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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).
A total of approximately 320 subjects will be enrolled in parallel in one of the following 6 cohorts based on tobacco usage:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moist Snuff users | Other | Subjects for whom moist snuff is their usual brand of tobacco product. |
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| Camel Snus users | Other | Subjects for whom Camel Snus is their usual brand of tobacco product. |
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| Dual users of Camel Snus and cigarette | Other | Subjects who use both Camel Snus and cigarettes as their usual brands of tobacco products. |
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| Dual users of moist snuff and cigarettes | Other | Subjects who use both moist snuff and cigarettes as their usual brands of tobacco products. |
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| Cigarette smokers | Other | Subjects for whom cigarettes is their usual brand of tobacco product. |
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| Non-tobacco users | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moist Snuff | Other | Moist Snuff product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine creatinine | To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users. | 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. | 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. | 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. | 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. | 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. | After 1 day of product usage |
| 1,3 Butadiene metabolites in urine |
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Inclusion Criteria:
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).
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:
Exclusion Criteria:
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.
i. Clinically significant arthritis of the knee or hip.
ii. Claudication with walking 6 minutes or less.
iii. Clinically significant ambulation impairment as sequelae of cerebrovascular accident (CVA), sciatica, peripheral nervous disease, or myopathy.
iv. 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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbette Jones, DrPH | RAIS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avail Clinical Research | DeLand | Florida | 32720 | United States | ||
| Comprehensive Clinical Development, Inc. |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Subjects who do not use tobacco products.
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| Camel Snus | Other | Camel Snus product |
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| Cigarettes | Other | Cigarette product |
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| No tobacco usage | Other | No tobacco usage |
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To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | After 1 day of product usage |
| Miramar |
| Florida |
| 33025 |
| United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Central Kentucky Research Associates (CKRA) | Lexington | Kentucky | 40509 | United States |
| MetaClin Research, Inc. | Austin | Texas | 78749 | United States |
| Community Clinical Research | Austin | Texas | 78754 | United States |