Clinical trial NCT05447325: Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Use Escalation Among Young Adult Electronic Nicotine Delivery Systems Users
Official title: Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Use Escalation Among Young Adult Electronic Nicotine Delivery Systems Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Message Exposure (sequence: Regular Then Flavor)
Message Exposure (sequence: Flavor Then Regular)
No Message Exposure (control Condition)
Keywords: health message intervention
randomized controlled trial
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In the PSA exposure conditions, half of the participants will receive regular PSA exposure during the first 6 months and then switch to receiving flavor PSA exposure during the second 6 months; the other half will first receive flavor PSAs, and then the regular PSAs.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 180 young adult current vapers will be recruited from multiple sources including the University of Georgia (UGA) student research pools from the Communication, Psychology, and Sociology Departments, posters, yard signs, local community liaisons, and via Craigslist and social media ads. The screening will begin with a brief online survey. The link to the survey will be included in the research pool websites, flyers, and social media ads. Those eligible after the screening will be invited to interview via Zoom for a more detailed assessment of eligibility. Eligible participants will be sent a pre-scan survey (about 0.5 hours) 24 hours prior to the in-person lab visit. They will then be invited to a 1.5-hour visit to UGA's Bioimaging Research Center (BIRC) and instructed to vape, or not, as usual that day. Upon arrival, participants' eligibility will be confirmed, and written informed consent will be obtained. Breath and urine samples will be collected to biochemically confirm the level of nicotine exposure (i.e., tobacco use severity), followed by the remaining pre-scan measures. Participants will then be trained to perform the fMRI tasks. During fMRI, they will wear earplugs and MR-compatible vision correction, if needed, and lie on the scanner table. Stimuli will be back-projected, and responses collected using a four-button response box configured to allow on-screen Likert scale ratings of 1-7, both via Eprime 3.0 software. MRI will last approximately 60min, followed by post-scan measures (about 0.5 hours).

After the baseline fMRI scan, investigators will deliver static, visual, and textual anti-vaping public service announcements (PSAs) and assess participants' evaluations of the PSAs weekly through brief online surveys via e-mails and text messages. In the two PSA conditions, every week participants will receive an email and a text message through which a static visual anti-vaping PSA will be displayed to them before a query to evaluate the perceived effectiveness of the PSAs, followed by questions about their tobacco use status during the past week. Half of the PSA condition participants (n=60) will be exposed to regular PSAs that focus generally on the negative consequences of vaping, and the other half (n=60) will be exposed to flavor PSAs, which focus specifically on the harms and negative consequences associated with vaping flavored e-cigarettes. Flavor PSAs will be both drawn from existing regular PSAs and created by adding a flavor theme on regular PSAs because existing flavor PSAs are still rare. PSA condition participants will switch types of PSA exposure after 6 months. Each week a different PSA will be displayed to the participants. Therefore, half of the PSA condition participants will be exposed to 24 regular PSAs during the first 6 months, and then to 24 flavor PSAs during the second 6 months. For the other half of the PSA condition participants, they will also be displayed the same 48 PSAs, but in the reverse sequence, i.e., 24 flavor PSAs first, then 24 regular PSAs next. Participants in the control condition (n=60) will directly answer the survey questions about their tobacco use status during the past week without PSA exposure and evaluation.

At 3-, 6-, 9- and 12-months participants will complete a 15-min visit that includes a CO confirmation for smoking, a urinary cotinine test for nicotine use, and other in-person follow-up measures.

Eligibility criteria: 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

Primary outcomes:
measure: Self-report monthly smoking severity
timeFrame: 12 months
measure: Self-report monthly vaping severity
timeFrame: 12 months
measure: Exhaled carbon monoxide (CO) levels
timeFrame: 12 months
measure: Urine cotinine levels
timeFrame: 12 months
Secondary outcomes:
measure: Self-report monthly other tobacco use severity
timeFrame: 12 months
measure: Cigarette smoking urge
timeFrame: 12 months
measure: Electronic cigarette dependence
timeFrame: 12 months
measure: Message effectiveness perceptions
timeFrame: 12 months
measure: Vaping intention
timeFrame: 12 months
measure: Smoking intention
timeFrame: 12 months
measure: Self-report monthly other substance use severity
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: UGA Bio-imaging Research Center
state: Georgia
Study officials:
References: