Clinical Trial

Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Escalation in Young Adult ENDS Users

Recruiting
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Record status
This record was last updated April 3, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
180 young adult vapers who are not current smokers will participate in a baseline functional magnetic resonance imaging (fMRI) experiment, prospectively linked to a 1-year randomized controlled trial. Baseline fMRI tasks will probe critical neurocognitive markers with high potential to account for individual differences in nicotine use prognosis and responsiveness to anti-vaping public service announcements (PSAs). Participants will be assigned randomly to a survey-only control condition, or one of two intervention orders, Regular PSA then Flavor PSA, and Flavor PSA then Regular PSA (n=60 each) in a 1-year counterbalanced crossover design. Every week intervention groups will receive anti-vaping PSAs either do not specifically address harms associated with vaping flavors (regular PSAs) or PSAs with a theme focusing on the harms of flavored vape products (flavor PSAs). Participants of the intervention groups will switch PSA exposure condition after 6 months. Their evaluations of the PSAs will be assessed with brief weekly online surveys. The links to the weekly online surveys will be sent via e-mail and text which allow them to access the surveys using any device with an internet browser. During the survey, the PSA of that week will first be displayed to PSA groups (n=120), followed by a query to provide message evaluation. Afterward, the survey questions will also assess their e-cigarette, cigarette, other tobacco use, and nicotine dependence, during the past week. The control group (n=60) will complete the surveys without viewing PSAs. In-person assessments at 3, 6, 9, and 12 months will biochemically confirm nicotine exposure.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-07-01; most recent amendment 2026-03-30.
Status change: Not Yet Recruiting → Recruiting 2023-04-13
Trial Details
NCT Number NCT05447325
Lead Sponsor University of Georgia
Conditions Message Exposure (Sequence: Regular Then Flavor), Message Exposure (Sequence: Flavor Then Regular), No Message Exposure (Control Condition)
Enrollment 180 participants
Start Date 2022-07-15
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-03