MEDICATION/PSYCHOTHERAPY TAILORED TO PATIENT RESOURCES

描述：本申请是对RFA的回应，“合并 酒精中毒的行为/药物治疗。虽然新药 正在被引入以减少酗酒者的酒精摄入量， 了解这些药物如何改变酒精摄入模式 和生活质量，什么样的患者特征可以最好地受益于这些 药物治疗和什么样的心理疗法将最终优化治疗 结果。本提案的具体目的是执行议定书 在RFA中描述，以检查1） 药物-心理治疗组合对患者结局的影响; 2） 假设变量可调节患者结局。拟议 随机临床试验，两种不同的心理疗法治疗 强度和范围，广谱治疗（BST）和动机 强化治疗将与四种药物条件相结合; 纳洛酮（NTX）、阿坎酸（ACA）、NTX+ACA和安慰剂。患者 治疗6个月，并随访对治疗的反应， 再加一年。测量的主要结果领域是1）禁欲， （2）社会心理功能。该提案还包括两个 旨在解决执行方面关键问题的试点研究 建议的RFA协议。试点1号将从大型 现有的数据集来衡量病人的心理社会资源。飞行员2是一个 NTX加ACA与安慰剂治疗6个月的随机试验， 酗酒者也接受BST。总的来说，我们预计， 治疗方案将是一个目标，最重要的是一个 患者的心理社会需求，同时解决生物方面的问题， 通过有效的药物管理实现酒精依赖。 为了满足主要研究要求，拟议试点 调查涉及三个目标：评估联合 阿坎酸和纳曲酮给药、中试和改进 BST，并制定一个强大而节俭的衡量病人 心理社会资源。

DESCRIPTION: This application is a response to the RFA, 'Combined Behavioral/Pharmacologic Treatment of Alcoholism. Although new medications are being introduced to decrease alcohol intake in alcoholics, little is known about how these medications actually change patterns of alcohol intake and quality of life, what patient profile can best benefit from these medications and what psychotherapies will ultimately optimize treatment outcome. The specific aim of this proposal is to implement the protocol described in the RFA to examine 1) the main effects of medication-psychotherapy combinations on patient outcomes and 2) the variables hypothesized to moderate patient outcome. In the proposed randomized clinical trial, two psychotherapies differing in treatment intensity and scope, Broad Spectrum therapy (BST) and Motivational Enhancement therapy will be combined with four medication conditions; Naltrexone (NTX), Acamprosate (ACA), NTX+ACA, and Placebo. Patients are treated for six months and response to treatment is followed for an additional one year. Primary outcome domains measured are 1) abstinence and g and 2) psychosocial functioning. Also included in this proposal are two pilot studies designed to address key questions regarding the implementation of the proposed RFA protocol. Pilot 1 will develop an instrument from large existing data sets to measure patient psychosocial resources. Pilot 2 is a randomized six month treatment trial of NTX plus ACA vs. placebo in alcoholics also receiving BST. Overall, we anticipate that the optimum treatment package will be one that targets the most significant of a patients psychosocial needs while addressing the biological aspects of alcohol dependence via effective medication management. In order to address the main study requirements, the proposed pilot investigation addresses three aims: assessing the effects of combined acamprosate and naltrexone administration, pilot testing and refinement of BST, and development of a robust yet parsimonious measure of patient psychosocial resources.