Smoking, TobaccoNCT04255459
Post-Market Surveillance of Tobacco Products
A study testing Moist Snuff, Camel Snus and Cigarettes in people with Smoking, Tobacco and Smoking Behaviors, run by RAI Services Company at 6 sites in United States.
Trial summary
This is a multicenter, post market surveillance study designed to evaluate biomarkers of tobacco exposure and effect, health status measurements, and tobacco product usage patterns in subjects who are natural adopters of cigarettes and/or smokeless tobacco. Non tobacco users will serve as a non use comparison group. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco, Smoking Behaviors
- What is being tested?
- Moist Snuff, Camel Snus and Cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Feb 2010to 14 Aug 2010
- Phase
- Interventional
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign an informed consent form.
- Male or female subjects at least 19 years of age.
- Able to safely perform all study procedures, as determined by the site Investigator.
- Willing to perform all study procedures and to consume only the meals/snacks provided while confined to the clinic.
- Agree to not use drugs of abuse over the course of the study, and test negative for drugs of abuse.
- Test negative for breath alcohol (by breathalyzer).
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- For tobacco users: do NOT intend to quit smoking nor intend to quit using oral smokeless tobacco products (STP) leading up to study participation (defined as planning a quit attempt within a month of the Initial Screening Visit).
- For tobacco users: willing to abstain from tobacco use for up to 10 hours during overnight confinement in the clinic.
- Able to read, understand, and complete questionnaires in English.
- Meet cohort specific requirements as follows:
- Moist Snuff Users: Must be exclusive moist snuff users of any brand, any style, and any flavor who self-report using on average ≥ 1 can per week for at least 6 months prior to study entry, have an expired carbon monoxide (ECO) level of 0 to 5 ppm, and have a positive urine cotinine screen. Note: Subjects with an ECO level of 6 to 10 ppm may be included upon joint review by the Sponsor and Investigator.
- Camel SNUS Users: Must be exclusive Camel SNUS users of any variety who self report using on average ≥ 1 tin per week for at least 6 months prior to study entry, have an ECO level of 0 to 5 ppm, and have a positive urine cotinine screen. Note: Subjects with an ECO level of 6 to 10 ppm may be included upon joint review by the Sponsor and Investigator.
- Dual Camel SNUS/Cigarette Users: Must be dual users of Camel SNUS and allowed commercial filtered tobacco burning cigarettes, using on average ≥ 1 tin of Camel SNUS per week and smoking ≥ 5 cigarettes daily for at least 6 months prior to study entry. The subject's ECO level must be from 5 to 100 ppm, and the urine cotinine screen must be positive.
- Dual Moist Snuff/Cigarette Users: Must be dual users of moist snuff and allowed commercial filtered tobacco burning cigarettes, using on average ≥ 1 can of snuff per week and smoking ≥ 5 cigarettes daily for at least 6 months prior to study entry. The subject's ECO level must be from 5 to 100 ppm, and the urine cotinine screen must be positive.
- Cigarette Smokers: Must be exclusive cigarette smokers (of allowed commercial filtered tobacco burning cigarettes) who self-report smoking on average ≥ 10 cigarettes daily for at least 6 months prior to study entry, have an ECO level of 10 to 100 ppm, and have a positive urine cotinine screen.
- Non Tobacco Users: Must be non tobacco users for at least 12 months prior to study entry with an ECO level of 0 to 5 ppm, and have a negative urine cotinine screen. Note: Subjects with an ECO level of 6 to 10 ppm may be included upon joint review by the Sponsor and Investigator.
Who cannot join
- Use of any type of non-tobacco nicotine-containing product/device (e.g., electronic cigarette) or any nicotine replacement therapy (e.g., nicotine patch, nicotine gum, nicotine spray, nicotine inhaler or nicotine lozenge) within 6 months prior to study entry or during the study.
- Unable to safely perform the study procedures, as determined by the site Investigator. In general, subjects with any of the conditions listed below will be excluded unless individually approved by the Medical Monitor.
- Uncontrolled hypertension (blood pressure > 170/110 mmHg at the Initial Screening Visit).
- Unstable coronary artery disease (Class III-IV angina).
- Decompensated (Class III-IV) congestive heart failure.
- Morbid obesity (body mass index [BMI] ≥ 40 kg/m2).
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- Uncontrolled diabetes (HgbA1c > 9.0).
- Pulmonary disease requiring oxygen therapy or preventing 6 minutes of steady ambulation or preventing completion of triplicate spirometry.
- Reduced mobility that impairs satisfactory completion of the 6MWT (six minute walk test), such as:
- Clinically significant arthritis of the knee or hip.
- Claudication with walking 6 minutes or less.
- Clinically significant ambulation impairment as sequelae of cerebrovascular accident (CVA), sciatica, peripheral nervous disease, or myopathy.
- Imbalance or other gait disorder requiring assistance of a cane or walker to ambulate.
- Have a resting heart rate (after being seated for at least 5 minutes) of > 120 beats per minute (bpm).
- Had a myocardial infarction within the month prior to the Initial Screening Visit through enrollment into the study.
- Have self reported or clinical indications of psychiatric disorders deemed clinically significant by the site Investigator.
- Unwilling to perform the study procedures.
- For females: intend to get pregnant during study period, or are currently pregnant or breast feeding.
- For cigarette- and dual-users:
- use of any charcoal-filtered cigarette (i.e., brands such as Lark, Kent, etc., with the word "charcoal" on the package),
- use of any crush-capsule cigarette (such as Camel Crush or Pall Mall Crush), or
- use of any non tobacco burning cigarette, including tobacco heating cigarettes (such as Eclipse, Accord, etc.) or electronic cigarettes (e-cigarettes such as Smoking Anywhere, Gamucci, NJOY, etc.).
- For tobacco users: express an interest in quitting smoking or using oral smokeless tobacco (defined as planning a quit attempt within a month of the Initial Screening Visit).
- Have participated in a clinical study and/or received an investigational product within 30 days of the Initial Screening Visit.
- Meet cohort specific exclusions as follows:
- Moist Snuff Users: For 6 months prior to the study through Day 1, the use of any other tobacco- or nicotine-containing product or device other than moist snuff (of any brand, style, and flavor), including tobacco-burning cigarettes, tobacco-heating cigarettes, e cigarettes, cigars, pipes, chewing tobacco, dry snuff, snus, etc.; a negative urine cotinine screen; or an ECO greater than 5 ppm (ECO of 6 to 10 ppm may not exclude based upon joint review by the Sponsor and Investigator).
- Camel SNUS Users: For 6 months prior to the study through Day 1, the use of any tobacco- or nicotine-containing product or device other than Camel SNUS (of any variety), including tobacco-burning cigarettes, tobacco-heating cigarettes, e cigarettes, cigars, pipes, chewing tobacco, dry snuff, moist snuff, other snus brands, etc.; a negative urine cotinine screen; or an ECO greater than 5 ppm (ECO of 6 to 10 ppm may not exclude based upon joint review by the Sponsor and Investigator).
- Dual Camel SNUS/Cigarette Users: For 6 months prior to the study through Day 1, the use of any tobacco- or nicotine-containing product or device other than Camel SNUS (of any variety) and tobacco burning cigarettes (allowed commercial filtered cigarettes), including tobacco-heating cigarettes, e cigarettes, cigars, pipes, chewing tobacco, dry snuff, moist snuff, other snus brands, etc.; a negative urine cotinine screen; or an ECO less than 5 or greater than 100 ppm.
- Dual Moist Snuff/Cigarette Users: For 6 months prior to the study through Day 1, the use of any tobacco- or nicotine-containing product or device other than moist snuff (of any brand, style, and flavor) and tobacco burning cigarettes (allowed commercial filtered cigarettes), including tobacco-heating cigarettes, e cigarettes, cigars, pipes, chewing tobacco, dry snuff, snus, etc.; a negative urine cotinine screen; or an ECO less than 5 or greater than 100 ppm.
- Cigarette Smokers: For 6 months prior to the study through Day 1, the use of any tobacco- or nicotine-containing product or device other than tobacco burning cigarettes (allowed commercial filtered cigarettes), including tobacco-heating cigarettes, e cigarettes, cigars, pipes, chewing tobacco, dry snuff, moist snuff, snus, etc.; a negative urine cotinine screen; or an ECO less than 10 or greater than 100 ppm.
- Non Tobacco Users: In their lifetime, the use of more than 20 packs of cigarettes; the use of more than 10 cans, tins, or packs of any smokeless tobacco (chewing tobacco, dry snuff, moist snuff, snus); the use of more than 20 cigars; the use of more than 20 pipes of tobacco; the use of any nicotine replacement therapy, the use of any e cigarette, or use of any combination thereof; a positive urine cotinine screen; or an ECO greater than 5 ppm (ECO of 6 to 10 ppm may not exclude based upon joint review by the Sponsor and Investigator).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
MetaClin Research, Inc.
Austin, Texas, 78749
Community Clinical Research
Austin, Texas, 78754
Avail Clinical Research
DeLand, Florida, 32720
Central Kentucky Research Associates (CKRA)
Lexington, Kentucky, 40509
Comprehensive Clinical Development, Inc.
Miramar, Florida, 33025
Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
Official title: Post-Market Surveillance of Tobacco Products: A Multicenter Clinical Trial of Natural Adopters of Cigarettes, Moist Snuff, Camel SNUS, and Dual Use
This is a multicenter, post market surveillance study designed to evaluate biomarkers of tobacco exposure and effect, health status measurements, and tobacco product usage patterns in subjects who are natural adopters of cigarettes and/or smokeless tobacco. Non tobacco users will serve as a non use comparison group. This study is unblinded by necessity due to the very different visual appearance of the subject's Usual Brand (UB) of tobacco product(s).
Read the detailed description
A total of approximately 320 subjects will be enrolled in parallel in one of the following 6 cohorts based on tobacco usage:
- Exclusive moist snuff users (n=50)
- Exclusive Camel SNUS users (n=50)
- Dual users of Camel SNUS and cigarettes (n=50)
- Dual users of moist snuff and cigarettes (n=50)
- Exclusive cigarette smokers (n=40 males and 20 females)
- Non tobacco users (n=40 males and 20 females)
The study duration will be 5.5 weeks or less, depending upon the study procedures required for the subject's specific cohort. The study duration includes screening up to 35 days prior to clinic check in (Day 1) and a 2 day confinement period of approximately 24 hours (Day 1 and Day 2). Subjects will be discharged in the morning on Day 2.
At the Initial Screening Visit, clinical study staff will perform screening assessments. Tobacco users will be instructed to provide a sufficient supply of their UB product(s) for use during pre-clinic procedures (i.e., pre-clinic used tobacco product collections) and for use during clinic confinement.
Prior to checking in for clinic confinement, subjects will return to the clinic for a Pre-Enrollment Outpatient Visit to assess enrollment eligibility related to the safe completion of triplicate spirometry and to pick up used tobacco product collection kits and/or urine collection containers for pre-clinic collection procedures. Within 14 days prior to clinic admission, subjects will be instructed, depending on their tobacco cohort, to continue smoking and/or using Camel SNUS or moist snuff at their normal rates and to collect their used cigarette butts (1 day collection) and/or used snus pouches (7 day collection), and retain the labeled snuff containers (1 day usage). Subjects will turn in their used tobacco product collections upon clinic check in.
Subjects will report to the clinical research unit in the morning on Day 1 for baseline testing, confirmation of continued study eligibility, check in of their UB tobacco product(s), and return of their urine collection containers and used tobacco product collections. Subjects will be allowed to use their UB tobacco product(s) ad libitum; tobacco products will be stored by clinic staff and will be dispensed subsequent to subject request, as allowed during scheduled study procedures (i.e., questionnaires, spirometry, carboxyhemoglobin, 6MWT [six-minute walk test]). Each UB product usage will be recorded. At approximately 2200, fasting (from all food and drink except water) and tobacco abstention will begin. Subjects must agree to remain abstinent for approximately 8-10 hours and until all Day 2 fasting procedures (i.e., samples for biomarkers of tobacco effect and exposure) have been completed.
- Conditions
- Smoking, Tobacco, Smoking Behaviors
- Being tested
- Moist Snuff, Camel Snus, Cigarettes, No tobacco usage
- Medical subject headings
- Tobacco Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moist SnuffOther
Moist Snuff product
Camel SnusOther
Camel Snus product
CigarettesOther
Cigarette product
No tobacco usageOther
No tobacco usage
| Study group | Role | What they receive |
|---|---|---|
| Moist Snuff users | Other | Subjects for whom moist snuff is their usual brand of tobacco product. Receives: Other: Moist Snuff |
| Camel Snus users | Other | Subjects for whom Camel Snus is their usual brand of tobacco product. Receives: Other: Camel Snus |
| Dual users of Camel Snus and cigarette | Other | Subjects who use both Camel Snus and cigarettes as their usual brands of tobacco products. Receives: Other: Camel Snus; Other: Cigarettes |
| Dual users of moist snuff and cigarettes | Other | Subjects who use both moist snuff and cigarettes as their usual brands of tobacco products. Receives: Other: Moist Snuff; Other: Cigarettes |
| Cigarette smokers | Other | Subjects for whom cigarettes is their usual brand of tobacco product. Receives: Other: Cigarettes |
| Non-tobacco users | Other | Subjects who do not use tobacco products. Receives: Other: No tobacco usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine creatinine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Urine nicotine and 9 metabolites
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Tobacco specific nitrosamines in urine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Acrolein metabolite and acrylamide metabolites in urine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Crotonaldehyde metabolite in urine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Benzene metabolite in urine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
1,3 Butadiene metabolites in urine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Aromatic amines in urine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Polycyclic aromatic hydrocarbons metabolites in urine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Thiocyanate in urine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Urinary mutagen uptake in strains TA98 and YG1024
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Isoprostanes and metabolites; prostaglandin PGF2alpha in urine
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Blood nicotine and cotinine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Thiocyanate in blood
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Carboxyhemoglobin in blood
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
4-Aminobiphenyl hemoglobin adducts in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Amino Acids in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Glycated hemoglobin in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Total cholesterol in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Triglycerides in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Low density lipoprotein cholesterol in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
High density lipoprotein cholesterol in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Very low density lipoprotein cholesterol in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Apolipoprotein A1 in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Apolipoprotein A2 in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Apolipoprotein B100 in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Lipoprotein(a) in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Oxidized low density lipoprotein in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Folate in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Fibrinogen in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Tissue inhibitor of metalloproteinase 1 in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
hsC-reactive protein in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
alpha-1-antitrypsin in blood
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Tar (mg/day) and nicotine (mg/day) from subject's in-clinic cigarette use OR nicotine (mg/day) from subject's in-clinic snus use
To establish baseline values for mouth-level exposure of natural adopters for the product classes of cigarettes and snus.
Measured: After 1 day of product usage
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by the Dyspnea Modified Borg Scale, pre- and post-6MWT.
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by the Overall Fatigue Modified Borg Scale, pre- and post-6MWT.
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by heart rate (beats/minute), pre- and post-6MWT.
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by oxygen saturation (% SpO2), pre- and post-6MWT.
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by spirometry (FEV1 % predicted), pre- and post-6MWT.
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by spirometry (FEV1 /FVC ratio), pre- and post-6MWT.
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Current self-reported health status as measured by the Fagerström Test for Nicotine Dependence.
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Current self-reported health status as measured by the Smoking Cessation Quality of Life Questionnaire (SCQoL, inclusive of the Short Form Health Survey [SF-36v2]).
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Current self-reported health status as measured by the American Thoracic Society Division of Lung Disease Questionnaire (ATS-DLD-78-A).
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Measured: After 1 day of product usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start13 Feb 2010
- Primary completion14 Aug 2010
- Study completion14 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
- More trials run by RAI Services CompanyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bobbette Jones, DrPH, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255459
- Sponsor's protocol ID
- CSD0904
- Status last verified
- Jan 2020
- First submitted
- 4 Sep 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Surveillance of Tobacco Products: A Multicenter Clinical Trial of Natural Adopters of Cigarettes, Moist Snuff, Camel SNUS, and Dual Use
- ClinicalTrials.gov ID
- NCT04255459
- Acronym / sponsor ID
- CSD0904
- Conditions
- Smoking, Tobacco, Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2010 (actual)
- Primary completion
- 14 Aug 2010 (actual)
- Study completion
- 14 Aug 2010 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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 is a multicenter, post market surveillance study designed to evaluate biomarkers of tobacco exposure and effect, health status measurements, and tobacco product usage patterns in subjects who are natural adopters of cigarettes and/or smokeless tobacco. Non tobacco users will serve as a non use comparison group. This study is unblinded by necessity due to the very different visual appearance of the subject's Usual Brand (UB) of tobacco product(s).
Detailed description
A total of approximately 320 subjects will be enrolled in parallel in one of the following 6 cohorts based on tobacco usage:
- Exclusive moist snuff users (n=50)
- Exclusive Camel SNUS users (n=50)
- Dual users of Camel SNUS and cigarettes (n=50)
- Dual users of moist snuff and cigarettes (n=50)
- Exclusive cigarette smokers (n=40 males and 20 females)
- Non tobacco users (n=40 males and 20 females)
The study duration will be 5.5 weeks or less, depending upon the study procedures required for the subject's specific cohort. The study duration includes screening up to 35 days prior to clinic check in (Day 1) and a 2 day confinement period of approximately 24 hours (Day 1 and Day 2). Subjects will be discharged in the morning on Day 2.
At the Initial Screening Visit, clinical study staff will perform screening assessments. Tobacco users will be instructed to provide a sufficient supply of their UB product(s) for use during pre-clinic procedures (i.e., pre-clinic used tobacco product collections) and for use during clinic confinement.
Prior to checking in for clinic confinement, subjects will return to the clinic for a Pre-Enrollment Outpatient Visit to assess enrollment eligibility related to the safe completion of triplicate spirometry and to pick up used tobacco product collection kits and/or urine collection containers for pre-clinic collection procedures. Within 14 days prior to clinic admission, subjects will be instructed, depending on their tobacco cohort, to continue smoking and/or using Camel SNUS or moist snuff at their normal rates and to collect their used cigarette butts (1 day collection) and/or used snus pouches (7 day collection), and retain the labeled snuff containers (1 day usage). Subjects will turn in their used tobacco product collections upon clinic check in.
Subjects will report to the clinical research unit in the morning on Day 1 for baseline testing, confirmation of continued study eligibility, check in of their UB tobacco product(s), and return of their urine collection containers and used tobacco product collections. Subjects will be allowed to use their UB tobacco product(s) ad libitum; tobacco products will be stored by clinic staff and will be dispensed subsequent to subject request, as allowed during scheduled study procedures (i.e., questionnaires, spirometry, carboxyhemoglobin, 6MWT [six-minute walk test]). Each UB product usage will be recorded. At approximately 2200, fasting (from all food and drink except water) and tobacco abstention will begin. Subjects must agree to remain abstinent for approximately 8-10 hours and until all Day 2 fasting procedures (i.e., samples for biomarkers of tobacco effect and exposure) have been completed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Moist Snuff users | Other | Other: Moist SnuffSubjects for whom moist snuff is their usual brand of tobacco product. |
| Camel Snus users | Other | Other: Camel SnusSubjects for whom Camel Snus is their usual brand of tobacco product. |
| Dual users of Camel Snus and cigarette | Other | Other: Camel Snus, Other: CigarettesSubjects who use both Camel Snus and cigarettes as their usual brands of tobacco products. |
| Dual users of moist snuff and cigarettes | Other | Other: Moist Snuff, Other: CigarettesSubjects who use both moist snuff and cigarettes as their usual brands of tobacco products. |
| Cigarette smokers | Other | Other: CigarettesSubjects for whom cigarettes is their usual brand of tobacco product. |
| Non-tobacco users | Other | Other: No tobacco usageSubjects who do not use tobacco products. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able to comprehend and willing to sign an informed consent form.
- Male or female subjects at least 19 years of age.
- Able to safely perform all study procedures, as determined by the site Investigator.
- Willing to perform all study procedures and to consume only the meals/snacks provided while confined to the clinic.
- Agree to not use drugs of abuse over the course of the study, and test negative for drugs of abuse.
Key exclusion criteria (31 listed)
- Use of any type of non-tobacco nicotine-containing product/device (e.g., electronic cigarette) or any nicotine replacement therapy (e.g., nicotine patch, nicotine gum, nicotine spray, nicotine inhaler or nicotine lozenge) within 6 months prior to study entry or during the study.
- Unable to safely perform the study procedures, as determined by the site Investigator. In general, subjects with any of the conditions listed below will be excluded unless individually approved by the Medical Monitor.
- Have a resting heart rate (after being seated for at least 5 minutes) of > 120 beats per minute (bpm).
- Had a myocardial infarction within the month prior to the Initial Screening Visit through enrollment into the study.
- Have self reported or clinical indications of psychiatric disorders deemed clinically significant by the site Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moist SnuffMoist Snuff product | Other | Dual users of moist snuff and cigarettes, Moist Snuff users |
| Camel SnusCamel Snus product | Other | Camel Snus users, Dual users of Camel Snus and cigarette |
| CigarettesCigarette product | Other | Cigarette smokers, Dual users of Camel Snus and cigarette, Dual users of moist snuff and cigarettes |
| No tobacco usageNo tobacco usage | Other | Non-tobacco users |
Primary outcome
Urine creatinine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Urine nicotine and 9 metabolites
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Tobacco specific nitrosamines in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Acrolein metabolite and acrylamide metabolites in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Crotonaldehyde metabolite in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Benzene metabolite in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
1,3 Butadiene metabolites in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Aromatic amines in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Polycyclic aromatic hydrocarbons metabolites in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Thiocyanate in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Urinary mutagen uptake in strains TA98 and YG1024
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Isoprostanes and metabolites; prostaglandin PGF2alpha in urine
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Blood nicotine and cotinine
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Thiocyanate in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Carboxyhemoglobin in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
4-Aminobiphenyl hemoglobin adducts in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Amino Acids in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Glycated hemoglobin in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Total cholesterol in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Triglycerides in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Low density lipoprotein cholesterol in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
High density lipoprotein cholesterol in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Very low density lipoprotein cholesterol in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Apolipoprotein A1 in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Apolipoprotein A2 in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Apolipoprotein B100 in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Lipoprotein(a) in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Oxidized low density lipoprotein in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Folate in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Fibrinogen in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Tissue inhibitor of metalloproteinase 1 in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
hsC-reactive protein in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
alpha-1-antitrypsin in blood
Time frame: After 1 day of product usage
To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.
Tar (mg/day) and nicotine (mg/day) from subject's in-clinic cigarette use OR nicotine (mg/day) from subject's in-clinic snus use
Time frame: After 1 day of product usage
To establish baseline values for mouth-level exposure of natural adopters for the product classes of cigarettes and snus.
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by the Dyspnea Modified Borg Scale, pre- and post-6MWT.
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by the Overall Fatigue Modified Borg Scale, pre- and post-6MWT.
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by heart rate (beats/minute), pre- and post-6MWT.
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by oxygen saturation (% SpO2), pre- and post-6MWT.
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by spirometry (FEV1 % predicted), pre- and post-6MWT.
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by spirometry (FEV1 /FVC ratio), pre- and post-6MWT.
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Current self-reported health status as measured by the Fagerström Test for Nicotine Dependence.
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Current self-reported health status as measured by the Smoking Cessation Quality of Life Questionnaire (SCQoL, inclusive of the Short Form Health Survey [SF-36v2]).
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
Current self-reported health status as measured by the American Thoracic Society Division of Lung Disease Questionnaire (ATS-DLD-78-A).
Time frame: After 1 day of product usage
To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.
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 5 Feb 2020.
- 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.
Bobbette Jones, DrPH study director
RAIS
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moist Snuff, Camel Snus and Cigarettes in people with Smoking, Tobacco and Smoking Behaviors, run by RAI Services Company at 6 sites 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 16 inclusion and 31 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Urine creatinine (time frame: After 1 day of product usage). The study lists 43 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.