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

酒精使用障碍（AUD）中味觉和嗅觉的个体差异

• 批准号: 10929790
• 负责人: Paule Joseph
• 金额: $ 40.06万
• 依托单位: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10929790
• 关键词: Affect; Alcohol abuse; Alcohol consumption; Alcohols; Area; Behavior; Biological; Biological Markers; Blood; Clinic; Collaborations; Data Collection; Development; Enrollment; Equipment and Supplies; Esthesia; Future; Genotype; Hour; Human; Impairment; Individual; Inflammation; Institutional Review Boards; Measures; Metabolic hormone; National Institute on Alcohol Abuse and Alcoholism; Natural History; Neurons; Nose; Participant; Perception; Phenotype; Public Health; Reporting; Research; Risk Factors; Saliva; Salivary; Sampling; Sensory; Series; Shapes; Signal Transduction; Smell Perception; System; Taste Perception; Testing; Texture; Training; United States National Institutes of Health; Variant; Visit; alcohol use disorder; chronic alcohol ingestion; clinical center; comorbidity; design; disorder risk; exosome; experience; falls; gut microbiota; improved; individual variation; inflammatory marker; innovation; microbiome composition; microbiota; operation; oral microbiome; prevent; primary endpoint; recruit; screening; secondary endpoint; sensory system; tool

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.

这项机构审查委员会批准的研究比较了有和没有AUD的个体之间的味觉和嗅觉测量以及酒精摄入量测量。该研究计划招募264名患有AUD的个体和132名没有AUD的个体。招生计划于2023年秋季开放。研究团队一直在努力完成3个关键领域的工作，以期招募第一名研究参与者，这些领域是制定临床操作和SOP，设计数据收集工具和系统，并准备好研究用品和设备。所有运营和监管方面的考虑，包括员工培训，都在进行中。此外，研究小组一直在通过与NIH以外的第三方招聘专家合作制定招聘和保留计划。因此，设计了创新和更有效的征聘和预选办法，并将在今后1-2个月内进行试验。 本研究将在NIH临床中心进行，预计将在招募开始后60个月内完成。本研究包括1次筛选访视和2次研究访视。将根据NIAAA自然史研究14-AA-0181对个体进行筛选。访视1和2将持续约4-6小时。