权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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.

摘要这项行政补充申请旨在支持及时和全面完成拟议的研究，并抵消新冠肺炎大流行造成的延误。如申请书中所详细描述的，我们已经处理了一系列与新冠肺炎相关的延误，同时也保持了实验室的开放和在加州大学洛杉矶分校新冠肺炎回应和允许的最大程度上进行持续招聘恢复特遣部队。在这份行政副刊中，我们仔细地证明了要求增加有效完成原项目并缓解新冠肺炎招聘延迟的资源。尽管面临着新冠肺炎疫情的挑战，但我们的团队坚韧不拔，勤奋工作。我们尽我们所能地保持招聘工作，并在一年中完成了19次随机新冠肺炎中断的一整年。此外，我们保持了协议的完整性，并每天进行电话和基于缩放的会议，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，提供仔细的药物治疗管理，验证用药依从性，并获得所有必要的临床安全实验室开始参与学习。这一行政副刊将提供急需的支持高保真协议，尽管存在重大挑战，但仍保持完好并可正常运行随着大流行的到来。