Developing a mobile alcohol biosensor platform for use in medication testing research

项目摘要/摘要 这项以患者为导向的导师研究职业发展奖(K23)将使罗伯茨博士能够实现 他的长期职业目标是成为一名独立的临床研究员，致力于开发 酒精使用障碍的药物治疗(AUD)。这份提案概述了一项为期5年的培训计划，以支持 一项专注于开发移动生物传感器平台的研究计划，用于跟踪药物对 门诊患者的酒精反应。培训领域包括1)移动生物传感器评估 酒精使用，2)生物传感器数据的管理和分析，以及3)药物治疗的发展 研究。培训计划包括由导师指导的培训的战略组合；移动课程 健康感应、数据科学、统计学、生物伦理学、临床研究方法和拨款撰写；出席 相关会议和讲习班；与在澳元进行研究的调查人员合作 药物治疗的发展。应聘者将完成这些培训活动，同时完成 旨在开发可被动跟踪酒精的移动生物传感器平台的研究计划 并在饮酒期间的关键点进行有条件的评估。在这些初步报告中 研究表明，患有澳门氏症的酗酒者将佩戴移动生物传感器，并在实验室接受酒精。在……里面 实验一，参与者将在佩戴生物传感器的同时接受两种固定剂量的酒精并做出反应 到提示性评估。本实验的目标将是1)改进机器学习派生检测 算法将识别饮酒过程中的关键点，并2)评估用户体验和 在饮酒期间，在智能手机上提供提示评估的可行性。实验2将 在自由行为参与者的单独样本中测试检测算法，这些参与者从事自定进度 酗酒。这些研究的结果将作为试点数据，支持R机制应用于 使用生物传感器平台开发一个正式的范例，以跟踪酒精使用和 门诊就诊患者的反应性。罗伯茨博士已经组建了一个领导指导委员会 菲尔德。麦基博士(主要导师)是耶鲁大学的精神病学教授。她运用创新的方法 实验室范型到AUD药物治疗开发研究，她有几个研究方向 使用移动健康生物传感器跟踪物质使用行为。Ramchandani博士(主要合作导师)是一位 NIAAA内部研究的临床调查员和人类精神药理科科长 程序。他将领导罗伯茨博士在酒精药物动力学方面的培训。Guorguieva博士、Petrakis博士和 格斯坦将担任二级导师，并为罗伯茨博士在纵向数据分析方面的培训做出贡献。 AUD药物治疗临床试验，以及机器学习和数据科学。米兰达博士和 巴尼特将担任外部顾问，并支持罗伯茨博士在 药物开发研究和经皮酒精检测的背景。

PROJECT SUMMARY/ABSTRACT This mentored patient-oriented research career development award (K23) will enable Dr. Roberts to achieve his long-term career goal of becoming an independent clinical researcher working to develop pharmacotherapies for alcohol use disorder (AUD). This proposal outlines a 5-year training plan that supports a research program focused on developing a mobile biosensor platform for tracking medication effects on alcohol reactivity in ambulating outpatients. Training domains include 1) mobile biosensor assessment of alcohol use, 2) management and analysis of biosensor data, and 3) AUD pharmacotherapy development research. The training plan includes a strategic combination of mentor-led trainings; coursework in mobile health sensing, data science, statistics, bioethics, clinical research methods, and grant writing; attendance at relevant conferences and workshops; and collaboration with investigators conducting research in AUD pharmacotherapy development. The candidate will complete these training activities while completing a research program aimed at developing a mobile biosensor platform that can passively track alcohol consumption and deliver conditional assessments at key points during drinking episodes. In these preliminary studies, heavy drinkers with AUD will wear the mobile biosensors and receive alcohol in the laboratory. In Experiment 1, participants will receive two fixed doses of alcohol while wearing the biosensors and responding to prompted assessments. Goals of this experiment will be to 1) refine the machine-learning derived detection algorithms that will identify key points during drinking episodes and 2) evaluate the user experience and feasibility of delivering prompted assessments on a smartphone during drinking episodes. Experiment 2 will test the detection algorithms in a separate sample of freely behaving participants engaged in self-paced alcohol drinking. Results of these studies will serve as pilot data to support an R-mechanism application to develop a formal paradigm using the biosensor platform to track medication effects of alcohol use and reactivity in ambulating outpatients. Dr. Roberts has assembled an mentorship committee of leaders in the field. Dr. McKee (primary mentor) is a Professor of Psychiatry at the Yale University. She applies innovative laboratory paradigms to AUD pharmacotherapy development research, and she has several lines of research using mobile health biosensors to track substance use behavior. Dr. Ramchandani (primary co-mentor) is a clinical investigator and Chief of the Human Psychopharmacology Section at the NIAAA intramural research program. He will lead Dr. Roberts's training in alcohol pharmacokinetics. Drs. Gueorguieva, Petrakis, and Gerstein will serve as secondary mentors and contribute to Dr. Roberts's training in longitudinal data analysis, AUD pharmacotherapy clinical trials, and machine learning and data science, respectively. Drs. Miranda and Barnett will serve as external advisers and support Dr. Roberts's training in ambulatory assessment in the context of medication development research and transdermal alcohol detection, respectively.