NIAAA Clinical Trials

药物开发是国家酒精滥用和酒精中毒研究所（NIAAA）的一个优先项目。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显示出小到中等的效果，并不是对每个人都有效。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）项目的创建是由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日建议的，随后由NIAAA全国咨询委员会于2005年6月批准。理事会认识到迫切需要建立一个快速和有效的机制，对治疗酒精依赖的有希望的化合物进行概念验证试验。为了完成这一任务，授权了一个合同机制来资助NCIG项目，其中包括一个数据协调中心和一个经验丰富的临床试验点网络。NIAAA的使命是开发安全有效的药物来治疗不同人群的酒精使用障碍（AUD）。任务的一部分包括将临床前研究转化为人体实验室研究，最终转化为临床试验。加巴喷丁是一种GABA类似物，最初用于治疗癫痫（Neurontin®），最近已被批准用于治疗带状疱疹后神经痛（Neurontin®，Gralise®）。加巴喷丁那沙比尔是一种主动转运的加巴喷丁前药，吸收后快速水解为加巴喷丁，设计用于产生剂量成比例的加巴喷丁血水平暴露。加巴喷丁那沙比尔缓释片（Horizant®）被批准用于治疗成人中度至重度原发性不宁腿综合征和成人带状疱疹后神经痛。2。本任务订单的目的是为NCIG 006研究进行研究材料的规划和准备，该研究涉及在加巴喷丁那沙比尔用于酒精使用障碍患者的随机安慰剂对照概念验证临床试验中进行至少50名受试者的启动活动、随机化和研究。

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. Gabapentin is a GABA analog that was originally developed to treat epilepsy (Neurontin®) and more recently has been approved for the treatment of postherpetic neuralgia (Neurontin®, Gralise®). Gabapentin enacarbil is an actively transported prodrug of gabapentin that undergoes rapid post absorption hydrolysis to gabapentin that was designed to produce dose proportional gabapentin blood level exposure. Gabapentin enacarbil Extended Release Tablets (Horizant®) is approved for the treatment of moderate to severe primary restless leg syndrome in adults and management of postherpetic neuralgia in adults. II. SCOPE The purpose of this task order is to perform the planning and preparation of study materials for the NCIG 006 study which involves conducting start-up activities, randomization and study conduct for at least 50 subjects in a randomized placebo controlled proof-of-concept clinical trial of gabapentin enacarbil for patients with alcohol use disorder.