Switching to Low Oxidant Content Cigarettes in Adult Smokers
研究概览
详细说明
Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between the ages of 21-65 who smoke at least 10 cigarettes a day for at least one year.
The aim of this study is to evaluate the effect of reduced oxidative/ nitrogen species (ROS/RNS) cigarettes compared to high ROS/RNS cigarettes.
Study participation lasts 8 weeks, with 5 study visits at the Hershey Medical Center. All eligible participants will be given Spectrum research cigarettes, provided free of charge, and will be asked to only smoke those cigarettes for the first four weeks of the study. Following that four-week period of time all participants will be given low ROS content cigarettes (American Spirit Dark Green or Pall Mall Red). Participants will be asked to smoke only these cigarettes for the final four weeks of the study, these cigarettes will also be provided to you free of charge.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Penn State Hershey
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 21-65
- Smoke 10 cigarettes per day or more for at least one year
- Read and write in English
- Menthol and nonmenthol smokers
- Able to understand and provide consent to study procedures
- Plan to live in the local area for the next 3 months
- Women not pregnant or nursing and taking steps to avoid pregnancy
- No quit attempt in the last one months and not planning to quit in the next 3 months (ensuring stability of smoking)
Exclusion Criteria:
- Currently pregnant or nursing
- Unstable or significant medical conditions that affect oxidative stress, such as COPD, kidney failure, heart disease, stroke, cancer, tumors, lung or respiratory disease, diabetes, liver disease, autoimmune disorder, rheumatoid arthritis, infectious disease or fibromyalgia.
- Use of non-cigarette nicotine delivery
- History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
- Current or recent history of substance or alcohol abuse
- No more than seven alcoholic drinks a week, and/ or >two drinks a day
- Use of a high dose antioxidant supplement prior to 1 month
- Currently smoking cigarettes that will be used for the study (Pall Mall Red or American Spirit Dark Green)
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Reduced ROS/RNS content products
Participants will be given and asked to smoke research cigarettes for the first 4 weeks.
For the final 4 weeks of the study they will be given and asked to smoke low ROS content cigarettes.
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Participants will be given and asked to spoke only the cigarettes provided for them.
Biosamples and surveys will be collected every 2 weeks throughout the study.
Participants will be given and asked to spoke only the cigarettes provided for them.
Biosamples and surveys will be collected every 2 weeks throughout the study.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Biomarkers of oxidative stress
大体时间:8 weeks
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The primary endpoint is to assess whether levels of oxidative stress/damage increase or decrease when a smoker switches from a high ROS/NOS cigarette product to a low ROS/NOS product.
The biomarkers that will be used to assess oxidative stress include: 8-0HdG, glutathionylated proteins, and urinary F,-isoprostanes cysteine and GSH.
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Antioxidant and nutrient levels in the blood
大体时间:8 weeks
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Secondary endpoints include measurements of nicotine exposure (urine or plasma cotinine).
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8 weeks
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合作者和调查者
合作者
调查人员
- 首席研究员:John Richie, Ph.D、Milton S. Hershey Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY00006759
- 5P50DA036107-02 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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