transision and completion clinical trial

药物开发是国家酒精滥用和酒精中毒研究所（NIAAA）的一个高度优先项目。目前，只有3种药物被美国食品和药物管理局（FDA）批准用于治疗酒精依赖。这些药物在临床试验中表现出小到中等的效果，并不适用于所有人。因此，寻找新的分子靶点和更有效的药物至关重要。NIAAA临床研究小组（NCIG）计划的创建由NIAAA药物开发校外咨询委员会（理事会的一个小组委员会）于2005年2月7日至8日建议，随后于2005年6月获得整个NIAAA国家咨询理事会的批准。理事会认识到迫切需要一个快速有效的机制，对有希望治疗酒精依赖的化合物进行概念验证试验。为了完成这一使命，授权一个合同机制为NCIG项目提供资金，其中包括一个数据协调中心和一个经验丰富的临床试验中心网络。NIAAA的使命是开发安全有效的药物来治疗各种人群的酒精使用障碍（AUD）。部分的使命涉及临床前人类实验室研究，最终临床试验的翻译。2012年6月，根据合同HHSN 275200900005 C启动了NCIG 004研究，目的是评价新型化合物ABT-436，一种由AbbVie根据合作研发协议（CRADA）生产并提供给NIAAA的血管加压素1B拮抗剂。然而，该研究无法最终确定，将根据本任务指令进行过渡和完成。二.范围本任务指令旨在继续完成与NCIG 004研究相关的任务。

Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone. Thus, the search for new molecular targets and more efficacious drugs is critical. The creation of the NIAAA Clinical Investigations Group (NCIG) program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7-8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct Proof-of-Concept (POC) trials of promising compounds to treat alcohol dependence. To carry out this mission, a contract mechanism was authorized to fund the NCIG program, which includes a Data Coordinating Center and a network of experienced clinical trial sites. The NIAAA has a mission to develop safe and effective medications to treat alcohol use disorder (AUD) in various populations. Part of the mission involves translation of the preclinical to human laboratory studies to ultimately clinical trials. In June 2012, the NCIG 004 study was initiated under contract HHSN275200900005C for the purpose of evaluating the novel compound ABT-436, a vasopresson 1B antagonist manufactured and provided to NIAAA by AbbVie under a Cooperative Research and Development Agreement (CRADA). However, the study could not be finalized and it will be transitioned and completed under this Task Order. II. SCOPE The purpose of this Task Order is to continue the tasks associated with the completion of the NCIG 004 study.