NIAAA Clinical Trials

NIAAA 临床试验

• 批准号: 8948534
• 负责人: JANET RANSOM
• 金额: $ 339.38万
• 依托单位: FAST-TRACK DRUGS AND BIOLOGICS, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-23 至 2016-03-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8948534
• 关键词: Accountability; Adult; Advertising; Agreement; Alcohol dependence; Alcohols; Amendment; Annual Reports; Authorization documentation; Award; Biological; Blood; Blood specimen; Budgets; Calibration; Case Report Form; Certificate of Confidentiality; Clinic; Clinical; Clinical Data; Clinical Practice Guideline; Clinical Trials; Clinical Trials Data Monitoring Committees; Code; Collaborations; Collection; Computer software; Confidentiality; Conflict (Psychology); Conflict of Interest; Consent; Consent Forms; Contractor; Contracts; Data; Data Collection; Data Coordinating Center; Data Sources; Development; Dictionary; Disclosure; Documentation; Dose; Educational Curriculum; Electronics; Enrollment; Ensure; Epilepsy; Equipment; Ethnic Origin; Event; Exclusion Criteria; Extramural Activities; Financial Disclosures; Freezing; Funding; Generic Drugs; Good Clinical Practice; Grant; Guidelines; Health; Human; Human Resources; Hydrolysis; Individual; Industry; Information Systems; Informed Consent; Institutional Review Boards; Instruction; Internet; Job Description; Label; Laboratories; Laboratory Study; Libraries; Licensing; Location; Logistics; Manuals; Manufacturer Name; Medical; Mission; Molecular Target; Monitor; Names; National Institute on Alcohol Abuse and Alcoholism; Needles; Outcome Assessment; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Physicians; Placebo Control; Plasma; Population; Positioning Attribute; Postherpetic neuralgia; Preclinical Drug Evaluation; Preparation; Principal Investigator; Printing; Procedures; Process; Prodrugs; Protocols documentation; Quality Control; Questionnaires; Race; Radio; Randomized; Reading; Records; Recruitment Activity; Reporting; Research Personnel; Resolution; Restless Legs Syndrome; Rights; Safety; Sample Size; Sampling; Schedule; Secure; Security; Selection Criteria; Serious Adverse Event; Services; Shipping; Ships; Site; Slide; Specimen; Study Subject; Substance abuse problem; Syringes; System; Tablets; Teleconferences; Telephone; Testing; Time; Training; Translations; Tube; United States Food and Drug Administration; Update; Urine; Visit; Withdrawal; Work; absorption; alcohol use disorder; analog; base; clinical research site; cost; data exchange; data management; design; drug distribution; electronic data; experience; gabapentin; gamma-Aminobutyric Acid; meetings; member; operation; payment; phosphatidylethanol; pre-clinical; programs; protocol violation; quality assurance; response; sample collection; screening; statistics; symposium

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.

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。加巴喷丁是一种GABA类似物，最初开发用于治疗癫痫（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Enacarbil是加巴喷丁的主动转运前药，其在吸收后快速水解为加巴喷丁，旨在产生剂量比例的加巴喷丁血液水平暴露。加巴喷丁enacarbil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。二.范围本任务指令的目的是为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enacarbil治疗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对至少50例受试者进行启动活动、随机化和研究实施。