CannabisNCT07413432
A Virtual Reality Game to Prevent E-cigarette and Cannabis Vaping
A study testing Virtual reality videogame intervention for vaping prevention in people with Cannabis and Vaping, run by Yale University at 1 site in United States.
Trial summary
The goal of this study is to develop and test an adapted version of our virtual reality videogame intervention prototype, Invite Only VR, developed for middle school students, which focuses on e-cigarette and marijuana vaping prevention. The game also includes a focus on emotion regulation and healthy coping skills. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Vaping, Emotion Regulation
- What is being tested?
- Virtual reality videogame intervention for vaping prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2025to 30 Dec 2025
- 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- enrolled at a participating middle school in CT
- speak English
- attending 6th, 7th, or 8th grade
- be willing to play a virtual reality videogame for 45-60 minutes/session
- ability to provide assent or parental/guardian consent
Who cannot join
- Failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: A Virtual Reality Videogame for E-cigarette and Cannabis Prevention in Teens
The goal of this study is to develop and test an adapted version of our virtual reality videogame intervention prototype, Invite Only VR, developed for middle school students, which focuses on e-cigarette and marijuana vaping prevention. The game also includes a focus on emotion regulation and healthy coping skills. To determine the preliminary impact of the intervention, investigators will collect acceptability and feasibility data from 6th-8th grade students across three Connecticut middle schools. Investigators will also collect data on participants' knowledge, harm perceptions, and intentions to vape before and after they have played the videogame intervention.
Read the detailed description
The goal of this project is to develop and evaluate an evidence-based classroom-based e-cigarette and marijuana vaping prevention videogame for 6th to 8th grade students in three CT middle schools. To determine the preliminary impact of the intervention, investigators will measure the following : 1) students who complete the entire intervention (target outcome >90%), 2) acceptability of the intervention among 6th-8th grade students and school administration associated with delivery of the intervention (target outcome >90% report it is acceptable); 3) the intervention will be reported as feasible to implement by school administration(target outcome >90% report it is feasible); 4) students will increase knowledge of marijuana and nicotine vaping harms (target outcome pre-post knowledge and harm perceptions test score will have a statistically significant increase, 5) students will reduce their intentions to vape (target outcome pre-post intentions to vape will have a statistically significant decrease in scores). Findings from this research study will produce the first theory-driven, evidence-based, novel VR videogame intervention focused on both e-cigarette and marijuana vaping in adolescents, a key population that needs engaging interventions designed specifically for them, and will provide acceptability and preliminary efficacy data to inform a larger-scale effectiveness-implementation trial.
- Conditions
- Cannabis, Vaping, Emotion Regulation
- Being tested
- Virtual reality videogame intervention for vaping prevention
- Keywords
- vaping, cannabis, prevention, videogame, virtual reality, adolescents, emotion regulation
- Medical subject headings
- Marijuana Abuse, Vaping, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality videogame intervention for vaping preventionBehavioural
Also called Invite Only VR
Invite Only VR is an immersive virtual reality game designed to help adolescents build knowledge, awareness, and refusal skills around vaping through interactive, story-based social scenarios. The latest version expands its focus to include both nicotine and cannabis vaping, offering players realistic opportunities to navigate peer pressure and practice informed decision-making
| Study group | Role | What they receive |
|---|---|---|
| Invite Only VR Intervention Only Group | Experimental | All participants in the study will play the virtual reality videogame intervention, Invite Only VR. The game was developed for middle school students and focuses on e-cigarette and cannabis vaping prevention. The game also includes content and skill-development related to emotion regulation and healthy coping. Receives: Behavioral: Virtual reality videogame intervention for vaping prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Assessed Using Change in Retention Rates
Feasibility will be measured the number of participants that completed the assigned intervention.
Measured: From enrollment to the end of the last gameplay session, up to 1.5 hrs
Acceptability Assessed Via Self-reported Survey
Acceptability of the intervention is assessed via self-reported survey at the post-gameplay time point using the game experience and satisfaction questionnaire, which is a 12-item scale custom-created for this study with 4-point Likert-type responses ranging from 1 (strongly disagree) to 4 (strongly agree). Total score range 12-42. Higher scores indicate stronger agreement with the statement.
Measured: End of Final Gameplay Session, up to 1.5 hrs
Usability of the Intervention Assessed via Self-Reported Survey
Usability of the intervention will be assessed via self-reported survey at the post-gameplay time point using the System Usability Scale (SUS), which is a 10-item scale with 5-point Likert-type responses ranging from 1 (strongly disagree) to 5 (strongly agree). Total score range 10-50. Higher scores indicate stronger agreement with the statement.
Measured: End of Final Gameplay Session, up to 1.5 hrs
Secondary outcomes (3)
Change in Intentions to Use E-cigarettes from Pre- to Post-Intervention
Changes in intentions to use e-cigarettes will be assessed using the Pierce Susceptibility Measure, at the post-gameplay time point which is a 4-item scale with 4-point Likert-type responses ranging from 1 (Definitely yes) to 4 (Definitely not). Total score range 4-16. Higher scores indicate greater intentions to use e-cigarettes.
Measured: Baseline and immediately following the last gameplay session, up to 1.5 hrs.
Change in Nicotine and Cannabis Harm Perceptions
Change in nicotine and cannabis harm perceptions will be assessed using a 6-item survey created by the research team using a 5-point Likert scale. Total score range is 6-30. Lower scores indicate low harm perceptions.
Measured: Baseline and immediately following the last gameplay session up to 1.5 hrs.
Changes in Nicotine and Cannabis Vape Knowledge
Changes in nicotine and cannabis vape knowledge will be assessed using an 8-item survey created by the research team. Responses include True, False, and I Don't Know.
Measured: Baseline and immediately following the last gameplay session, up to 1.5 hrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start26 Sep 2025
- Primary completion15 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Yale 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group pre-post quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- CT Department of Public Health
- Responsible party
- Sponsor
- Investigators
- Kimberly Hieftje, PhD, Principal investigator, Yale UniversityDeepa Camenga, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413432
- Sponsor's protocol ID
- 2000025177_sub3
- Status last verified
- Feb 2026
- First submitted
- 20 Oct 2025
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality Videogame for E-cigarette and Cannabis Prevention in Teens
- ClinicalTrials.gov ID
- NCT07413432
- Acronym / sponsor ID
- 2000025177_sub3
- Conditions
- Cannabis, Vaping, Emotion Regulation
- Keywords
- vaping, cannabis, prevention, videogame, virtual reality, adolescents, emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- CT Department of Public Health
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 17 Feb 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.
The goal of this study is to develop and test an adapted version of our virtual reality videogame intervention prototype, Invite Only VR, developed for middle school students, which focuses on e-cigarette and marijuana vaping prevention. The game also includes a focus on emotion regulation and healthy coping skills. To determine the preliminary impact of the intervention, investigators will collect acceptability and feasibility data from 6th-8th grade students across three Connecticut middle schools. Investigators will also collect data on participants' knowledge, harm perceptions, and intentions to vape before and after they have played the videogame intervention.
Detailed description
The goal of this project is to develop and evaluate an evidence-based classroom-based e-cigarette and marijuana vaping prevention videogame for 6th to 8th grade students in three CT middle schools. To determine the preliminary impact of the intervention, investigators will measure the following : 1) students who complete the entire intervention (target outcome >90%), 2) acceptability of the intervention among 6th-8th grade students and school administration associated with delivery of the intervention (target outcome >90% report it is acceptable); 3) the intervention will be reported as feasible to implement by school administration(target outcome >90% report it is feasible); 4) students will increase knowledge of marijuana and nicotine vaping harms (target outcome pre-post knowledge and harm perceptions test score will have a statistically significant increase, 5) students will reduce their intentions to vape (target outcome pre-post intentions to vape will have a statistically significant decrease in scores). Findings from this research study will produce the first theory-driven, evidence-based, novel VR videogame intervention focused on both e-cigarette and marijuana vaping in adolescents, a key population that needs engaging interventions designed specifically for them, and will provide acceptability and preliminary efficacy data to inform a larger-scale effectiveness-implementation trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group pre-post quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| Invite Only VR Intervention Only Group | Experimental | Behavioral: Virtual reality videogame intervention for vaping preventionAll participants in the study will play the virtual reality videogame intervention, Invite Only VR. The game was developed for middle school students and focuses on e-cigarette and cannabis vaping prevention. The game also includes content and skill-development related to emotion regulation and healthy coping. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- enrolled at a participating middle school in CT
- speak English
- attending 6th, 7th, or 8th grade
- be willing to play a virtual reality videogame for 45-60 minutes/session
- ability to provide assent or parental/guardian consent
Key exclusion criteria (1 listed)
- Failure to meet inclusion criteria
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 videogame intervention for vaping preventionAlso: Invite Only VRInvite Only VR is an immersive virtual reality game designed to help adolescents build knowledge, awareness, and refusal skills around vaping through interactive, story-based social scenarios. The latest version expands its focus to include both nicotine and cannabis vaping, offering players realistic opportunities to navigate peer pressure and practice informed decision-making | Behavioural | Invite Only VR Intervention Only Group |
Primary outcome
Feasibility Assessed Using Change in Retention Rates
Time frame: From enrollment to the end of the last gameplay session, up to 1.5 hrs
Feasibility will be measured the number of participants that completed the assigned intervention.
Acceptability Assessed Via Self-reported Survey
Time frame: End of Final Gameplay Session, up to 1.5 hrs
Acceptability of the intervention is assessed via self-reported survey at the post-gameplay time point using the game experience and satisfaction questionnaire, which is a 12-item scale custom-created for this study with 4-point Likert-type responses ranging from 1 (strongly disagree) to 4 (strongly agree). Total score range 12-42. Higher scores indicate stronger agreement with the statement.
Usability of the Intervention Assessed via Self-Reported Survey
Time frame: End of Final Gameplay Session, up to 1.5 hrs
Usability of the intervention will be assessed via self-reported survey at the post-gameplay time point using the System Usability Scale (SUS), which is a 10-item scale with 5-point Likert-type responses ranging from 1 (strongly disagree) to 5 (strongly agree). Total score range 10-50. Higher scores indicate stronger agreement with the statement.
3 secondary outcomes
Change in Intentions to Use E-cigarettes from Pre- to Post-Intervention
Time frame: Baseline and immediately following the last gameplay session, up to 1.5 hrs.
Change in Nicotine and Cannabis Harm Perceptions
Time frame: Baseline and immediately following the last gameplay session up to 1.5 hrs.
Changes in Nicotine and Cannabis Vape Knowledge
Time frame: Baseline and immediately following the last gameplay session, up to 1.5 hrs.
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 17 Feb 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. This study is not recruiting at the moment.
Kimberly Hieftje, PhD principal investigator
Yale University
Deepa Camenga, MD principal investigator
Yale University
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 videogame intervention for vaping prevention in people with Cannabis and Vaping, run by Yale 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 5 inclusion and 1 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 17 Feb 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?
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?
Feasibility Assessed Using Change in Retention Rates (time frame: From enrollment to the end of the last gameplay session, up to 1.5 hrs). 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 17 Feb 2026.