A Novel Human Laboratory Model for Screening Medications for Alcohol Use Disorder

用于筛选酒精使用障碍药物的新型人体实验室模型

基本信息

批准号：
10387543
负责人：
LARA A. RAY
金额：
$ 4.68万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-10 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10387543
关键词：
Administrative Supplement Advisory Committees Alcohol consumption Alcohols Area COVID-19 COVID-19 pandemic Clinical Clinical Research Clinical Trials Cross-Over Studies Crossover Design Cues DSM-V Detection Development Disease Double-Blind Method FDA approved Human Individual Laboratories Laboratory Study Literature Medication Management Methods Modeling Naltrexone Outcome Participant Persons Pharmaceutical Preparations Pharmacotherapy Phase Placebos Procedures Process Protocols documentation Randomized Reading Recovery Reporting Research Priority Resources Safety Self Administration Signal Transduction Telephone Testing Time Translations Treatment Efficacy United States Woman alcohol craving alcohol cue alcohol response alcohol screening alcohol use disorder base breath alcohol measurement clinically relevant cost cue reactivity drinking drinking behavior improved intrinsic motivation medication compliance men novel novel strategies pandemic disease phase 2 study phase 2 testing primary outcome recruit response screening smoking cessation

项目摘要

ABSTRACT This administrative supplement application is intended to support the timely and full completion of the proposed study and to offset delays caused by the COVID-19 Pandemic. As detailed in the application, 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 administrative supplement, we carefully justify the request for additional resources to effectively complete the original project and mitigate COVID-19 delays in recruitment. 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 19 randomizations during a full year of COVID-19 disruption. Further, we have kept the protocol integrity and have conducted daily telephone and zoom-based sessions, which enable close contact between participants and study staff. 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 of study participation. This administrative supplement will provide much-needed support a high-fidelity protocol that has been kept intact and operational despite substantial challenges associated with the pandemic.

抽象的本行政补充申请旨在支持及时、全面完成拟议的研究并抵消因 COVID-19 大流行造成的延误。正如申请中详细说明的那样，我们已经处理了一系列与 COVID-19 相关的延误，同时还保持了实验室的开放和在加州大学洛杉矶分校 (UCLA) COVID-19 应对措施允许的最大程度上进行持续招聘，并且恢复工作组。在本行政补充文件中，我们仔细证明了额外要求的合理性有效完成原始项目并减少因 COVID-19 造成的招聘延误的资源。尽管面临新冠肺炎 (COVID-19) 大流行的挑战，我们的团队仍然坚韧且勤奋。我们尽我们所能地维持招募工作，并在期间完成了 19 次随机分组 COVID-19 扰乱了全年。此外，我们保持了协议的完整性并每天进行基于电话和变焦的会议，使参与者和研究人员之间能够密切联系。这使我们能够与拟议的方案保持一致，提供谨慎的药物治疗管理，验证药物合规性，并获得所有必要的临床安全实验室学习参与的开始。该行政补充文件将提供急需的支持尽管面临巨大的挑战，高保真协议仍保持完整并可运行随着大流行。