A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder

神经免疫调节剂异丁司特治疗酒精使用障碍的随机对照临床试验

• 批准号: 10387454
• 负责人: LARA A. RAY
• 金额: $ 15.44万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-08 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10387454
• 关键词: Administrative Supplement; Advisory Committees; Alcohol consumption; Alcohols; Attenuated; Behavioral; Blood; Brain; COVID-19; COVID-19 pandemic; Chronic; Clinical; Contracts; Cues; Data; Development; Dose; Double-Blind Method; Genes; Heavy Drinking; Human; Individual; Inflammatory; Knock-out; Laboratories; Laboratory Study; Lipopolysaccharides; Maintenance; Measures; Medication Management; Migration Inhibitory Factor; Molecular Target; Moods; National Institute on Alcohol Abuse and Alcoholism; Neuroimmune; Online Systems; Outpatients; Participant; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Placebos; Process; Protocols documentation; Randomized; Randomized Controlled Clinical Trials; Recovery; Relapse; Research; Research Priority; Resources; Rodent; SARS-CoV-2 infection; Safety; Self Administration; Signal Transduction; Standardization; Stress; Telephone; Testing; Time; Universities; Visit; Woman; addiction; alcohol abuse therapy; alcohol craving; alcohol cue; alcohol effect; alcohol measurement; alcohol response; alcohol seeking behavior; alcohol use disorder; base; chronic alcohol ingestion; craving; cytokine; depressive symptoms; drinking; efficacy testing; follow-up; improved; indexing; medication administration; medication compliance; men; multi-site trial; negative mood; neuroinflammation; neuron loss; neurotoxic; neurotrophic factor; novel; phosphodiesterase IV; positive mood; pre-clinical; preclinical safety; preference; primary endpoint; programs; randomized placebo-controlled clinical trial; recruit; response; safety testing; secondary endpoint; symptomatology; week trial

ABSTRACT This administrative supplement application is intended to support the timely and full completion of the originally proposed study and to offset delays caused by the COVID-19 Pandemic. As detailed in this supplement, we have dealt with a host of COVID-19 related delays, while also maintaining the laboratory open and conducting ongoing recruitment to the maximum degree allowed by the UCLA COVID-19 Response and Recovery Task Force. In this supplement application we provide details that justify the request for additional resources to effectively complete the original project and to mitigate COVID-19 delays in recruitment. We note that a systematic process of evaluating the forced closures (either by the University or as a result of staff contracting and managing COVID-19 infection) and their impact on recruitment was undertaken in order to reach a sensible and data-informed budgetary request. Despite the challenges of the COVID-19 pandemic our team has been resilient and hard-working. We have maintained recruitment efforts to the best of our ability and completed 24 randomizations during a full year of COVID-19 disruption. This is a testament to our commitment to this research. Notably, we have kept the protocol integrity and have only conducted a minimum of telephone and zoom-based follow-up sessions. This allowed us to stay consistent with regard to the proposed protocol, provide careful medication management, verify medication compliance, and obtain all necessary clinical safety labs at the beginning and the end of study participation. This administrative supplement application will support the timely and full completion of the originally proposed study.

摘要 此行政补充申请旨在支持及时和全面完成 该计划旨在减少最初提出的研究，并抵消COVID-19大流行造成的延误。正如这份 作为补充，我们已经处理了一系列与COVID-19相关的延迟，同时还维护了实验室 在加州大学洛杉矶分校COVID-19允许的最大程度上公开并持续进行招聘 响应和恢复工作队。在本补充申请中，我们提供了证明 要求提供额外资源，以有效完成原有项目并缓解COVID-19 招聘延迟。我们注意到，评估强制关闭的系统进程（无论是由 大学或因员工感染和管理COVID-19感染而导致的影响）及其对 进行招聘是为了达到合理且基于数据的预算要求。尽管 面对COVID-19疫情的挑战，我们的团队一直保持坚韧和勤奋。我们有 尽我们最大的能力维持招募工作，并在一整年内完成了24次随机化 COVID-19中断。这证明了我们对这项研究的承诺。值得注意的是， 方案完整性，并且仅进行了最少的电话和基于缩放的随访 sessions.这使我们能够在拟议的协议方面保持一致， 药物管理，验证药物依从性，并获得所有必要的临床安全实验室 参与研究的开始和结束。此管理补充应用程序将支持 及时和全面完成最初提出的研究。