PILOT STUDY OF ACUTE TOLERANCE TO ALCOHOL USING BAC CLAMPING OF 80MG%

PILOT%20STUDY%20OF%20ACUTE%20TOLERANCE%20TO%20ALCOHOL%20USING%20BAC%20CLAMPING%20OF%2080MG%

• 批准号: 6117802
• 负责人: SEAN OCONNOR
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6117802
• 关键词: alcoholism /alcohol abuse; clinical research; drug metabolism; drug tolerance; ethanol; fatigue; functional ability; human subject; learning; pharmacokinetics

In preparation for submission of the Alcohol Research Center (ARC) renewal application, 12/96, a pilot study is proposed: for several dependent measures of brain function, recovery towards baseline values while the breath alcohol concentration (BrAC) is maintained at 80% will be examined. BrAC clamping uses a combination of an oral loading dose and intravenous infusion of ethanol in Ringer's lactate to establish and maintain a Br AC at the target level. We have conducted similar, IRB-approved pilot studies at IUSM over the last four years, and the rationale for seeking separate IRB review of this study is based on the following changes. (1) The target level of the clamp will be 80%mg, compared to 50mg% in previous studies. (2) The dependent measures include a behavioral measure and neuropsychological measures in addition to the event-related patential and subjective high assessment scale measures we have employed in the past. (3) the subject population is drawn from the collaboration on the genetics of alcohol population. The specific aims of the present study are to demonstrate feasibility in the sample population to be proposed in the ARC application, to quantify acute tolerance to alcohol at 80mg% Br AC, providing data for estimating the sample size required in the ARC proposal, to establish the test/retest reliability of ERP and SHAS measures at 80mg% and to examine PR and N-Psy measures for sensitivity to acute tolerance.

在准备提交酒精研究中心（ARC）更新 根据1996年12月的申请，提议进行一项试点研究： 脑功能的测量，恢复到基线值，而 呼气酒精浓度（BrAC）保持在80%将被检查。 BrAC钳夹使用口服负荷剂量和静脉内给药的组合。 在乳酸林格氏液中注入乙醇以建立和维持Br AC 在目标水平上。 我们已经进行了类似的，IRB批准的试点 研究在IUSM在过去四年中，以及寻求的理由 本研究的独立IRB审查基于以下变更。 （一） 钳夹的目标水平将为80%mg，而之前为50 mg 问题研究 (2)依赖性测量包括行为测量， 神经心理学测量除了事件相关的疼痛和 我们过去采用的主观性高的评估尺度。 (3)受试人群来自遗传学合作， 酒精人口。 本研究的具体目标是 证明ARC中拟定样本人群的可行性 应用，以量化对80 mg % Br AC的酒精的急性耐受性， 为估计ARC所需的样本量提供数据 建议，建立ERP和SHAS的测重信度 措施 80mg%并检查PR和N-Psy指标的敏感性 急性耐受性。