. The project will generate survey data collected from 1000 young adult e-cigarette users, along with follow-up data from the same participants at 3 months post-intervention. The anonymized survey data and follow-up data will be preserved and shared to facilitate further analysis and replication of the study. The data will include demographics, e-cigarette use patterns, intentions to quit, perceived risk and harm, exposure to health warnings, and experiences with adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Graphic Warning Labels in people with E Cigarette Use, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphael E Cuomo, PhD (858-822-3552, racuomo@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intent to Cessate Use of E-Cigarettes (time frame: Immediately after exposure to intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.