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NCT05396911 · ClinicalTrials.gov registry record · NA
Development of UP2UTobacco for High School Youth
A NA study of Tobacco Use and Tobacco Use Cessation, sponsored by University of Virginia.
- Active
- Registry status
- NA
- Development phase
- 432
- Enrollment target
- 1
- Study location
NCT05396911: Active NA study of Tobacco Use and Tobacco Use Cessation, sponsored by University of Virginia.
NCT05396911 is a NA study of Tobacco Use and Tobacco Use Cessation that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 432 participants, above the 373-participant average among 76 other Tobacco Use trials with a reported enrollment target (16% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05396911, a NA study of Tobacco Use and Tobacco Use Cessation, is active but no longer recruiting, sponsored by University of Virginia.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 432 participants
- Enrollment target
- 1
- Study location
Study Summary
Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco 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, UP2UTobacco, through a cluster randomized controlled trial that compares UP2UTobacco to a no treatment control. It is hypothesized that the UP2UTobacco will produce greater abstinence at the 6-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.
Primary Outcome
The primary outcome measure in this study is self-reported past 30-day abstinence from cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, and pipe tobacco. Past 30-day abstinence will be determined for each product by a "No" response to the question, "In the past 30 days, have you used a \<insert tobacco product name\>, even one or two times or puffs?"
Conditions Studied
Interventions
- BEHAVIORAL UP2UTobacco
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2026-02-28 |
| Phase | NA |
What the registry record for NCT05396911 still lists
NCT05396911 is an interventional study that assigns participants to a tested intervention. The registered 432 participants enrollment target is mid-sized for trials with a published cap, above the 373-participant average among 76 other Tobacco Use trials with a reported enrollment target (16% higher).
The record links to 3 conditions, with Tobacco Use appearing as the primary indexed condition, and to 1 intervention - of which UP2UTobacco is the first listed.
NCT05396911 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05396911 about?
NCT05396911 is a clinical study titled "Development of UP2UTobacco for High School Youth". Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco 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...
What is the current status of trial NCT05396911?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 432 participants. The study started on 2022-04-04. Estimated completion is 2026-02-28.
What conditions does trial NCT05396911 study?
This clinical trial studies the following conditions: Tobacco Use, Tobacco Use Cessation, Electronic Cigarette Use.
What interventions are being tested in trial NCT05396911?
The interventions under investigation include: UP2UTobacco (BEHAVIORAL).
Who is sponsoring clinical trial NCT05396911?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05396911 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05396911's enrollment target sits among peer trials
432 15th of 76 higher than 62 of 76 other Tobacco Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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