Tobacco Use CessationUP2UTeacherNCT05396911
Development of UP2UTeacher for High School Youth
A study testing UP2UTeacher in people with Tobacco Use Cessation and Tobacco Use, run by University of Virginia at 1 site in United States.
Trial summary
Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco prevention and cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students. Read more about this study
- Who is it for?
- Ages 14 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Tobacco Use, Electronic Cigarette Use
- What is being tested?
- UP2UTeacher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 28 Feb 2026
- 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 14 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in the selected physical education or health class selected for participation in the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
About this study
Official title: Pilot Testing an Anti-Tobacco Intervention to Reduce Tobacco and Nicotine Use Among High School Students and Determine Feasibility
Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco prevention and cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students.
This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the intervention and developing the text messages. The second phase of the study evaluates the brief intervention, UP2UTeacher, through a cluster randomized controlled trial that compares UP2UTeacher to a no treatment control. It is hypothesized that the UP2UTeacher will reduce tobacco use at the 12-month follow-up compared to the no treatment control.
Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.
- Conditions
- Tobacco Use Cessation, Tobacco Use, Electronic Cigarette Use
- Being tested
- UP2UTeacher
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UP2UTeacherBehavioural
Also called Youth Brief Tobacco Intervention
The universal prevention program was designed as a group intervention to include components of effective tobacco control programs for youth and young adults. The intervention lasts approximately 45 minutes and is delivered in a classroom setting, utilizing a Socratic teaching style and evoking participation using the principles of motivational interviewing. UP2UTeacher targets all tobacco products with the goals to enhance motivation for youth to quit tobacco or remain tobacco-free, reduce intentions to use tobacco, promote peer discussions around the impact of using tobacco, and correct cognitive misperceptions around tobacco use.
| Study group | Role | What they receive |
|---|---|---|
| UP2UTeacher | Experimental | Youth Brief Tobacco Intervention Receives: Behavioral: UP2UTeacher |
| No Treatment Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past 30-day Tobacco Use
The primary outcome measure in this study is self-reported past 30-day use of cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, pipe tobacco, nicotine pouches and dissolvables. Past 30-day use will be determined for each product by asking participants, "In the past 30 days, did you use the following products?" with response options of "Every day" or "Some days" determining tobacco use.
Measured: past 12 months
Secondary outcomes (1)
Lifetime Tobacco Use
The secondary outcome measure in this study is self-reported lifetime use of cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, pipe tobacco, nicotine pouches and dissolvables. Lifetime use will be determined for each product by a "Yes" response to the question, "In your lifetime, have you ever tried the following products, even once or twice?" at the 12-month follow-up.
Measured: past 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start4 Apr 2022
- Primary completion31 Oct 2024
- Study completion28 Feb 2026
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 Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Foundation for Healthy Youth
- Responsible party
- Principal investigator, Melissa Little, PhD, MPH, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396911
- Sponsor's protocol ID
- SBS4719
- Acronym
- UP2UTeacher
- Status last verified
- Oct 2026
- First submitted
- 20 May 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Little MA, Mallawaarachchi I, Pilehvari A, Velmurugan P, Wester AG, Wiseman KP. Do perceptions of harm and addictiveness influence adolescent's willingness to use various tobacco and nicotine products? Tob Prev Cessat. 2025 Jun 27;11. doi: 10.18332/tpc/204746. eCollection 2025.
PubMed 40584776
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing an Anti-Tobacco Intervention to Reduce Tobacco and Nicotine Use Among High School Students and Determine Feasibility
- ClinicalTrials.gov ID
- NCT05396911
- Acronym / sponsor ID
- UP2UTeacher / SBS4719
- Conditions
- Tobacco Use Cessation, Tobacco Use, Electronic Cigarette Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Virginia Foundation for Healthy Youth
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 31 May 2022 (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.
Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco prevention and cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students.
This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the intervention and developing the text messages. The second phase of the study evaluates the brief intervention, UP2UTeacher, through a cluster randomized controlled trial that compares UP2UTeacher to a no treatment control. It is hypothesized that the UP2UTeacher will reduce tobacco use at the 12-month follow-up compared to the no treatment control.
Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UP2UTeacher | Experimental | Behavioral: UP2UTeacherYouth Brief Tobacco Intervention |
| No Treatment Control | No intervention | – |
Who may qualify
- Ages
- 14 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Enrolled in the selected physical education or health class selected for participation in the study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| UP2UTeacherAlso: Youth Brief Tobacco InterventionThe universal prevention program was designed as a group intervention to include components of effective tobacco control programs for youth and young adults. The intervention lasts approximately 45 minutes and is delivered in a classroom setting, utilizing a Socratic teaching style and evoking participation using the principles of motivational interviewing. UP2UTeacher targets all tobacco products with the goals to enhance motivation for youth to quit tobacco or remain tobacco-free, reduce intentions to use tobacco, promote peer discussions around the impact of using tobacco, and correct cognitive misperceptions around tobacco use. | Behavioural | UP2UTeacher |
Primary outcome
Past 30-day Tobacco Use
Time frame: past 12 months
The primary outcome measure in this study is self-reported past 30-day use of cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, pipe tobacco, nicotine pouches and dissolvables. Past 30-day use will be determined for each product by asking participants, "In the past 30 days, did you use the following products?" with response options of "Every day" or "Some days" determining tobacco use.
1 secondary outcome
Lifetime Tobacco Use
Time frame: past 12 months
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 6 Oct 2026.
- Derived from this study: PubMed 40584776Little MA, Mallawaarachchi I, Pilehvari A, Velmurugan P, Wester AG, Wiseman KP. Do perceptions of harm and addictiveness influence adolescent's willingness to use various tobacco and nicotine products? Tob Prev Cessat. 2025 Jun 27;11. doi: 10.18332/tpc/204746. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UP2UTeacher in people with Tobacco Use Cessation and Tobacco Use, run by University of Virginia 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 1 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 6 Oct 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?
Past 30-day Tobacco Use (time frame: past 12 months). 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 NCT05396911, 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 6 Oct 2026.