Smokeless Tobacco Use, Tobacco Dependence
Conditions
Keywords
Smokeless Tobacco, Biomarkers of tobacco exposure
Brief summary
The extent of toxicity varies considerably across different brands of smokeless tobacco (ST) products and data suggest that greater toxicity may result in greater health risks. However, little is known about the actual extent of exposure to toxicants from current smokeless tobacco products and factors that might moderate the extent of this exposure. The goals of this project are to address the following questions: 1. What are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior; 2. What are novel and the best measures of smokeless tobacco use, behavior and exposure; and 3. What are some of the determinants of smokeless tobacco use.
Detailed description
Study 1 is a multi-site descriptive study assessing tobacco toxicants in various smokeless tobacco products and tobacco toxicant exposure found in 600 subjects in three sites: University of MN Twin Cities, Oregon Research Institute in Eugene OR, and at West Virginia University in Morgantown, WV (200 subjects per site). The study will examine the relationship between brands of U.S. smokeless tobacco products that contain different levels of tobacco-specific nitrosamines (TSNAs), other carcinogens and nicotine, and biomarkers of exposure and effects on health (e.g., cardiovascular risk factors). Additionally, the study will examine factors that influence the extent of toxicant exposure and effect besides the levels of toxicants in the product. Subjects will attend an orientation where they will sign a consent form and then return for one clinic visit where they will provide blood (UMN only), urine samples, buccal samples and expectorated chews to be examined for nicotine levels, toxicant exposure and potential for tobacco-related health risks. A subsample of subjects (10 per brand of smokeless tobacco) will be asked for a tin of their unused product for testing (they will be reimbursed for the cost of their tin) and will be asked for three samples of expectorated chews that will be collected, frozen and shipped to the CDC where they will be analyzed for tobacco constituents. Subjects will complete several questionnaires on their tobacco use history, alcohol, diet, physical and mental health. Subjects will also keep a daily diary of their tobacco and alcohol use.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
University of Minnesota
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Using a consistent and daily amount of ST for the past year; 2. In good physical health (no unstable medical condition); 3. Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).
Exclusion criteria
1. Subjects must not be currently using other tobacco or nicotine products. 2. Female subjects cannot be pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | Three usual dip sized samples were collected from subjects at baseline | Two important harmful constituents in smokeless tobacco products are NNN + NNK, µg/g This measure reports the tobacco-specific nitrosamines (TSNA), N'-nitrosonornicotine (NNN), and 4- (methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) across 7 different smokeless tobacco brands. |
Countries
United States
Participant flow
Recruitment details
Daily users of certain smokeless tobacco products who were 18 years or older were recruited in Minneapolis/St. Paul, MN, Eugene, OR and Morgantown, WV via local advertisements. Subjects were recruited from 2/2010 through 5/2012.
Participants by arm
| Arm | Count |
|---|---|
| Smokeless Tobacco Users x | 359 |
| Total | 359 |
Baseline characteristics
| Characteristic | Smokeless Tobacco Users |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 352 Participants |
| Age, Continuous | 37.1 years STANDARD_DEVIATION 12.6 |
| Age of initiation | 17.7 years STANDARD_DEVIATION 8.5 |
| Duration of use | 13.9 years STANDARD_DEVIATION 11.9 |
| History of smoking >100 cigarettes | 350 Participants |
| Mean dips per day | 7.0 Mean dips per day STANDARD_DEVIATION 3.5 |
| Mean duration of dip | 69.3 minutes STANDARD_DEVIATION 42 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 331 Participants |
| Region of Enrollment United States | 359 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 357 Participants |
| Tins per wek | 3.6 tins per week STANDARD_DEVIATION 2.2 |
| Total nicotine equivalents (TNE) | 72.8 nmol/mg STANDARD_DEVIATION 70.9 |
| Total NNAL | 3.29 pmol/mg creatinine STANDARD_DEVIATION 3.77 |
| Total NNN | 0.284 pmol/mg creatinine STANDARD_DEVIATION 3.374 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands
Two important harmful constituents in smokeless tobacco products are NNN + NNK, µg/g This measure reports the tobacco-specific nitrosamines (TSNA), N'-nitrosonornicotine (NNN), and 4- (methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) across 7 different smokeless tobacco brands.
Time frame: Three usual dip sized samples were collected from subjects at baseline
Population: Products included samples from Copenhagen (Copenhagen Snuff, Copenhagen Long Cut, Copenhagen Long Cut Straight, Copenhagen Long Cut Wintergreen)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Copenhagen | Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | 2.4 ug/g |
| Skoal | Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | 2.25 ug/g |
| Kodiak | Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | 3.19 ug/g |
| Grizzly | Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | 5.51 ug/g |
| Red Seal | Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | 2.61 ug/g |
| Marlboro Snus | Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | 0.74 ug/g |
| Camel Snus | Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | 1.73 ug/g |