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

为准备提交酒精研究中心（ARC）的续期申请（1996年12月），提出了一项试点研究：对脑功能的几个相关测量，将检查呼气酒精浓度（BrAC）保持在80%时向基线值恢复的情况。BrAC夹紧采用口服负荷剂量和静脉滴注林格氏乳酸乙醇相结合的方法来建立和维持BrAC在目标水平。在过去的四年里，我们在usm进行了类似的，经IRB批准的试点研究，并且寻求独立的IRB审查这项研究的理由是基于以下变化。(1)钳的目标水平为80%mg，而以往的研究为50mg%。(2)依赖测度除了过去使用的事件相关电位和主观高评价量表测度外，还包括行为测度和神经心理学测度。(3)受试者群体来自酒精群体遗传学合作。本研究的具体目的是证明在ARC申请中提出的样本群体的可行性，量化80mg% BrAC时对酒精的急性耐受性，为估计ARC申请所需的样品量提供数据，建立ERP和SHAS测量在80mg%时的测试/重新测试可靠性，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.