NCT07167225招募中不适用
Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use Cigarettes, E-cigarettes and Cannabis (Co-Tox Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Differences in biomarker levels across groups
研究概览
简要总结
This study evaluates the amount of nicotine, cannabis, and toxicants linked to the use of nicotine e-cigarette and/or cannabis products in the blood and urine of young adult users as well as the cannabis and nicotine use behaviors of consumers.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate differences in self-reported nicotine and cannabis use behaviors and biomarkers of exposure to toxicants and carcinogens by product use status, to generate effect sizes required to calculate sample sizes needed for a larger study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adult (18-25 years old).
- •Ability to read and write in English.
- •Participants must fall into one of the following groups (based on self-report):
- •Predominant e-cigarette consumer: defined as using nicotine-containing e-cigarettes daily for the past six months but not having used other nicotine containing products more than weekly or cannabis products for the past month.
- •Predominant cannabis consumer: defined as using cannabis at least 3x/week for the past six months in any form, including smoking, vaping, and oral use, with no more than weekly use of any nicotine or tobacco products.
- •E-cigarette-cannabis co-consumers: defined as daily use of nicotine e-cigarettes and use of cannabis at least 3x/week, including smoking, vaping, and oral use, for at least the past six months, with no use of other nicotine containing products more than weekly
- •Predominant cigarette consumers: defined as using cigarettes at least daily for the past six months, but not have used other nicotine-containing products more than weekly or cannabis products for the past month
- •Predominant cigarette-cannabis co-consumers: defined as those reporting daily cigarette use and use of cannabis at least 3x/week (including smoking or vaping) for at least the past six months, with no more than weekly use of other nicotine-containing products
- •No self-reported diagnosis of kidney disease (current, or within the past year prior to the study visit).
- •Participants must understand the voluntary nature of this study and sign a written informed consent form before proceeding with study activities.
排除标准
- •Individuals under the age of 18 or over the age of
- •Currently pregnant or breastfeeding (female participants).
- •Unwilling or unable to follow protocol requirements
结局指标
主要结局
Differences in biomarker levels across groups
时间窗: 1 study session lasting 1 hour
Will compare the mean biomarker levels between groups using a one-way ANOVA model, with Bonferroni-adjusted pairwise comparisons, as appropriate.
次要结局
- Differences in self reported nicotine and cannabis use behaviors(1 study session (1 hour))
- Differences in psychosocial characteristics by group(1 study session (1 hour))
- Study interest(Up to 1 year)
- Recall of study recruitment advertisement type(1 study session (1 hour))
- Recall of recruitment channel(1 study session (1 hour))
- Completion method chosen by participants(1 study session (1 hour))
研究者
研究点 (2)
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