BEHAVIORAL/PHARMACOLOGIC TREATMENT OF ALCOHOLISM

酗酒的行为/药物治疗

• 批准号: 2894223
• 负责人: JAMES D. HOSKING
• 金额: $ 109.99万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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/2894223
• 关键词: alcoholism /alcohol abuse therapy; biomedical facility; case history; clinical research; cognitive behavior therapy; cooperative study; data collection; data collection methodology /evaluation; data management; health administration; human subject; human therapy evaluation; interview; mental disorder diagnosis; outcomes research; statistics /biometry

DESCRIPTION: The primary objective of this proposal is to establish a clinical Coordinating Center for the Combined Behavioral/Pharmacologic Treatment of Alcoholism Patients (CBPTA) project within the Collaborative Studies Coordinating Center (CSCC) in the Department of Biostatistics at the University of North Carolina at Chapel Hill. The CSCC project team will collaborate in the development of the study protocol, manual of operations, and data collection forms, and provide administrative support for their development. We will take a leadership role in developing procedures for collecting, editing, storing, and analyzing data generated by the clinical Centers. We will develop procedures for eligibility verification and randomization, using an automated touchtone, voice response system. We will provide training to clinical Center staff in study procedures, including data collection and management, through a combination of written manuals and centralized and on-site training. We will design and implement quality control programs for diagnosis, intervention delivery, data collection, and central laboratory determinations. We will provide statistical expertise for study design and analysis and perform all data analysis. We will collaborate in the preparation of scientific publications and presentations. We will provide all necessary support to the Data and Safety Monitoring Board (DSMB), including production of interim analyses, and administrative support for Steering Committee meetings. We will organize and provide administrative support for Steering Committee and subcommittee meetings. We will manage procurement, packaging, and distribution of study medications. We will manage application for any necessary IND approval(s). We will develop appropriate procedures for sample and data transfer and quality control for central laboratory determinations.

描述：这项提议的主要目标是建立一个 行为/药理学相结合的临床协调中心 治疗酒精中毒患者(CBPTA)项目在协作组内 生物统计系研究协调中心(CSCC) 北卡罗来纳大学教堂山分校。 CSCC项目团队将合作开发这项研究 协议、操作手册和数据收集表格，并提供 为他们的发展提供行政支持。我们将发挥领导作用 在制定收集、编辑、存储和 分析临床中心生成的数据。我们将发展 资格验证和随机化的程序，使用 自动按键，语音应答系统。我们将提供培训，以 临床中心工作人员参与研究程序，包括数据收集和 通过书面手册和集中管理相结合的方式 现场培训。我们将设计和实施质量控制程序，以 诊断、干预交付、数据收集和中心实验室 决定。我们将为研究设计和研究提供统计专业知识 分析并执行所有数据分析。我们将在 编写科学出版物和演示文稿。我们将提供 向数据和安全监测委员会(DSMB)提供所有必要的支持； 包括中期分析的制作和行政支持 指导委员会会议。我们将组织和提供行政管理 为指导委员会和小组委员会会议提供支持。我们会设法做到的 研究药物的采购、包装和分发。我们会 管理必要的IND审批申请(S)。我们将发展 样品和数据传输及质量控制的适当程序 中央实验室测定。