Young Adults and Low Nicotine Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Daily cigarette consumption
研究概览
简要总结
The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.
详细描述
Investigators will recruit 100 young adult cigarette smokers to a 40-day, laboratory-based protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day baseline period, then receive your own brand free-of-charge for an additional 5-day period, and then will receive free, investigational low nicotine cigarettes for the remaining study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in three varieties; each variety will be used for a 10-day period, in counterbalanced order. Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e., carbon monoxide [CO]). You will complete in-person visits at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) every 5 days, for a total of nine in-person visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be informed that they will be supplied cigarettes with low nicotine content but will be blinded to exact nicotine content and unaware that within-subject, all packages will contain the same type of low nicotine cigarette
入排标准
- 年龄范围
- 21 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study participants will be 100 male and female young adult smokers who:
- •Are aged 18-25
- •Report smoking ≥ 100 lifetime cigarettes
- •Report smoking at least 1 non-menthol, filtered cigarette per day
排除标准
- •We will exclude those who:
- •Plan to quit smoking in the next month
- •Smoke menthol cigarettes > 80% of the time
- •Report consuming ≥ 25 alcohol-containing drinks per week
- •Report a history or current psychiatric diagnosis or severe medical condition,
- •Are color-blind or have another visual impairment (e.g., partial blindness, uncorrected cataract)
- •Are pregnant and/or lactating
- •Additional, general reasons for exclusion include:
- •Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study.
- •Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician.
- •Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
结局指标
主要结局
Daily cigarette consumption
时间窗: Days 0 through 40
Daily cigarette consumption will be assessed primarily by participant self-report and secondarily through collection of spent filters for all cigarettes smoked during the 35-day study period, and will be averaged across baseline and pack color periods.
次要结局
- Total puff volume(Days 0, 5, 10, 15, 20, 25, 30, 35, and 40)
- Risk perceptions(Days 10, 20, 30, and 40)
- Harm exposure(Days 0, 5, 10, 15, 20, 25, 30, 35, and 40)
研究者
Melissa Mercincavage
Research Assistant Professor
Abramson Cancer Center at Penn Medicine