MEDICATION/PSYCHOTHERAPY TAILORED TO PATIENT RESOURCES

针对患者资源量身定制的药物/心理治疗

• 批准号: 2769247
• 负责人: RICHARD LONGABAUGH
• 金额: $ 5万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2769247
• 关键词: alcoholic beverage consumption; alcoholism /alcohol abuse; alcoholism /alcohol abuse chemotherapy; behavioral /social science research tag; clinical research; clinical trials; combination therapy; cooperative study; data collection methodology /evaluation; drug administration rate /duration; dyadic interaction; family structure /dynamics; functional ability; human subject; human therapy evaluation; longitudinal human study; motivation; naltrexone; outcomes research; psychological tests; psychotherapy; questionnaires; social support network; statistics /biometry; taurine; therapy compliance

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.

描述：本申请是对 RFA 的回应，“联合 酒精中毒的行为/药物治疗。虽然新药 正在引入减少酗酒者的酒精摄入量，但效果甚微 了解这些药物实际上如何改变酒精摄入模式 和生活质量，哪些患者特征最能从这些中受益 药物治疗以及哪些心理治疗将最终优化治疗 结果。该提案的具体目标是实施该协议 RFA 中描述的检查 1) 的主要影响 药物-心理治疗组合对患者结果的影响以及 2) 假设变量可以调节患者的预后。在提议的 随机临床试验，两种心理疗法的治疗效果不同 强度和范围、广谱疗法 (BST) 和激励 强化治疗将结合四种药物治疗情况； 纳曲酮 (NTX)、阿坎酸 (ACA)、NTX+ACA 和安慰剂。患者是 治疗六个月，并跟踪治疗反应 额外一年。测量的主要结果领域是 1) 禁欲和 g 和 2) 心理社会功能。该提案中还包括两个 旨在解决有关实施的关键问题的试点研究 拟议的 RFA 协议。试点1将开发一种大型仪器 用于衡量患者心理社会资源的现有数据集。飞行员 2 是 NTX 加 ACA 与安慰剂的随机六个月治疗试验 酗酒者也接受 BST。总的来说，我们预计最优的 治疗方案将针对最重要的一个 患者的心理社会需求，同时解决生物学方面的问题 通过有效的药物管理来治疗酒精依赖。 为了满足主要研究要求，拟议的试点 调查涉及三个目标： 评估综合措施的影响 阿坎酸和纳曲酮的管理、试点测试和改进 BST，以及开发一种稳健而简约的患者测量方法 社会心理资源。