Nicotine DependenceNCT01031121
Breath Carbon Monoxide and Cotinine as Biomarkers to Distinguish Smokers From Nonsmokers
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Nicotine Dependence
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2009to 22 Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- For Smokers:
- males and females 18-64 years old
- smoking 1-10 cigarettes or > 10 cigarettes per day for the past 6 months
- For Nonsmokers:
- 1. males and females 18-64 years old
Who cannot join
- For Smokers:
- current interest in reducing or quitting smoking
- treatment for nicotine dependence in the past 3 months
- use of nicotine replacement products, bupropion, or varenicline in the past 3 months
- current use of tobacco products other than cigarettes
- marijuana use greater than 5 times in past 14 days or use during 24 hours before session
Show all 13Show fewer
- chronic pulmonary disease
- study investigator or subordinate staff
- For Nonsmokers:
- use of any tobacco or nicotine products in the past 3 months
- marijuana use greater than 5 times in past 14 days or use during 24 hours before session
- chronic pulmonary disease
- study investigator or subordinate staff
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Nicotine Dependence
- Keywords
- Cigarette Smoking, Biomarkers, Nicotine, Cotinine, Metabolites
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start8 Jun 2009
- Study completion22 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031121
- Sponsor's protocol ID
- 999909451
- Other IDs
- 09-DA-N451
- Status last verified
- 22 Oct 2010
- First submitted
- 11 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Benowitz NL. Biomarkers of environmental tobacco smoke exposure. Environ Health Perspect. 1999 May;107 Suppl 2(Suppl 2):349-55. doi: 10.1289/ehp.99107s2349.
PubMed 10350520Bernert JT, Harmon TL, Sosnoff CS, McGuffey JE. Use of continine immunoassay test strips for preclassifying urine samples from smokers and nonsmokers prior to analysis by LC-MS-MS. J Anal Toxicol. 2005 Nov-Dec;29(8):814-8. doi: 10.1093/jat/29.8.814.
PubMed 16374940Chatkin J, Fritscher L, de Abreu C, Cavalet-Blanco D, Chatkin G, Wagner M, Fritscher C. Exhaled carbon monoxide as a marker for evaluating smoking abstinence in a Brazilian population sample. Prim Care Respir J. 2007 Feb;16(1):36-40. doi: 10.3132/pcrj.2007.00008.
PubMed 17297525
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Carbon Monoxide and Cotinine as Biomarkers to Distinguish Smokers From Nonsmokers
- ClinicalTrials.gov ID
- NCT01031121
- Acronym / sponsor ID
- 999909451
- Conditions
- Nicotine Dependence
- Keywords
- Cigarette Smoking, Biomarkers, Nicotine, Cotinine, Metabolites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 8 Jun 2009
- Study completion
- 22 Oct 2010
- First posted
- 14 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- males and females 18-64 years old
- smoking 1-10 cigarettes or > 10 cigarettes per day for the past 6 months
- 1. males and females 18-64 years old
Key exclusion criteria (13 listed)
- current interest in reducing or quitting smoking
- treatment for nicotine dependence in the past 3 months
- use of nicotine replacement products, bupropion, or varenicline in the past 3 months
- current use of tobacco products other than cigarettes
- marijuana use greater than 5 times in past 14 days or use during 24 hours before session
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10350520Benowitz NL. Biomarkers of environmental tobacco smoke exposure. Environ Health Perspect. 1999 May;107 Suppl 2(Suppl 2):349-55. doi: 10.1289/ehp.99107s2349.
- Background: PubMed 16374940Bernert JT, Harmon TL, Sosnoff CS, McGuffey JE. Use of continine immunoassay test strips for preclassifying urine samples from smokers and nonsmokers prior to analysis by LC-MS-MS. J Anal Toxicol. 2005 Nov-Dec;29(8):814-8. doi: 10.1093/jat/29.8.814.
- Background: PubMed 17297525Chatkin J, Fritscher L, de Abreu C, Cavalet-Blanco D, Chatkin G, Wagner M, Fritscher C. Exhaled carbon monoxide as a marker for evaluating smoking abstinence in a Brazilian population sample. Prim Care Respir J. 2007 Feb;16(1):36-40. doi: 10.3132/pcrj.2007.00008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031121, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.