NCT05447325 · University of Georgia
Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Escalation in Young Adult ENDS Users
What this study is about
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 randomly assigned controlled trial.
View original scientific description
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.
Interventions
BEHAVIORAL
Exposure to Anti-Vaping Messages (generic themes then flavor-specific themes)
Messages are in the format of public service announcement (PSA) images that contain both textual (1-2 brief sentences) and illustrative visual components. The messages are designed to educate the participants about the harms and costs associated with e-cigarette use (e.g., negative health consequences, undesirable social perceptions, etc.). Half of the messages focus specifically on the harms and costs associated with using flavored vape products, while the other half address vaping harms broadly (i.e., not specifically focus on those related to flavored vaping). Participants in this arm will receive anti-vaping messages through emails and text messages every week. Specifically, over the course of a year, during the first six months, they will receive generic/regular PSAs that address vaping harms more broadly; during the second six months, they will receive flavor-specific PSAs that address vaping harms specifically associated with the use of flavored vape products.
BEHAVIORAL
Exposure to Anti-Vaping Messages (flavor-specific themes then generic themes)
Messages are in the format of public service announcement (PSA) images that contain both textual (1-2 brief sentences) and illustrative visual components. The messages are designed to educate the participants about the harms and costs associated with e-cigarette use (e.g., negative health consequences, undesirable social perceptions, etc.). Half of the messages focus specifically on the harms and costs associated with using flavored vape products, while the other half address vaping harms broadly (i.e., not specifically focus on those related to flavored vaping). Participants in this arm will receive anti-vaping messages through emails and text messages every week. Specifically, over the course of a year, during the first six months, they will receive flavor-specific PSAs that address vaping harms specifically associated with the use of flavored vape products; during the second six months, they will receive generic/regular PSAs that address vaping harms more broadly.
BEHAVIORAL
Exposure to Anti-Vaping Messages (no message exposure)
Participants will not receive any message intervention in this arm.
Primary outcome measures
Self-report monthly smoking severity
Time frame: 12 months
The monthly number of cigarettes smoked will be assessed with the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily cigarette use for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly smoking severity measure. The greater the number, the higher the smoking severity in that month.
Self-report monthly vaping severity
Time frame: 12 months
The monthly number of vaping sessions (a vaping session refers to a minimum of about 15 puffs or vaping that lasts around 10 minutes) will be assessed with the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily vaping sessions for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly vaping severity measure. The greater the number, the higher the vaping severity in that month.
Exhaled carbon monoxide (CO) levels
Time frame: 12 months
Quarterly assessed exhaled CO levels quantified by parts per million (PPM)
Urine cotinine levels
Time frame: 12 months
Quarterly assessed urine cotinine levels (none, low, medium, high)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- used e-cigarettes or other vaping devices at least 3 days during the past 30 days
- did not smoke a cigarette, even one or two puffs, during the past 30 days
- Magnetic resonance imaging (MRI) compatible and safe
Exclusion criteria
- used e-cigarettes or other vaping devices for less than 3 days during the past 30 days
- any use of cigarettes during the past 30 days
- history of a major neurological, psychiatric, or medical disorder
- MRI contraindications
Where
- Athens, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations