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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01031121
First received: December 11, 2009
Last updated: October 26, 2010
Last verified: October 2010
  Purpose

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.

Condition
Nicotine Dependence

Study Type: Observational
Official Title: Breath Carbon Monoxide and Cotinine as Biomarkers to Distinguish Smokers From Nonsmokers

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 240
Study Start Date: June 2009
Estimated Study Completion Date: October 2010
Detailed Description:

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:

Parallel groups design.

Outcome Measures:

1) breath CO; 2) semiquantitative salivary cotinine; 3) quantitative salivary nicotine, cotinine, and 3-hydroxycotinine; 4) semiquantitative urinary cotinine; 5) quantitative urinary nicotine, cotinine, norcotinine, and 3-hydroxycotinine; and 6) self-reported smoking variables.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

For Smokers:

  1. males and females 18-64 years old
  2. smoking 1-10 cigarettes or > 10 cigarettes per day for the past 6 months

For Nonsmokers:

1. males and females 18-64 years old

EXCLUSION CRITERIA:

For Smokers:

  1. current interest in reducing or quitting smoking
  2. treatment for nicotine dependence in the past 3 months
  3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
  4. current use of tobacco products other than cigarettes
  5. marijuana use greater than 5 times in past 14 days or use during 24 hours before session
  6. chronic pulmonary disease
  7. study investigator or subordinate staff

For Nonsmokers:

  1. use of any tobacco or nicotine products in the past 3 months
  2. marijuana use greater than 5 times in past 14 days or use during 24 hours before session
  3. chronic pulmonary disease
  4. study investigator or subordinate staff
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031121

Locations
United States, Maryland
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01031121     History of Changes
Other Study ID Numbers: 999909451, 09-DA-N451
Study First Received: December 11, 2009
Last Updated: October 26, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cigarette Smoking
Biomarkers
Nicotine
Cotinine
Metabolites

Additional relevant MeSH terms:
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014