NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK

（申请人摘要）这是在NIDA国家药物滥用临床试验网络中建立东南杜克节点的首次重新提交提案。我们将与至少10个现实世界的社区治疗项目（ctp）合作。ctp反映了不同的人口特征；有几家位于农村或小城镇。ctp不仅将实施现有的研究协议，还将与Node科学家合作开发新的研究概念。ctp的协调以及与其他节点和NIDA的接口将由一个区域研究和培训中心（RRTC）指导，该中心代表来自杜克大学医学中心（DUMC）精神病学系、杜克临床研究所（DCRI）和国家发展与研究所（NDRI）的研究人员、培训师和研究监督员联盟，每个机构都有自己的优势和相互合作的历史。RRTC将维护临床基础设施和研究基础设施，并负责开展临床试验的各个方面。可以利用CTN的独特范围描述的概念研究建议：1)多模式CBT治疗具有内化障碍的青少年药物滥用者，2)Selegiline/CBT治疗可卡因依赖。为了加强我们对CTN关注多中心有效性研究设计的贡献，我们已任命Robert Hubbard博士为PI，并增加了DUMC-DCRI有效性研究专家的核心，他们将扩大我们研究的包容性、普遍性和实用性。

DESCRIPTION: (Applicant's Abstract) This is the first resubmission of a proposal to establish a Southeastern Duke Node in the NIDA National Drug Abuse Clinical Trials Network. We will partner with at least 10 real world community-based treatment programs (CTPs). The CTPs reflect diverse demographics; several are in rural or small town settings. CTPs will not only implement existing research protocols but will collaborate with Node scientists to develop new research concepts. The coordination of the CTPs and the interface with other Nodes and NIDA will be directed by a Regional Research and Training Center (RRTC) that represents a confederation of investigators, trainers and research monitors from Duke University Medical Center (DUMC) Department of Psychiatry, the Duke Clinical Research Institute (DCRI), and the National Development and Research Institutes (NDRI) each with their own strengths and a history of collaborating with each other. The RRTC will maintain the clinical infrastructure and the research infrastructure and will be responsible for all aspects of conducting clinical trials. Concept research proposals that can utilize the unique scope of the CTN are delineated: 1) Multi-modal CBT for adolescent substance abusers with internalizing disorders and 2) Selegiline/CBT for cocaine dependence. To enhance our contribution to the CTN's focus on multi-center, effectiveness research designs, we have designated Dr. Robert Hubbard as PI and added a cadre of DUMC-DCRI experts on effectiveness research who will broaden the inclusiveness, generalizability and usefulness of our studies.