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

项目概要/摘要 这个指导以患者为导向的研究职业发展奖（K23）将使罗伯茨博士实现 他的长期职业目标是成为一名独立的临床研究人员， 酒精使用障碍（AUD）的药物治疗。该提案概述了一项5年培训计划， 一项研究计划，重点是开发一种移动的生物传感器平台，用于跟踪药物对 门诊病人的酒精反应。训练领域包括1）移动的生物传感器评估， 酒精使用，2）生物传感器数据的管理和分析，以及3）AUD药物疗法开发 research.培训计划包括导师主导的培训的战略组合;移动的 健康感知，数据科学，统计学，生物伦理学，临床研究方法和拨款写作;出席 相关会议和讲习班;以及与在澳大利亚进行研究的研究人员合作 药物治疗发展。候选人将在完成这些培训活动的同时完成 一项旨在开发一种可以被动跟踪酒精的移动的生物传感器平台的研究计划 在饮酒事件期间的关键点提供有条件的评估。在这些初步 在一项研究中，患有AUD的重度饮酒者将佩戴移动的生物传感器，并在实验室接受酒精。在 实验1，受试者将接受两个固定剂量的酒精，同时佩戴生物传感器并做出反应 进行评估。本实验的目标是：1）完善机器学习衍生的检测 将识别饮酒事件期间的关键点的算法，以及2）评估用户体验， 在饮酒事件期间在智能手机上提供提示评估的可行性。实验2将 在一个单独的样本中测试检测算法，这些样本是行为自由的参与者， 饮酒。这些研究的结果将作为试点数据，以支持R机制的应用， 使用生物传感器平台开发正式范例，以跟踪酒精使用的药物效应， 门诊病人的反应。罗伯茨博士已经召集了一个指导委员会的领导人在 领域麦基博士（主要导师）是耶鲁大学精神病学教授。她运用创新的 她是AUD药物治疗开发研究的实验室范例，她有几条研究路线 使用移动的健康生物传感器来跟踪物质使用行为。Ramchandani博士（主要共同导师）是一位 临床研究员和NIAAA内部研究的人类精神药理学部门负责人 程序.他将领导罗伯茨博士的酒精药代动力学培训。Gueorguieva博士Petrakis博士和 Gerstein将担任二级导师，并为Roberts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 巴内特将担任外部顾问，并支持罗伯茨博士在 分别用于药物开发研究和透皮酒精检测。

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.