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

在准备提交1996年12月的酒精研究中心（ARC）更新申请时，提出了一项试点研究：对于脑功能的几个依赖性指标，将检查呼气酒精浓度（BrAC）保持在80%时向基线值的恢复情况。BrAC钳夹使用口服负荷剂量和静脉输注林格氏乳酸盐中的乙醇的组合，以建立并维持BrAC在目标水平。 在过去的四年中，我们在IUSM进行了类似的IRB批准的初步研究，寻求对本研究进行单独IRB审查的理由是基于以下变更。 (1)钳夹的目标水平将为80%mg，而先前研究中为50mg%。(2)依赖性测量包括行为测量和神经心理测量，以及我们过去采用的事件相关电位和主观高度评价量表测量。(3)受试人群来自酒精人群遗传学合作。 本研究的具体目的是证明ARC应用中拟采用的样本人群的可行性，量化80 mg % BrAC时对酒精的急性耐受性，提供ARC提案中所需样本量估计数据，建立80 mg %时ERP和SHAS措施的测试/重测可靠性，并检查PR和N-Psy措施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.