NCT05396911: UP2UTobacco

Development of UP2UTobacco for High School Youth

Active, enrolled NA Last updated 30 October 2025

What this trial tests

NA trial testing UP2UTobacco in Tobacco Use Cessation in 432 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 April 2022

Primary endpoint
31 May 2025

28 February 2026

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	432
Start date	4 April 2022
Primary completion	31 May 2025
Estimated completion	28 February 2026
Sites	1 location across United States

Drugs / interventions tested

• UP2UTobacco

Conditions studied

• Tobacco Use Cessation — all drugs for Tobacco Use Cessation →
• Tobacco Use — all drugs for Tobacco Use →
• Electronic Cigarette Use — all drugs for Electronic Cigarette Use →

Sponsor

University of Virginia

Who can join

Adults 14 to 15, any sex, with Tobacco Use Cessation or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Do perceptions of harm and addictiveness influence adolescent's willingness to use various tobacco and nicotine products?
   Little MA, Mallawaarachchi I, Pilehvari A, Velmurugan P, et al · · 2025 · PMID 40584776 · DOI 10.18332/tpc/204746