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中文摘要
翻译
TTURC支持的大多数人体研究都需要招募有确凿烟草使用史的受试者。有些人要求将禁欲作为研究的一个组成部分,或者在治疗试验中作为结果的衡量标准。一些人需要尼古丁的管理,而另一些人则需要各种药物,要么作为尼古丁作用的探针,要么作为戒烟试验的潜在疗法。所有人都受益于获得药物浓度,作为药物暴露的客观衡量标准。 核心实验室将测量血清或尿液中可替宁的浓度,作为慢性尼古丁暴露的客观衡量标准和长期戒烟的标志。这些措施对于在招募受试者的同时可靠地量化先前的烟草接触情况、确保治疗部门之间的一致性以及可靠地记录戒烟作为治疗研究或戒烟和复发机制调查的结果至关重要。核心实验室的血清尼古丁测量将允许对尼古丁暴露的急性测量,记录急性戒断,并进行尼古丁给药研究,有助于解释药物处置的个体差异。同样,在戒烟研究中测量药物浓度将允许对依从性进行客观评估。对血浆浓度的了解也可能有助于解释反应和/或毒性的变化。测量用于尖锐探测或扰乱尼古丁作用途径的药物将允许评估不同治疗组之间药物暴露的可能差异。 核心实验室为原本侧重于行为和/或神经科学的研究提供了跨学科的药理学/药物研究视角,还可以提高此类研究的信息价值,使其超越调查的主要目标。由于共同的分析方法和目标被用来支持多个项目,因此有机会整合不同研究的数据。
英文摘要
Most of the human studies supported by the TTURC entail the recruitment of subjects with a validated history of tobacco use. Some require documentation of abstinence either as a component of the study, or, in treatment trials, as a measure of outcome. Some require adminstration of nicotine, and others, various drugs, either as probes of nicotine's action, or as potential therapies in smoking cessation trials. All benefit from access to drug concentrations as an objective measure of drug exposure. The core laboratory will measure concentrations of cotinine in serum or urine as an objective measure of chronic nicotine exposure and marker of extended abstinence. These measures are essential to reliably quantify prior tobacco exposure in conjunction with subject recruitment, assure concordance between treatment arms, and to reliably document abstinence as an outcome in treatment studies or for investigations into the mechanisms of abstinence and relapse. Serum nicotine measurements by the core laboratory will allow for acute measurement of nicotine exposure, document acute abstinence, and for nicotine administration studies, help to account for interindividual differences in drug disposition. Similarly, measurement of concentrations of drugs in smoking cessation studies will allow an objective assessment of compliance. Knowledge of plasma concentrations may also help to explain variations in response and/or toxicity. Measurement of drugs used to acutely probe or perturb pathways involved in nicotine's actions will allow assessment of possible differences in drug exposure between treatment groups. The core laboratory provides a transdisciplinary pharmacology/drug esposure perspective to studies otherwise focused on behavior and/or neuroscience, and can also enhance the informational value of such studies beyond that of the primary goals of the investigation. Since common methodology and targets for analysis are used to support multiple projects, there are opportunities to integrate data across studies.
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Ethanol metabolites for monitoring drinking in clinical trials.
  • 批准号:
    8051800
  • 项目类别:
  • 资助金额:
    $39.62万
  • 财政年份:
    2010
  • 负责人:
    PETER I JATLOW
  • 依托单位:
Ethanol metabolites for monitoring drinking in clinical trials.
  • 批准号:
    8242781
  • 项目类别:
  • 资助金额:
    $31.21万
  • 财政年份:
    2010
  • 负责人:
    PETER I JATLOW
  • 依托单位:
Ethanol metabolites for monitoring drinking in clinical trials.
  • 批准号:
    7766407
  • 项目类别:
  • 资助金额:
    $40.33万
  • 财政年份:
    2010
  • 负责人:
    PETER I JATLOW
  • 依托单位:
Core--Analytical Laboratory
  • 批准号:
    6864154
  • 项目类别:
  • 资助金额:
    $12.7万
  • 财政年份:
    2004
  • 负责人:
    PETER I JATLOW
  • 依托单位:
海外基金