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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具有有效烟草使用史的受试者。有些要求将禁欲记录作为研究的组成部分,或者在治疗试验中作为结果的衡量标准。有些需要使用尼古丁,有些则需要使用各种药物,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。
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