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

摘要 这项行政补充申请旨在支持及时和全面完成 最初提议进行研究，以抵消新冠肺炎大流行造成的延误。如本文件中所述 作为补充，我们已经处理了一系列与新冠肺炎相关的延误，同时也维持了实验室 在加州大学洛杉矶分校新冠肺炎允许的最大程度上公开并持续进行招聘 响应和恢复特遣部队。在本补充申请中，我们提供了详细信息，证明 请求额外资源以有效完成原始项目并缓解新冠肺炎 招聘方面的拖延。我们注意到，评估强制关闭的系统进程(通过 大学或因员工感染新冠肺炎而感染)及其影响 进行征聘是为了达成明智和了解数据的预算要求。尽管 面对新冠肺炎疫情的挑战，我们的团队坚韧不拔，勤奋工作。我们有 尽我们所能地保持招聘工作，并在一整年内完成了24次随机抽样 新冠肺炎的颠覆。这证明了我们对这项研究的承诺。值得注意的是，我们一直在保持 协议的完整性，并只进行了最低限度的电话和基于缩放的后续 会话。这使我们能够在拟议的议定书方面保持一致，提供谨慎的 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 学习参与的开始和结束。此行政补充应用程序将支持 及时和全面完成原先提议的研究。

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.