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临床试验/NCT01031121
NCT01031121已完成不适用

Breath Carbon Monoxide and Cotinine as Biomarkers to Distinguish Smokers From Nonsmokers

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2009年6月8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
240
试验地点
1

研究概览

简要总结

Background:

  • Self-report and biochemical verification are used to determine smoking status in treatment trials and clinical research. Each method has merits and limitations that make it appropriate for particular situations. Participants who feel social pressure to report tobacco abstinence may provide unreliable self-reporting results. Biochemical verification using breath carbon monoxide (CO) is a more reliable indicator, but several biological and environmental factors (including exposure to secondhand smoke) can affect the sensitivity and specificity of breath CO measurement.
  • An ideal biomarker of smoking status is cotinine, the major metabolite of nicotine. Cotinine levels found in blood, urine, and saliva can be used to distinguish between smokers and nonsmokers, as well as between light and heavy smokers. Researchers are interested in using cotinine assessments to develop suitable breath CO cutoff levels to categorize different types of smokers and nonsmokers for use in future research.

Objectives:

  • To determine a breath carbon monoxide (CO) cutoff level that optimally discriminates between heavy and light smokers and nonsmokers who are and who are not exposed to environmental tobacco smoke.

Eligibility:

  • Individuals between 18 and 64 years of age who fall into one of the following groups:
  • current smokers reporting more than 10 cigarettes per day for at least 6 months
  • current smokers reporting 10 or fewer cigarettes per day for at least 6 months
  • nonsmokers reporting regular environmental exposure to tobacco smoke
  • nonsmokers reporting limited or no exposure to tobacco smoke

Design:

  • The study will involve a single outpatient session.
  • Participants will provide breath CO, urine, and saliva samples, and will complete several smoking-related questionnaires on smoking history, current craving levels, and perceived level of nicotine dependence.

详细描述

Objective:

To determine a breath carbon monoxide (CO) cutoff level that optimally discriminates between heavy and light smokers and nonsmokers who are and who are not exposed to environmental tobacco smoke. Breath CO will be compared against cotinine concentration, which is the gold standard in verifying smoking status.

Study population:

The study will include four groups: 1) 60 smokers reporting > 10 cigarettes per day, 2) 60 smokers reporting less than or equal to 10 cigarettes per day, 3) 60 nonsmokers reporting regular environmental exposure to tobacco smoke, and 4) 60 nonsmokers reporting limited or no environmental exposure to tobacco smoke (total of 120 smokers and 120 nonsmokers).

Design:

研究设计

研究类型
Observational
时间视角
Other

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (1)

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