NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK

描述：(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提案首次重新提交。我们将与至少10个现实世界的社区治疗计划(CTP)合作。CTP反映了不同的人口结构；有些是在农村或小城镇环境中。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)和国家发展和研究机构(NDRI)的研究人员、培训者和研究监督员的联盟，每个人都有各自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，并将负责进行临床试验的所有方面。描述了可以利用CTN独特范围的概念研究建议：1)针对患有内在性障碍的青少年药物滥用者的多模式CBT，以及2)针对可卡因依赖的司格利林/CBT。为了加强CTN对多中心、有效性研究设计的关注，我们指定Robert Hubbard博士为PI，并增加了DUMC-DCRI有效性研究专家团队，他们将扩大我们研究的包容性、概括性和实用性。

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.