Cigarette SmokingNCT01923402
Development of Biomarkers of Effect From Chronic Tobacco Usage
An observational study of Cigarette Smoking, run by R.J. Reynolds Tobacco Company at 1 site in United States.
Trial summary
This study was conducted to develop biomarkers of tobacco effect that would indicate potential harm related to tobacco consumption. To gain a better understanding of chronic effects of tobacco consumption, this cross-sectional clinical study enrolled generally healthy, adult male consumers of cigarettes (SMK), moist… Read more about this study
- Who is it for?
- Ages 35 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2011
- 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 35 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study target population included smokers (SMK), moist snuff consumers (MSC), and non-tobacco consumers (NTC), in generally good health, as determined by the Investigator. Exclusive tobacco smokers: n=40 Moist Snuff consumers: n=40 Non-tobacco consumers: n=40
Who may be able to join
- Males between 35 and 60 years of age, inclusive;
- Met cohort-specific requirements as follows:
- Smokers: Must have been exclusive full flavor (FF) (>13 mg FTC [Federal Trade Commission] "tar") or full flavor low "tar" (FFLT) (6.0 to 10.3 mg FTC "tar") smokers who self-reported smoking at least 10 cigarettes daily for at least the past three years prior to screening and whose expired carbon monoxide (ECO) is 10 to 100 parts per million (ppm) at screening and study check-in. Note: Subjects with an ECO of 2 to 9 ppm may have been included upon joint review by the Sponsor and the Investigator.
- Moist Snuff Consumers: Must have been exclusive moist snuff consumers of any brand (Copenhagen, Skoal, Grizzly, Kodiak, Timber Wolf, Longhorn, Red Man, etc.), any style (snuff cut, long cut, mid cut, fine cut, or pouch) and any flavor (natural, straight, mint, wintergreen, etc.) who reported using at least two can per week for at least the past three years prior to screening and whose ECO is 0 5 ppm at screening and study check-in. Note: Subjects with an ECO of 6 to 10 ppm may have been included upon joint review by the Sponsor and the Investigator.
- Non-Tobacco Consumers: Must have been non-consumers of any tobacco or nicotine-containing products for at least five years prior to study screening and whose ECO is 0 to 5 ppm at screening and study check-in. Note: Subjects with an ECO of 6 to 10 ppm may have been included upon joint review by the Sponsor and the Investigator.
- Subjects who are tobacco smokers: who did NOT intend to quit smoking nor intended to quit using moist snuff. "Intent to quit" was defined as planning a quit attempt within a month of screening.
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- All subjects must have met the American Red Cross Blood Donation Eligibility Guidelines (64) (inclusive of, but not limited to, age, blood pressure, bleeding conditions, recent donation, and weight) and have been generally healthy and felt well with no restrictions or limitations on activities.
- Weighed at least 110 pounds.
- Had a hemoglobin >/= 12.5 g/dL and a hematocrit >/= 38%.
- Tested negative for drugs of abuse by urine drug screen at screening and at study check-in, unless subject was able to present proof of a corresponding prescription concomitant medication.
- Performed a negative breath alcohol test at screening and study check-in.
- Had a negative urine cotinine test at screening and study check-in for non-tobacco consumers.
- Had a positive urine cotinine test at screening and study check-in for tobacco consumers.
- Subjects must, in the opinion of the Investigator, had been free of clinically significant health problems, including oral health.
- Not taking daily medication for a chronic medical condition deemed clinically significant by the Investigator.
- Not regularly taking creatine supplements.
- Not have used aspirin (or related drugs, other than aspirin prophylaxis up to 81 mg/day) in the seven days prior to study check-in.
- Tested negative for Hepatitis B Surface Antigen (HBsAg), negative for Hepatitis C Antibody (HCAb), and had a negative Human Immunodeficiency Virus (HIV) screen.
- At least 60 days had passed since the subject's last whole blood (standard) donation.
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
- Able to read and comprehend questionnaires in English.
Who cannot join
- Subjects who met any of the following criteria will be excluded from the study:
- Met cohort specific exclusions as follows:
- Smokers: For three years prior to the study through Day -1, the use of any tobacco- or nicotine containing product or device other than FF or FFLT tobacco-burning cigarettes, including tobacco-heating cigarettes, e cigarettes, beedis, chewing tobacco, dry snuff, moist snuff, snus, or any nicotine replacement therapy (NRT) (e.g., patch, gum, lozenge, inhaler, spray, etc.). NOTE: Subjects who have smoked < 6 cigars in the past 12 months prior to screening would NOT have been excluded. Subjects who received short-term administration of a NRT as a temporary bridging treatment would NOT have been excluded.
- Moist Snuff Consumers: For three years prior to the study through Day -1, the use of any other tobacco- or nicotine-containing product or device other than moist snuff, including tobacco-burning cigarettes, tobacco-heating cigarettes, e-cigarettes, beedis, cigars, pipes, chewing tobacco, snus, dry snuff, or any NRT (e.g., patch, gum, lozenge, inhaler, spray, etc.). NOTE: Subjects who received short-term administration of a NRT as a temporary bridging treatment would NOT have been excluded.
- Non Tobacco Consumers: For five years prior to the study through Day -1, the use of any kind of tobacco products or the use of any non-tobacco nicotine-containing products (NRTs) or devices (e.g., e-cigarettes).
- Subjects who were tobacco consumers: expressed an interest in quitting smoking or using moist snuff (defined as planning a quit attempt within a month of screening).
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- Subjects who were MSC users or non tobacco consumers: an ECO > 5 ppm at screening or study check-in (ECO of 6 to 10 ppm may not have been excluded based on joint review by the Sponsor and Investigator).
- Subjects who were smokers: an ECO < 10 ppm at screening or study check-in (ECO of 2 to 9 ppm may not have been excluded based on joint review by the Sponsor and Investigator).
- Any chronic illness that, in the opinion of the Investigator, is unstable.
- A temperature above 99.5° F.
- Poor peripheral venous access.
- Clinically uncontrolled hypertension (>/= 180 mmHg systolic or >/= 100 mmHg diastolic blood pressure).
- Diabetes mellitus (either insulin-dependent or non-insulin dependent).
- Blood sugar levels > 130 mg/dL after the minimum 8 hour fast requested at screening.
- Peak flow ≤ 70% of predicted average peak expiratory flow (PEF) for age and height.
- Clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders.
- History or presence of an abnormal electrocardiogram (ECG), which, in the Investigator's opinion, is clinically significant.
- History of alcohol abuse or illicit drug use within one year prior to study entry. NOTE: Subjects who self-reported drinking less than or equal to 14 servings of alcoholic beverages per week (1 serving = 12 ounces of beer, 6 ounces of wine, or 1 ounce of liquor) were NOT excluded.
- Presence of an acute infection, with or without antibiotic treatment.
- Any history of abnormal bleeding or clotting disorder, or an individual taking any anticoagulants.
- Any history of clotting disorder from Factor V who is taking anticoagulants.
- Cancer that has been treated successfully, but less than 5 years since completion of treatment, other than skin cancer (exclusionary of melanoma).
- Squamous or basal cell cancers of the skin that had NOT been completely removed.
- History of leukemia or lymphoma, including Hodgkin's disease and other cancers of the blood.
- Known tuberculosis.
- Sickle cell disease.
- Acquired Immune Deficiency Syndrome (AIDS) or a positive HIV antibody test.
- History of illegal intravenous (IV) drug use.
- Required use of concomitant medications that were excluded from the study.
- Less than 12 months since a blood transfusion from another person in the United States (unless his own "autologous" blood), or exposure to someone else's blood.
- Less than 6 months since diagnosis and treatment of a significant heart murmur.
- Less than 12 months since treatment for syphilis or gonorrhea was completed.
- Less than 60 days since participation in an investigational study in which receipt of an investigation drug or product occurred.
- Evidence of visible oral cancer, as found in an oral health examination at the screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
High Point Clinical Trials Center (formerly Mendenhall Clinical Research Center)
High Point, North Carolina, 27265
About this study
Official title: Development of Biomarkers of Effect From Chronic Tobacco Usage: A Clinical Study Examining Metabolic Profiling, Inflammation, and Oxidative Stress
This study was conducted to develop biomarkers of tobacco effect that would indicate potential harm related to tobacco consumption. To gain a better understanding of chronic effects of tobacco consumption, this cross-sectional clinical study enrolled generally healthy, adult male consumers of cigarettes (SMK), moist snuff (MSC), and no tobacco products (NTC).
Read the detailed description
This single site, three-group (healthy, adult male smokers (SMK), moist snuff consumers (MSC), and non-tobacco consumers (NTC), single-blind, cross-sectional study, included one overnight confinement of study subjects for Test Visit (Visit #3). No lifestyle changes were required, inclusive of tobacco habits. In addition to the Screening Visit (Visit #1), two other visits (Acceptance Visit [Visit #2] and a Test Visit [Visit #3]) were conducted at the clinical study site.
- Conditions
- Cigarette Smoking
- Keywords
- Biomarkers, Metabolic Profiling, Metabolomics, Tobacco, Smokeless Tobacco, Moist Snuff
- Medical subject headings
- Cigarette Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exclusive cigarette smokers | Not described | |
| Exclusive moist snuff consumers | Not described | |
| Non-tobacco consumers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Tobacco Exposure Biomarkers: Nicotine (NIC) and nine metabolites, Tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, mercapturic acid metabolites, and thiocyanate.
Tobacco-specific and tobacco-related biomarkers of exposure were evaluated.
Measured: Evening of Day -1, 24-hour urine collected within a 24 hour window prior to check-in
Urinary Tobacco Exposure Biomarkers: Trace metals
Tobacco-related biomarkers of exposure were evaluated.
Measured: Morning of Day 1 (fasting) from the first morning void collection
Buccal Cell Biomarkers
The analyses from buccal cell biomarkers may include assessment of epigenetic changes.
Measured: Evening of Day -1, collected ~2 hours after 8:00pm check-in and start of 24 hour fast
Blood Biomarkers of Tobacco Exposure
The biomarkers of tobacco exposure included Carboxyhemoglobin, Nicotine, Cotinine, and Thiocyanate.
Measured: Morning of Day 1 (fasting) after first morning void was obtained
Blood Biomarkers of Tobacco Effect
The biomarkers of tobacco effect included Nitric Oxide Pathway, Coagulation Factors, Oxidative Stress, Inflammation Mediators, Lipids and Lipoproteins, and Hematology.
Measured: Morning of Day 1 (fasting) after first morning void was obtained
Saliva Biomarkers
The analyses from saliva biomarkers may include assessment of epigenetic changes, cytokine profiles, and other measures to assess the effects of tobacco usage.
Measured: Morning of Day 1 (fasting), ~30 minutes after completion of blood collection and prior to buccal cell collection
Buccal Cell Biomarkers
The analyses from buccal cell biomarkers may include assessment of epigenetic changes.
Measured: Morning of Day 1 (fasting), ~30 minutes after completion of blood collection and following saliva collection
Urinary Tobacco Exposure Biomarkers: Nicotine (NIC) and nine metabolites.
Tobacco-specific biomarkers of exposure were evaluated.
Measured: Day 1 (fasting), Spot-urine collected ~2 hours after collection of first morning void and immediately following saliva/buccal collection
Secondary outcomes (1)
Health status scores from self-administered questionnaires on health, nicotine dependence, diet history, tobacco product usage, and perceived stress.
Comparison of the self-reported health status measures between the three cohorts.
Measured: All questionnaires administered once on Evening of Day -1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
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 Cigarette SmokingStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- R.J. Reynolds Tobacco Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melanie Fein, MD, Principal investigator, Mendenhall Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923402
- Sponsor's protocol ID
- RJRT-CSD0906
- Status last verified
- Feb 2016
- First submitted
- 7 Aug 2013
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Prasad GL, Jones BA, Chen P, Gregg EO. A cross-sectional study of biomarkers of exposure and effect in smokers and moist snuff consumers. Clin Chem Lab Med. 2016 Apr;54(4):633-42. doi: 10.1515/cclm-2015-0594.
PubMed 26495926Jessen WJ, Borgerding MF, Prasad GL. Global methylation profiles in buccal cells of long-term smokers and moist snuff consumers. Biomarkers. 2018 Nov;23(7):625-639. doi: 10.1080/1354750X.2018.1466367. Epub 2018 Jul 3.
PubMed 29771158Arimilli S, Madahian B, Chen P, Marano K, Prasad GL. Gene expression profiles associated with cigarette smoking and moist snuff consumption. BMC Genomics. 2017 Feb 14;18(1):156. doi: 10.1186/s12864-017-3565-1.
PubMed 28193179
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Biomarkers of Effect From Chronic Tobacco Usage: A Clinical Study Examining Metabolic Profiling, Inflammation, and Oxidative Stress
- ClinicalTrials.gov ID
- NCT01923402
- Acronym / sponsor ID
- RJRT-CSD0906
- Conditions
- Cigarette Smoking
- Keywords
- Biomarkers, Metabolic Profiling, Metabolomics, Tobacco, Smokeless Tobacco, Moist Snuff
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- R.J. Reynolds Tobacco CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Aug 2013 (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.
This study was conducted to develop biomarkers of tobacco effect that would indicate potential harm related to tobacco consumption. To gain a better understanding of chronic effects of tobacco consumption, this cross-sectional clinical study enrolled generally healthy, adult male consumers of cigarettes (SMK), moist snuff (MSC), and no tobacco products (NTC).
Detailed description
This single site, three-group (healthy, adult male smokers (SMK), moist snuff consumers (MSC), and non-tobacco consumers (NTC), single-blind, cross-sectional study, included one overnight confinement of study subjects for Test Visit (Visit #3). No lifestyle changes were required, inclusive of tobacco habits. In addition to the Screening Visit (Visit #1), two other visits (Acceptance Visit [Visit #2] and a Test Visit [Visit #3]) were conducted at the clinical study site.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exclusive cigarette smokers | – | – |
| Exclusive moist snuff consumers | – | – |
| Non-tobacco consumers | – | – |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study target population included smokers (SMK), moist snuff consumers (MSC), and non-tobacco consumers (NTC), in generally good health, as determined by the Investigator. Exclusive tobacco smokers: n=40 Moist Snuff consumers: n=40 Non-tobacco consumers: n=40
Key inclusion criteria (21 listed)
- Males between 35 and 60 years of age, inclusive;
- Met cohort-specific requirements as follows:
- Subjects who are tobacco smokers: who did NOT intend to quit smoking nor intended to quit using moist snuff. "Intent to quit" was defined as planning a quit attempt within a month of screening.
- All subjects must have met the American Red Cross Blood Donation Eligibility Guidelines (64) (inclusive of, but not limited to, age, blood pressure, bleeding conditions, recent donation, and weight) and have been generally healthy and felt well with no restrictions or limitations on activities.
- Weighed at least 110 pounds.
Key exclusion criteria (34 listed)
- Met cohort specific exclusions as follows:
- Subjects who were tobacco consumers: expressed an interest in quitting smoking or using moist snuff (defined as planning a quit attempt within a month of screening).
- Subjects who were MSC users or non tobacco consumers: an ECO > 5 ppm at screening or study check-in (ECO of 6 to 10 ppm may not have been excluded based on joint review by the Sponsor and Investigator).
- Subjects who were smokers: an ECO < 10 ppm at screening or study check-in (ECO of 2 to 9 ppm may not have been excluded based on joint review by the Sponsor and Investigator).
- Any chronic illness that, in the opinion of the Investigator, is unstable.
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
Urinary Tobacco Exposure Biomarkers: Nicotine (NIC) and nine metabolites, Tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, mercapturic acid metabolites, and thiocyanate.
Time frame: Evening of Day -1, 24-hour urine collected within a 24 hour window prior to check-in
Tobacco-specific and tobacco-related biomarkers of exposure were evaluated.
Urinary Tobacco Exposure Biomarkers: Trace metals
Time frame: Morning of Day 1 (fasting) from the first morning void collection
Tobacco-related biomarkers of exposure were evaluated.
Buccal Cell Biomarkers
Time frame: Evening of Day -1, collected ~2 hours after 8:00pm check-in and start of 24 hour fast
The analyses from buccal cell biomarkers may include assessment of epigenetic changes.
Blood Biomarkers of Tobacco Exposure
Time frame: Morning of Day 1 (fasting) after first morning void was obtained
The biomarkers of tobacco exposure included Carboxyhemoglobin, Nicotine, Cotinine, and Thiocyanate.
Blood Biomarkers of Tobacco Effect
Time frame: Morning of Day 1 (fasting) after first morning void was obtained
The biomarkers of tobacco effect included Nitric Oxide Pathway, Coagulation Factors, Oxidative Stress, Inflammation Mediators, Lipids and Lipoproteins, and Hematology.
Saliva Biomarkers
Time frame: Morning of Day 1 (fasting), ~30 minutes after completion of blood collection and prior to buccal cell collection
The analyses from saliva biomarkers may include assessment of epigenetic changes, cytokine profiles, and other measures to assess the effects of tobacco usage.
Buccal Cell Biomarkers
Time frame: Morning of Day 1 (fasting), ~30 minutes after completion of blood collection and following saliva collection
The analyses from buccal cell biomarkers may include assessment of epigenetic changes.
Urinary Tobacco Exposure Biomarkers: Nicotine (NIC) and nine metabolites.
Time frame: Day 1 (fasting), Spot-urine collected ~2 hours after collection of first morning void and immediately following saliva/buccal collection
Tobacco-specific biomarkers of exposure were evaluated.
1 secondary outcome
Health status scores from self-administered questionnaires on health, nicotine dependence, diet history, tobacco product usage, and perceived stress.
Time frame: All questionnaires administered once on Evening of Day -1
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 19 Feb 2016.
- Results publication: PubMed 26495926Prasad GL, Jones BA, Chen P, Gregg EO. A cross-sectional study of biomarkers of exposure and effect in smokers and moist snuff consumers. Clin Chem Lab Med. 2016 Apr;54(4):633-42. doi: 10.1515/cclm-2015-0594.
- Derived from this study: PubMed 29771158Jessen WJ, Borgerding MF, Prasad GL. Global methylation profiles in buccal cells of long-term smokers and moist snuff consumers. Biomarkers. 2018 Nov;23(7):625-639. doi: 10.1080/1354750X.2018.1466367. Epub 2018 Jul 3.
- Derived from this study: PubMed 28193179Arimilli S, Madahian B, Chen P, Marano K, Prasad GL. Gene expression profiles associated with cigarette smoking and moist snuff consumption. BMC Genomics. 2017 Feb 14;18(1):156. doi: 10.1186/s12864-017-3565-1.
- Individual participant dataSharing planned: No
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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.
Melanie Fein, MD principal investigator
Mendenhall Clinical Research Center
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 Cigarette Smoking, run by R.J. Reynolds Tobacco Company 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 21 inclusion and 34 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 19 Feb 2016. 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.
What does the primary outcome measure?
Urinary Tobacco Exposure Biomarkers: Nicotine (NIC) and nine metabolites, Tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, mercapturic acid metabolites, and thiocyanate. (time frame: Evening of Day -1, 24-hour urine collected within a 24 hour window prior to check-in). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01923402, 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 19 Feb 2016.