Novel Determinants and Measures of Smokeless Tobacco Use: Study 1
کلید واژه ها
خلاصه
شرح
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.
تاریخ
آخرین تأیید شده: | 04/30/2019 |
اولین ارسال: | 02/09/2010 |
ثبت نام تخمینی ارسال شد: | 02/09/2010 |
اولین ارسال: | 02/10/2010 |
آخرین بروزرسانی ارسال شده: | 04/30/2019 |
آخرین به روزرسانی ارسال شده: | 05/02/2019 |
تاریخ شروع مطالعه واقعی: | 01/31/2010 |
تاریخ تخمین اولیه اولیه: | 03/31/2013 |
تاریخ برآورد مطالعه: | 03/31/2013 |
شرایط یا بیماری
فاز
معیارهای صلاحیت
سنین واجد شرایط تحصیل | 18 Years به 18 Years |
جنسیت واجد شرایط مطالعه | All |
روش نمونه گیری | Non-Probability Sample |
داوطلبان سالم را می پذیرد | آره |
شاخص | 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. |
نتیجه
اقدامات اولیه
1. Extent of toxicity across 6 brands of smokeless tobacco [Baseline only]
اقدامات ثانویه
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]