Novel Determinants and Measures of Smokeless Tobacco Use: Study 1
Parole chiave
Astratto
Descrizione
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.
Date
Ultimo verificato: | 04/30/2019 |
Primo inviato: | 02/09/2010 |
Iscrizione stimata inviata: | 02/09/2010 |
Primo pubblicato: | 02/10/2010 |
Ultimo aggiornamento inviato: | 04/30/2019 |
Ultimo aggiornamento pubblicato: | 05/02/2019 |
Data di inizio effettiva dello studio: | 01/31/2010 |
Data di completamento primaria stimata: | 03/31/2013 |
Data stimata di completamento dello studio: | 03/31/2013 |
Condizione o malattia
Fase
Criteri di idoneità
Età idonea per lo studio | 18 Years Per 18 Years |
Sessi idonei allo studio | All |
Metodo di campionamento | Non-Probability Sample |
Accetta volontari sani | sì |
Criteri | 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. |
Risultato
Misure di esito primarie
1. Extent of toxicity across 6 brands of smokeless tobacco [Baseline only]
Misure di esito secondarie
1. Testing novel and best measures to assess level of smokeless tobacco use behavior and exposure. [Baseline and history]
2. What are some of the determinants of smokeless tobacco use. [Baseline and history]