Vaping BehaviorsNCT07737080
The Villainous Vape: Advancing Vaping Prevention Among Adolescents Through a Comic Book
A study testing Health Impacts of E-cigarettes, Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping and The Villainous Vape in people with Vaping Behaviors, run by University of Rochester at 1 site in United States.
Trial summary
This is a randomized controlled trial to assess the feasibility, acceptability, and preliminary impact of The Villainous Vape, a vaping prevention comic book, among adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping Behaviors
- What is being tested?
- Health Impacts of E-cigarettes, Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping and The Villainous Vape
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Know how to read and speak English and/or Spanish
- Be at least 12 but no greater than 17 years old
- Be willing to complete three study visits over Zoom or a phone call
- Live in Orleans County, New York
Who cannot join
- A household member participating in the study
- Living outside of Orleans County, New York
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
Francisco Cartujano, MD, 585-353-0035, Francisco_Cartujano@URMC.Rochester.edu
About this study
This is a randomized controlled trial to assess the feasibility, acceptability, and preliminary impact of The Villainous Vape, a vaping prevention comic book, among adolescents.
- Conditions
- Vaping Behaviors
- Being tested
- Health Impacts of E-cigarettes, Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping, The Villainous Vape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Impacts of E-cigarettesBehavioural
Health Impacts of E-cigarettes is a one-page educational flyer that outlines the impact of using electronic cigarettes and what is being done to mitigate youth vaping. The flyer reviews the dangers of nicotine delivery devices, lung damage, and how to stay safe in the event of social exposure to vaping. Health Impacts of E-cigarettes was developed by the U.S. Food and Drug Administration.
Mind Matters: The Body's Response to Nicotine, Tobacco, and VapingBehavioural
Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping is a five-page educational brochure that utilizes an illustrative approach to sharing basic information about nicotine and tobacco products. The brochure focuses on the physiological effect of these products, health effects, addiction, and key statistics. Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping was developed by the U.S. National Institute on Drug Abuse.
The Villainous VapeBehavioural
The Villainous Vape is an eleven-page comic book that follows Daniel, a high school student who gets addicted to vaping and is hospitalized in the intensive care unit because he develops a lung disease. Support from friends and family helps Daniel make the decision to quit vaping. Throughout the comic, readers are exposed to various vaping-related facts and statistics.
| Study group | Role | What they receive |
|---|---|---|
| Health Impacts of E-cigarettes | Active comparator | Not described Receives: Behavioral: Health Impacts of E-cigarettes |
| Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping | Active comparator | Not described Receives: Behavioral: Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping |
| The Villainous Vape | Experimental | Not described Receives: Behavioral: The Villainous Vape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Of Participants Who Complete the Month 3 Assessment.
The percentage will be calculated as the number of participants who complete the Month 3 assessment divided by the total number of enrolled participants.
Measured: Month 3
Percentage Of Participants Who Are Satisfied With Their Assigned Intervention at Month 3
All participants will be asked the following question at Month 3: "How satisfied are you with the assigned intervention?" Responses will be collected using a 5-item Likert scale. The percentage of participants who are satisfied with their assigned intervention at Month 3 will be calculated as the number of participants who respond "satisfied" or "extremely satisfied," divided by the total number of participants in each group.
Measured: Month 3
Percentage Of Participants With Reduced Susceptibility To Future Vaping
Susceptibility to future vaping will be assessed using the susceptibility to e-cigarettes scale. The scale consists of three questions: 1) Have you ever been curious about using e-cigarettes? 2) Do you think you will use e-cigarettes in the next year? 3) If one of your best friends were to offer you an e-cigarette, would you use it? The questions use a 4-point Likert scale ranging from not at all curious (1) to very curious (4) for question one and definitely not (1) to definitely yes (4) for questions two and three. Participants who provide a response other than "not all curious" or "definitely not" will be considered "susceptible". The percentage will be calculated as the number of participants who demonstrate a change from "susceptible" at baseline to "not susceptible" at Month 3, divided by the total number of participants in each group.
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaping BehaviorsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Cartujano, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737080
- Sponsor's protocol ID
- STUDY00011905
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Villainous Vape: Advancing Vaping Prevention Among Adolescents Through a Comic Book
- ClinicalTrials.gov ID
- NCT07737080
- Acronym / sponsor ID
- STUDY00011905
- Conditions
- Vaping Behaviors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Jul 2026 (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 is a randomized controlled trial to assess the feasibility, acceptability, and preliminary impact of The Villainous Vape, a vaping prevention comic book, among adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Impacts of E-cigarettes | Active comparator | Behavioral: Health Impacts of E-cigarettes |
| Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping | Active comparator | Behavioral: Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping |
| The Villainous Vape | Experimental | Behavioral: The Villainous Vape |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Know how to read and speak English and/or Spanish
- Be at least 12 but no greater than 17 years old
- Be willing to complete three study visits over Zoom or a phone call
- Live in Orleans County, New York
Key exclusion criteria (2 listed)
- A household member participating in the study
- Living outside of Orleans County, New York
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 |
|---|---|---|
| Health Impacts of E-cigarettesHealth Impacts of E-cigarettes is a one-page educational flyer that outlines the impact of using electronic cigarettes and what is being done to mitigate youth vaping. The flyer reviews the dangers of nicotine delivery devices, lung damage, and how to stay safe in the event of social exposure to vaping. Health Impacts of E-cigarettes was developed by the U.S. Food and Drug Administration. | Behavioural | Health Impacts of E-cigarettes |
| Mind Matters: The Body's Response to Nicotine, Tobacco, and VapingMind Matters: The Body's Response to Nicotine, Tobacco, and Vaping is a five-page educational brochure that utilizes an illustrative approach to sharing basic information about nicotine and tobacco products. The brochure focuses on the physiological effect of these products, health effects, addiction, and key statistics. Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping was developed by the U.S. National Institute on Drug Abuse. | Behavioural | Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping |
| The Villainous VapeThe Villainous Vape is an eleven-page comic book that follows Daniel, a high school student who gets addicted to vaping and is hospitalized in the intensive care unit because he develops a lung disease. Support from friends and family helps Daniel make the decision to quit vaping. Throughout the comic, readers are exposed to various vaping-related facts and statistics. | Behavioural | The Villainous Vape |
Primary outcome
Percentage Of Participants Who Complete the Month 3 Assessment.
Time frame: Month 3
The percentage will be calculated as the number of participants who complete the Month 3 assessment divided by the total number of enrolled participants.
Percentage Of Participants Who Are Satisfied With Their Assigned Intervention at Month 3
Time frame: Month 3
All participants will be asked the following question at Month 3: "How satisfied are you with the assigned intervention?" Responses will be collected using a 5-item Likert scale. The percentage of participants who are satisfied with their assigned intervention at Month 3 will be calculated as the number of participants who respond "satisfied" or "extremely satisfied," divided by the total number of participants in each group.
Percentage Of Participants With Reduced Susceptibility To Future Vaping
Time frame: Baseline to Month 3
Susceptibility to future vaping will be assessed using the susceptibility to e-cigarettes scale. The scale consists of three questions: 1) Have you ever been curious about using e-cigarettes? 2) Do you think you will use e-cigarettes in the next year? 3) If one of your best friends were to offer you an e-cigarette, would you use it? The questions use a 4-point Likert scale ranging from not at all curious (1) to very curious (4) for question one and definitely not (1) to definitely yes (4) for questions two and three. Participants who provide a response other than "not all curious" or "definitely not" will be considered "susceptible". The percentage will be calculated as the number of participants who demonstrate a change from "susceptible" at baseline to "not susceptible" at Month 3, divided by the total number of participants in each group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Impacts of E-cigarettes, Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping and The Villainous Vape in people with Vaping Behaviors, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Cartujano, MD ((585) 273-1646, Francisco_Cartujano@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Of Participants Who Complete the Month 3 Assessment. (time frame: Month 3). The study lists 3 primary outcomes in all. 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 30 Jul 2026.