VapingVapechatNCT06003439
Vaping Prevention and Vaping in Youth (Vapechat)
A study testing Virtual Reality Program and VR Program in people with Vaping and Smoking Cessation, run by Boston University at 1 site in United States.
Trial summary
Many youth are addicted to nicotine due to increased nicotine vaping (e.g., e-cigarettes). Unfortunately, there are no effective interventions to help teens quit vaping. In addition, existing vaping prevention programs have limited effectiveness because teens have reported that existing available interventions are out… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping, Smoking Cessation
- What is being tested?
- Virtual Reality Program and VR Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 7 Jun 2024
- Phase
- Interventional
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students enrolled at Everett and Quincy High Schools (freshmen, sophomores, juniors, and seniors).
- Students in Health class
- Child assents
Who cannot join
- Teacher indicates that participation is not appropriate for the student (e.g., severe mental illness; visual or auditory disability; medical issue)
- Parent(s)/guardian(s) opt student out of the study.
- Prone to motion sickness or seizures.
- Visual impairments that would preclude playing VR or otherwise unable to use VR device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University, Goldman School of Dental Medicine
Boston, Massachusetts, 02118
About this study
Official title: Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youth
Many youth are addicted to nicotine due to increased nicotine vaping (e.g., e-cigarettes). Unfortunately, there are no effective interventions to help teens quit vaping. In addition, existing vaping prevention programs have limited effectiveness because teens have reported that existing available interventions are out of touch with teen's culture and are not appealing to the intended audience. Therefore, to be effective, a vaping intervention must be acceptable, appealing, and engaging to teens, and most importantly, it should be designed to be channeled into an existing infrastructure such as the school setting.
The investigators' research group has designed a vaping prevention and cessation intervention that is implemented as a VR game for high school teens. The overall objective of this research is to assess the acceptability, feasibility, and preliminary efficacy of the VR experience among high school students in two high schools in Boston.
Read the detailed description
The investigators will conduct a randomized trial of high school students (freshman to seniors) in the Boston area to determine feasibility, satisfaction, and preliminary efficacy of the VR-based vaping cessation and prevention game. Students will be randomized by class to either receive the Virtual Reality (VR) program (experimental condition) or control condition (questionnaire assessment only). There will be three VR sessions played at school during a health class. Participants in the VR condition will also engage in a gamified home-based component on their smartphone, in order to reinforce skills learned in the school-based VR experience.
Seven high school classes across two high schools will be randomized to VR intervention or assessment only. Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator. Participants will be enrolled in the study for approximately 6 weeks. In the first 3 weeks, participants will engage in the VR game experience once per week during their classes. In the fourth and fifth week, participants may make up any VR game session that they missed because of absence (e.g., illness). At week 6, participants will complete the follow-up questionnaire assessments.
- Conditions
- Vaping, Smoking Cessation
- Being tested
- Virtual Reality Program, VR Program
- Keywords
- Virtual reality (VR), High School Students
- Medical subject headings
- Vaping, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ProgramBehavioural
Also called VR Program
Behavioral: Virtual Reality Program The VR Program will be pre-installed on Meta Quest 2 headsets, which will be donned by students as a class to experience the intervention for approximately the length of one school class period (approximately 30-40 minutes). Each participant will experience the program once a week for 3 weeks. Participants who missed a week will complete the program by the 4th or 5th week.
VR ProgramBehavioural
VR program participants will be able to download a mobile app that complements and reinforces the school-based VR session.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Program | Experimental | Students in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program. Receives: Behavioral: Virtual Reality Program; Behavioral: VR Program |
| Assessment Only | No intervention | Students in classrooms randomized to this group will not receive the VR intervention but will complete questionnaire assessment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement with the VR program
Experimental condition arm. Playing time in minutes objectively measured by the program software; higher values mean a better outcome
Measured: 5 weeks
Satisfaction with the VR game
Experimental condition arm. Self-report star rating of the VR game (1 to 5 stars); higher values mean a better outcome
Measured: 5 weeks
Awareness of vaping
Experimental condition arm. Self-report awareness adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Measured: 5 weeks
Knowledge of vaping
Experimental condition arm Self-report knowledge adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Measured: 5 weeks
Attitudes towards vaping
Experimental condition arm. Self-report attitudes towards vaping adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Measured: 5 weeks
Intention to change
Experimental condition arm. Self-report intention to change vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Measured: 5 weeks
Help seeking
Experimental condition arm. Self-report help seeking for vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Measured: 5 weeks
Gameplay experience and satisfaction
Experimental condition arm. Scores on a scale assessing the gameplay experience. Score range 1 - 4; higher values mean a better outcome
Measured: 5 weeks
Secondary outcomes (16)
Quit vaping attempts
Proportion of participants who have made one or more attempts to quit vaping for at least 24 hours
Measured: 5 weeks
Past 30-days vaping frequency
Proportion of participants who have vaped '0', or '1-2', or '3-5', or '6-9', or '10-19', or '20-30' days in the past 30-days
Measured: 5 weeks
Past 7-days vaping frequency
Proportion of participants who have vaped '0', or '1-2', or '3-4', or '5-6', or '7' days in the past 7-days
Measured: 5 weeks
Frequency of current vaping
Proportion of participants who currently vape 'not at all', or 'some days', or 'most days', or 'every day'
Measured: 5 weeks
Motivation to quit (or avoid) vaping within the next 30-days
Proportion of participants who are seriously thinking about quitting (or avoid) vaping within the next 30-days
Measured: 5 weeks
Motivation to quit (or avoid) vaping
Scores on a scale assessing motivation to quit (or avoid) vaping. Score range 1 - 10; higher values mean a better outcome
Measured: 5 weeks
Intention to try vaping (or quit vaping)
Proportion of participants who are 'probably not' or 'definitely not' thinking of vaping in the next 30- days
Measured: 5 weeks
Confidence in avoiding vaping
Scores on a single item assessing confidence in avoiding vaping within 30-days. Scores range 1-10, higher values mean a better outcome
Measured: 5 weeks
Self-efficacy to resist vaping
Scores on the adapted smoking abstinence self-efficacy questionnaire for adolescents. Scores range 0-24 , higher values mean a better outcome
Measured: 5 weeks
Resilience
Scores on a brief resilience scale. Scores range 0-3 , higher values mean a worse outcome
Measured: 5 weeks
Positive affect
Scores on the Pediatric Positive Affect (PROMIS) scale. Scores range 8-40, higher values mean a better outcome
Measured: 5 weeks
Negative affect
Scores on the Negative Affect for Children scale Scores range 10-50, higher values mean a worse outcome
Measured: 5 weeks
Tolerability of the VR game
Experimental condition arm Scores on the VR sickness questionnaire. Scores range 1-4, higher values mean a worse outcome
Measured: 5 weeks
Intention to connect with vaping cessation resources
Scores on a single item assessing intentions to connect with vaping cessation resources. Scores range 1-10, higher values mean a better outcome
Measured: 5 weeks
Emotion Regulation and Coping
Scores on the Adolescent-Coping Orientation for Problem Experience (A-COPE). Scores range 6-30, higher values mean a better outcome
Measured: 5 weeks
Connection with vaping cessation resources
Proportion of participants who have made contact with any vaping cessation resources during the study
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start4 Apr 2024
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VapingStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Model description
- Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Belinda Borrelli, PhD, Principal investigator, Boston University, Goldman School of Dental Medicine, Center for Behavioral Science Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003439
- Sponsor's protocol ID
- H-43102
- Acronym
- Vapechat
- Status last verified
- Jun 2024
- First submitted
- 15 Aug 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borrelli B, Weinstein D, Endrighi R, Ling N, Koval K, Quintiliani LM, Konieczny K. Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youths: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 15;14:e71961. doi: 10.2196/71961.
PubMed 40278000
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youth
- ClinicalTrials.gov ID
- NCT06003439
- Acronym / sponsor ID
- Vapechat / H-43102
- Conditions
- Vaping, Smoking Cessation
- Keywords
- Virtual reality (VR), High School Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 22 Aug 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.
Many youth are addicted to nicotine due to increased nicotine vaping (e.g., e-cigarettes). Unfortunately, there are no effective interventions to help teens quit vaping. In addition, existing vaping prevention programs have limited effectiveness because teens have reported that existing available interventions are out of touch with teen's culture and are not appealing to the intended audience. Therefore, to be effective, a vaping intervention must be acceptable, appealing, and engaging to teens, and most importantly, it should be designed to be channeled into an existing infrastructure such as the school setting.
The investigators' research group has designed a vaping prevention and cessation intervention that is implemented as a VR game for high school teens. The overall objective of this research is to assess the acceptability, feasibility, and preliminary efficacy of the VR experience among high school students in two high schools in Boston.
Detailed description
The investigators will conduct a randomized trial of high school students (freshman to seniors) in the Boston area to determine feasibility, satisfaction, and preliminary efficacy of the VR-based vaping cessation and prevention game. Students will be randomized by class to either receive the Virtual Reality (VR) program (experimental condition) or control condition (questionnaire assessment only). There will be three VR sessions played at school during a health class. Participants in the VR condition will also engage in a gamified home-based component on their smartphone, in order to reinforce skills learned in the school-based VR experience.
Seven high school classes across two high schools will be randomized to VR intervention or assessment only. Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator. Participants will be enrolled in the study for approximately 6 weeks. In the first 3 weeks, participants will engage in the VR game experience once per week during their classes. In the fourth and fifth week, participants may make up any VR game session that they missed because of absence (e.g., illness). At week 6, participants will complete the follow-up questionnaire assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Program | Experimental | Behavioral: Virtual Reality Program, Behavioral: VR ProgramStudents in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program. |
| Assessment Only | No intervention | –Students in classrooms randomized to this group will not receive the VR intervention but will complete questionnaire assessment only. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Students enrolled at Everett and Quincy High Schools (freshmen, sophomores, juniors, and seniors).
- Students in Health class
- Child assents
Key exclusion criteria (4 listed)
- Teacher indicates that participation is not appropriate for the student (e.g., severe mental illness; visual or auditory disability; medical issue)
- Parent(s)/guardian(s) opt student out of the study.
- Prone to motion sickness or seizures.
- Visual impairments that would preclude playing VR or otherwise unable to use VR device.
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 |
|---|---|---|
| Virtual Reality ProgramAlso: VR ProgramBehavioral: Virtual Reality Program The VR Program will be pre-installed on Meta Quest 2 headsets, which will be donned by students as a class to experience the intervention for approximately the length of one school class period (approximately 30-40 minutes). Each participant will experience the program once a week for 3 weeks. Participants who missed a week will complete the program by the 4th or 5th week. | Behavioural | Virtual Reality Program |
| VR ProgramVR program participants will be able to download a mobile app that complements and reinforces the school-based VR session. | Behavioural | Virtual Reality Program |
Primary outcome
Engagement with the VR program
Time frame: 5 weeks
Experimental condition arm. Playing time in minutes objectively measured by the program software; higher values mean a better outcome
Satisfaction with the VR game
Time frame: 5 weeks
Experimental condition arm. Self-report star rating of the VR game (1 to 5 stars); higher values mean a better outcome
Awareness of vaping
Time frame: 5 weeks
Experimental condition arm. Self-report awareness adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Knowledge of vaping
Time frame: 5 weeks
Experimental condition arm Self-report knowledge adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Attitudes towards vaping
Time frame: 5 weeks
Experimental condition arm. Self-report attitudes towards vaping adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Intention to change
Time frame: 5 weeks
Experimental condition arm. Self-report intention to change vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Help seeking
Time frame: 5 weeks
Experimental condition arm. Self-report help seeking for vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Gameplay experience and satisfaction
Time frame: 5 weeks
Experimental condition arm. Scores on a scale assessing the gameplay experience. Score range 1 - 4; higher values mean a better outcome
16 secondary outcomes
Quit vaping attempts
Time frame: 5 weeks
Past 30-days vaping frequency
Time frame: 5 weeks
Past 7-days vaping frequency
Time frame: 5 weeks
Frequency of current vaping
Time frame: 5 weeks
Motivation to quit (or avoid) vaping within the next 30-days
Time frame: 5 weeks
Motivation to quit (or avoid) vaping
Time frame: 5 weeks
Intention to try vaping (or quit vaping)
Time frame: 5 weeks
Confidence in avoiding vaping
Time frame: 5 weeks
Self-efficacy to resist vaping
Time frame: 5 weeks
Resilience
Time frame: 5 weeks
Positive affect
Time frame: 5 weeks
Negative affect
Time frame: 5 weeks
Tolerability of the VR game
Time frame: 5 weeks
Intention to connect with vaping cessation resources
Time frame: 5 weeks
Emotion Regulation and Coping
Time frame: 5 weeks
Connection with vaping cessation resources
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 40278000Borrelli B, Weinstein D, Endrighi R, Ling N, Koval K, Quintiliani LM, Konieczny K. Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youths: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 15;14:e71961. doi: 10.2196/71961.
- 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. This study is not recruiting at the moment.
Belinda Borrelli, PhD principal investigator
Boston University, Goldman School of Dental Medicine, Center for Behavioral Science Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Program and VR Program in people with Vaping and Smoking Cessation, run by Boston University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with the VR program (time frame: 5 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003439, which also lists 1 linked publication.
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 7 Jun 2024.