An observational study in Vaping, sponsored by Yale University. Enrolling by invitation at 2 sites in United States. Open to participants aged 12 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Yale University · Observational
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Among 22 studies in Vaping by Yale University — 6 open to participants now, 6 under way, none of them phase 3. Vaping · Yale University.
Among the 22 studies in Vaping by Yale University, this one is one of 5 that started in 2025, is the only observational one, and was the 20th registered.
403 studies on the registry are indexed under Vaping; 96 are open to participants now.
Browse Vaping studies →6 of the 22 studies in Vaping by Yale University are open now, in 1 country. Recruiting first, the newest first:
Yale University · Sites in United States
Ages 21–44 · Healthy volunteers
Yale University · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 12–19 · Healthy volunteers
Yale University · Sites in United States
Ages 14+ · Healthy volunteers
By country, each count listing its studies:
Of the 64 Vaping studies recruiting now, 32 (50%) set no upper age limit and 31 (48%) stop at 75 or younger; 13 take children under 18; 40 take healthy volunteers.
This study: 12 Years to 15 Years · all sexes · healthy volunteers too.
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22 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 5 started in 2025.
This study's planned enrollment of 40 is below the median of 120 across 65 observational studies indexed under Vaping.
Median enrollment 60 across the 21 interventional studies, 40 across the 1 observational. Of the 15 that completed or were terminated, 7 (47%) have results posted.
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Yale University is the lead sponsor of 1,772 studies on the registry; 296 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
2 of the studies in Vaping by Yale University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07553585Yale UniversitySurvey to Test the Nicotine Concentration and Nicotine Flux Labels for E-cigarettes | 2026-12-15 |
| NCT07398976Yale UniversitySex Differences in E-Cigarette Perception | 2027-04-01 |
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Among the 22 studies in Vaping by Yale University, from their registry updates:
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This study will examine E-Invite Only VR, a novel school-based universal e-cigarette prevention intervention that uses virtual reality (VR) to deliver prevention and emotion regulation skills-building content to middle school students in real-world classrooms. In Phase 1, investigators will conduct focus groups with adolescents and interviews with school staff to inform the development and implementation of the intervention.
Investigators will conduct focus groups with adolescents. 4 focus groups will focus on collecting adolescents' perceptions about e-cigarettes and students' mental health needs in general, and how they perceive the link between the 2 constructs. Participants will also play E-Invite Only VR and then convene to share their thoughts and experiences. Participants will also fill out surveys including the System Usability Scale and the Gameplay Experience Questionnaire.
Staff will review and discuss the E-Invite Only VR implementation plan and respond to the Feasibility of Implementation Plan assessment during the interviews. Investigators will work with two populations: 1) Adolescents attending 8th grade in one of our partner schools, and 2) School staff employed by a partner school.
The target user for the E-Invite Only VR intervention is 8th grade students because the game is focused on prevention. Early adolescence is known to be a critical period for the risk of nicotine dependence and the transition between middle school and high school is a period when youth might be particularly likely to experiment with substances such as e-cigarettes.
Investigators will work with school staff to ensure the E-Invite Only VR intervention is feasible to implement in schools.
The targeted study population is 8th grade adolescents and school staff (teachers, wellness coordinators, school counselors, and school psychologists) in participating schools.
School staff:
English speaking
8th grade adolescents
Investigators will conduct focus groups with a sample of 8th-grade adolescents. To inform the conceptual model, investigators will ask students to describe perceptions about e-cigarettes and students' mental health needs in general, and how they perceive the link between the two constructs. Investigators will conduct interviews with 20 school staff, such as health teacher, school counselors, etc) to inform the implementation plan.
Acceptability of the the Videogame
The Gameplay experience questionnaire, consisting of 11 items ranging from strongly disagree to strongly agree, will be used to assess adolescents' perception of the acceptability of the videogame intervention.
Time frame: Immediately after the focus group and gameplay testing of the intervention, Day 1
System Usability Scale
The System Usability Scale (SUS), 10 items ranging from "strongly disagree" to "strongly agree" will be completed by adolescents and school staff to access the usability of the intervention.
Time frame: Immediately after the focus group and gameplay, Day 1
Feasibility of Implementation
Feasibility of Implementation, consisting of 5 items ranging from "Strongly disagree" to "strongly agree" will be used to assess feasibility of the intervention.
Time frame: Immediately after interviews with school staff, Day 1
Plan to share: Yes — Investigators will make focus group data and associated documentation available to users only under a data-sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will generally be available within one year of completion of the funded project period or upon acceptance of the first publication.
Access criteria: Investigators will make focus group data and associated documentation available to users only under a data-sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant, (2) a commitment to securing the data using appropriate computer technology, and (3) a commitment to destroying or returning the data after analyses are completed. Data will generally be available within one year of completion of the funded project period or upon acceptance of the first publication. Data will also be available through publications and presentations at scientific meetings. Findings will be published in scientific journals. All manuscripts that arise from this proposal will be submitted to PubMed Central.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Feb 2026, 3 months after the start.
Of 32 observational studies under Vaping, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 46. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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