Individual Variations of Taste and Smell Perception in Alcohol Use Disorder (AUD)

这项机构审查委员会批准的研究比较了味觉和嗅觉指标以及酒精摄入量指标在患有和不患有AUD的个体之间的差异。这项研究计划招募264名患有澳门氏症的人和132名没有澳门氏症的人。招生计划于2023年秋季开始。研究小组一直在努力敲定3个关键领域，以期招募第一个研究参与者，这些领域是开发临床操作和SOP，设计数据收集工具和系统，以及准备研究用品和设备。所有业务和监管方面的考虑，包括工作人员培训，都在进行中。此外，研究小组通过与NIH以外的第三方招聘专家合作，一直在制定招聘和保留计划。因此，设计了新的、更有效的征聘和预选方法，并将在未来1-2个月内进行测试。 这项研究将在NIH临床中心进行，预计将在注册开始后的60个月内完成。这项研究包括一次筛查访问和两次研究访问。个人将根据NIAAA自然历史研究14-AA-0181进行筛查。参观1和2将持续大约4-6个小时。

This Institutional Review Board-approved study compares taste and smell measures and measures of alcohol intake between individuals with and without AUD. The study plans to enroll 264 individuals with AUD and 132 individuals without AUD. Enrollment is planned to open in fall 2023. The study team has been working on finalizing 3 key areas in anticipation of enrolling the first research participant, these are develop clinic operations and SOPs, design data collection tools and systems, and make study supplies and equipment ready. All operational and regulatory considerations, including staff training, are underway. Moreover, the study team has been working on recruitment and retention plans through collaborating with third party recruitment experts outside the NIH. Consequently, innovative, and more efficient ways of recruitment and prescreening have been designed and will be tested in the next 1-2 months. This study will take place at the NIH clinical Center and is expected to be completed in 60 months from opening of enrollment. The study involves one screening visit and 2 study visits. Individuals will be screened under the NIAAA Natural History study, 14-AA-0181. Visits 1 and 2 will last approximately 4-6 hours.