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NCT01031121 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by National Institute on Drug Abuse (NIDA).

Completed
Registry status
240
Enrollment target

NCT01031121 is a clinical trial that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 240 participants.

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The verdict

NCT01031121 has completed, sponsored by National Institute on Drug Abuse (NIDA).

COMPLETED
Registry status
240 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2009-06-08
Est. Completion 2010-10-22

What the Registry Record Tells You About NCT01031121

The ClinicalTrials.gov registry entry for NCT01031121 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01031121 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01031121 about?

NCT01031121 is a clinical study titled "Breath Carbon Monoxide and Cotinine as Biomarkers to Distinguish Smokers From Nonsmokers". 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 pr...

What is the current status of trial NCT01031121?

This trial is currently completed. The enrollment target is 240 participants. The study started on 2009-06-08. Estimated completion is 2010-10-22.

Who is sponsoring clinical trial NCT01031121?

This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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