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

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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.