Effects of Electronic Nicotine Delivery System Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability Among African American Menthol Smokers (RVA Flavors)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in Average Daily Cigarette Use
研究概览
简要总结
This study aims to better understand how the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers.
详细描述
Black/African American (AA) menthol smokers are disproportionately harmed by tobacco products and could experience significant health benefits from increased availability of well-regulated electronic nicotine delivery systems (ENDS). The current study will evaluate whether ENDS flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers by performing a 3-arm, 6-week clinical trial of ENDS provision with follow-up to 30 days. Results of this work will help FDA make predictions about the impact of moving from the current regulatory market were menthol/tobacco flavored ENDS cartridges are available, to one where only tobacco or unflavored cartridges are available, in order to maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21+ years of age
- •identify as Black/African American (single or multi-race)
- •have used ≥5 cigarettes per day for ≥1 year
- •biochemically confirmed cigarette smoking status
- •regular cigarette brand is flavored to taste like menthol or mint
- •ENDS use in the past 3 months
- •report no intent to quit smoking in the next 6 months
- •previous quit attempt using evidence-based method
- •have a working mobile phone with a texting/data plan
- •are willing receive phone calls/text messages and complete internet-based/online surveys related to the study.
- •read and write in English
排除标准
- •are unwilling to use ENDS as part of the trial
- •unstable or significant medical condition in the past 12 months
- •report any other illegal drug use in past 30 days
- •report intent to become pregnant or current pregnancy/breastfeeding
- •report any other condition that may affect participant safety or not allow them to fully participate in the study
研究组 & 干预措施
Menthol+Tobacco
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
干预措施: Tobacco product administration and assessment (Other)
Tobacco
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
干预措施: Tobacco product administration and assessment (Other)
Unflavored
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
干预措施: Tobacco product administration and assessment (Other)
结局指标
主要结局
Change in Average Daily Cigarette Use
时间窗: Week 1 vs. Week 6
Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Change in Carbon Monoxide Exposure
时间窗: Week 1 vs. Week 6
A biomarker of combusted cigarette use collected from exhaled breath
Willingness to Substitute from Cigarettes to ENDS
时间窗: Week 6
Measure of substitution for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced.
Average Daily Cigarette Use
时间窗: Randomization and Week 6
Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Carbon Monoxide Exposure
时间窗: Randomization and Week 6
A biomarker of combusted cigarette use collected from exhaled breath.
Willingness to Substitute From Cigarettes to ENDS
时间窗: Week 6
CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios involving their own brand cigarettes and condition-specific ENDS. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a their conditions-specific ENDS they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each ENDS puff cost $0.10. The outcome of the task is the willingness to pay in USD for each ENDS puff.
次要结局
- Change in Proplyne Glycol Exposure(Week 1 vs. Week 6)
- Willingness to Pay for ENDS(Week 6)
- Change in NNAL Exposure(Week 1 vs. Week 6)
- Change in Average Daily ENDS Use(Week 1 vs. Week 6)