NCT01031121

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

Completed Last updated 2 July 2017

What this trial tests

trial in Nicotine Dependence in 240 participants. Completed in 22 October 2010.

Timeline

8 June 2009

22 October 2010

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	240
Start date	8 June 2009
Estimated completion	22 October 2010
Sites	1 location across United States

Conditions studied

• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 64, any sex, with Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.