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

为了准备提交酒精研究中心(ARC)的续签申请，12/96，提出了一项试点研究：对于大脑功能的几个依赖指标，将检查在呼气酒精浓度(BRAC)保持在80%的情况下恢复到基线水平。BRAC夹闭使用口服负荷量和在林格氏乳酸中静脉输注乙醇的组合，以建立并维持目标水平的BRAC。在过去的四年里，我们在IUSM进行了类似的IRB批准的试点研究，寻求IRB对这项研究进行单独审查的理由基于以下变化。(1)夹子的目标水平将是80%，而以前的研究是50%。(2)依从性测量除以往采用的事件相关电位和主观高评定量表测量外，还包括行为测量和神经心理测量。(3)受试者群体来源于酒精群体遗传学合作。本研究的具体目的是论证ARC应用中提出的样本人群的可行性，量化80 mg%BRAC的急性酒精耐受性，为估计ARC建议所需的样本量提供数据，建立80 mg%的ERP和SHAS测量的测试/重测可靠性，并检查PR和N-Psy测量对急性耐受性的敏感性。

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 BrAC 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 potential 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% BrAC, to provide 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.