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临床试验/NCT05829863
NCT05829863已完成不适用

A Neuroimaging Approach to Advance Mechanistic Understanding of Tobacco Use Escalation Risk Among Young Adult African American Vapers

University of Georgia2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Self-report smoking severity in the following month

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The participants will be prevented from knowing the different message appeals to which they are exposed.

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Self-report smoking severity in the following month

时间窗: 1 month

The weekly 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 vaping severity in the following month

时间窗: 1 month

The weekly 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.

Self-report vaping intention

时间窗: 1 week

Right after the fMRI scan and the anti-vaping PSA exposure, participants will be asked to indciate their intention to use e-cigarette in the next week.

次要结局

  • Message effectiveness perceptions(1 week)
  • Self-report other tobacco use severity in the following month(1 month)
  • Self-report other substance use severity in the following month(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiaying Liu

Associate Professor

University of Georgia

研究点 (2)

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