Clinical trial NCT05829863: A Neuroimaging Approach to Advance Mechanistic Understanding of Tobacco Use Escalation Risk Among Young Adult African American Vapers
Official title: A Neuroimaging Approach to Advance Mechanistic Understanding of Tobacco Use Escalation Risk Among Young Adult African American Vapers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Message Exposure
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: During the baseline fMRI scan, participants will be exposed to anti-vaping public service announcements (PSAs) utilizing cognitive, emotional and social appeals to address the negative consequences of vaping.
Primary purpose: TREATMENT

Brief summary: 60 young adult African American vapers who are not current smokers will participate in a baseline functional magnetic resonance imaging (fMRI) experiment, with 4 weekly follow-up surveys to gauge their tobacco use behaviors following the baseline scan. 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).

Detailed description: 60 African American young adult current vapers will be recruited from multiple sources including the University of Georgia (UGA) student research pools from the Communication and Psychology Departments, flyers, 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 3-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), and hair and fingernail samples will be collected to gauge their chronic stress levels, 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, participants will be exposed to (1) traditional cue reactivity stimuli used in tobacco research, including vaping, smoking, and office product images and scenarios, (2) e-cigarette packaging stimuli featuring menthol and tobacco flavors, and (3) static, visual, and textual anti-vaping public service announcements (PSAs). Immediately following each condition, participants are asked to assess their levels of craving for vaping and smoking. Their evaluations of the stimuli viewed in the scanner will also be conducted in post-scan survey after the 1-hour fMRI scan is completed.

In the next 4 weeks following the baseline scan, participants will receive a weekly survey link in their emails and text messages. In the survey, they will be asked to recall their tobacco and other substance use behavior during the past 7 days.

Eligibility criteria: Inclusion Criteria:

* 18-29 years old
* used e-cigarettes or other vaping devices at least once during the past 30 days
* did not smoke or use cigarettes during the past 30 days
* self-identify as African American
* magnetic resonance imaging (MRI) compatible and safe

Exclusion Criteria:

* younger than 18 years old, or older than 29 years old
* did not use e-cigarettes or other vaping devices during the past 30 days
* smoked or use cigarettes at least once during the past 30 days
* history of a major neurological, psychiatric, or medical disorder
* MRI contraindications

Primary outcomes:
measure: Self-report smoking severity in the following month
timeFrame: 1 month
measure: Self-report vaping severity in the following month
timeFrame: 1 month
measure: Self-report vaping intention
timeFrame: 1 week
Secondary outcomes:
measure: Message effectiveness perceptions
timeFrame: 1 week
measure: Self-report other tobacco use severity in the following month
timeFrame: 1 month
measure: Self-report other substance use severity in the following month
timeFrame: 1 month
Other outcomes:
Locations:
city: Athens
country: United States
facility: UGA Bio-imaging Research Center
state: Georgia
Study officials:
References: