About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Exposure to Anti-Vaping Messages (generic themes then flavor-specific themes)
BehavioralMessages 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.
Exposure to Anti-Vaping Messages (flavor-specific themes then generic themes)
BehavioralMessages 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.
Exposure to Anti-Vaping Messages (no message exposure)
BehavioralParticipants will not receive any message intervention in this arm.
Treatment groups
Trial outcomes
Primary outcomes
Self-report monthly smoking severity
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
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
Quarterly assessed exhaled CO levels quantified by parts per million (PPM)
Urine cotinine levels
Quarterly assessed urine cotinine levels (none, low, medium, high)
Secondary outcomes
Self-report monthly other tobacco use severity
Frequency of other tobacco use will be assessed by the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily use of other tobacco for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly other tobacco use severity measure. The greater the number, the higher the other tobacco use severity in that month.
Cigarette smoking urge
Levels of cigarette smoking will be assessed with the Brief Questionnaire of Smoking Urges (10 items;1= strongly disagree, 7= strongly agree, with higher scores indicating greater smoking urge). Example item: "I have a desire for a cigarette right now".
Electronic cigarette dependence
Levels of nicotine dependence associated with vaping will be assessed with the Penn State Electronic Cigarette Dependence Index (which consists a total of 9 questions, some multiple-choice questions, and some Yes/No questions; Higher scores indicate greater e-cigarette dependence).
Message effectiveness perceptions
The perceived message effectiveness of the anti-vaping PSAs will be evaluated using the Perceived Message Effectiveness scale, which is consisted of four items (1 = strongly disagree, 5 = strongly agree). Example items included "This message was convincing" and "Reading this message helped me feel confident about how to best deal with vaping."
Sponsors and contacts
Click on the lead sponsor to view all of their trials.