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.

抽象的此行政补充申请旨在支持及时和完整完成拟议的研究和抵消了由19009大流行引起的延迟。如应用程序中详细介绍的我们已经处理了许多COVID-19相关延迟，同时还保持实验室公开和在UCLA COVID-19响应中允许的最高程度进行持续招聘，并恢复工作队。在此行政补充中，我们仔细证明请求额外的请求资源有效地完成原始项目并减轻招聘中的Covid-19延迟。尽管Covid-19的大流行面临挑战，但我们的团队仍然具有韧性和努力。我们在我们的能力上保持了招聘工作，并在共同的2019年中断一年。此外，我们保持了协议的完整性并每天进行基于电话和缩放的会议，可以在参与者和学习人员之间进行密切联系。这使我们能够在拟议的协议上保持一致，提供仔细的药物治疗管理，验证药物合规性并获得所有必要的临床安全实验室开始研究的开始。这种行政补充剂将提供急需的支持尽管存在重大挑战，但仍保持完整和运营的高保真协议大流行。