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: * 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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
320
Moist Snuff product
Camel Snus product
Cigarette product
Avail Clinical Research
DeLand, Florida, United States
Comprehensive Clinical Development, Inc.
Miramar, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Central Kentucky Research Associates (CKRA)
Lexington, Kentucky, United States
Urine creatinine
To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 1 day of product usage
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No tobacco usage
MetaClin Research, Inc.
Austin, Texas, United States
Community Clinical Research
Austin, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 1 day of product usage