Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
关键词
抽象
描述
Forty apparently healthy smokers and non smokers (20 male, 20 female) will be recruited by advertising in the Twin Cities area. This will be done by the Tobacco Use Research Center. They will be screened in a phone call, then invited to come in for an orientation session at which consent will be obtained. Pregnant smokers will be excluded. They will visit the clinic weekly for 2 months and once monthly for 4 months for a total of 6 months participation.
At each visit they will drink 5 ml of 50:50 ethanol:water containing 10 ug [D10]phenanthrene. They will then collect their 24h urine and return it to the clinic. The urine will be analyzed for [D10]phenanthrene tetraol. The goal of the study is to determine the longitudinal stability of the amount of [D10]phenanthrene-tetraol in urine.
日期
最后验证: | 09/30/2014 |
首次提交: | 03/22/2010 |
提交的预估入学人数: | 03/23/2010 |
首次发布: | 03/24/2010 |
上次提交的更新: | 10/23/2014 |
最近更新发布: | 10/26/2014 |
实际学习开始日期: | 08/31/2007 |
预计主要完成日期: | 11/30/2011 |
预计完成日期: | 11/30/2011 |
状况或疾病
干预/治疗
Drug: Deuterated phenanthrene
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Smoked Deuterated Phenanthrene spiked in a study cigarette | |
Experimental: Oral Deuterated phenanthrene in an oral dose |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - smokers and non-smokers - smoking at least 10 cigarettes daily for the past year (for smokers) - in good physical health (no unstable medical condition) - stable, good mental health (not currently, within past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria). Exclusion Criteria: - subjects who have, within the past 6 months, experienced unstable or untreated psychiatric diagnoses, including substance abuse, as determined by the DSM-IV criteria. - subjects using any other tobacco or nicotine products. - female subjects who are pregnant or nursing. - subjects with an unstable medical condition. |
结果
主要结果指标
1. Pharmacokinetics [36 hours post dosing]