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

开发用于药物测试研究的移动酒精生物传感器平台

• 批准号: 10388196
• 负责人: Walter McRainey Roberts
• 金额: $ 16.53万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-20 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10388196
• 关键词: Acute; Alcohol consumption; Alcoholic beverage heavy drinker; Alcohols; Algorithms; Area; Behavior; Behavior assessment; Bioethics; Biosensor; Blood alcohol level measurement; Cellular Phone; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Data; Data Analyses; Data Science; Detection; Development; Dose; Drug Kinetics; Economics; Educational workshop; Environment; Event; Foundational Skills; Gestures; Goals; Grant; Health; Human; Intoxication; Intramural Research Program; Laboratories; Laboratory Study; Lead; Machine Learning; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methods; Motion; National Institute on Alcohol Abuse and Alcoholism; Outpatients; Participant; Performance; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Play; Preclinical Testing; Psychiatry; Psychopharmacology; Public Health; Research; Research Methodology; Research Personnel; Research Project Grants; Resources; Role; Safety; Sampling; Scientist; Statistical Methods; Technology; Testing; Time; Training; Training Activity; United States; Universities; Work; Wrist; Writing; alcohol availability; alcohol effect; alcohol measurement; alcohol screening; alcohol use disorder; base; career; cognitive control; cognitive function; craving; design; detection test; disabling disease; drinking; experience; experimental study; innovation; interest; laboratory experiment; mHealth; professor; programs; research and development; screening; sensor; smart watch; statistics; substance use; symposium; training opportunity; treatment research; wearable sensor technology; wireless

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.

项目摘要/摘要 这项受到指导的以患者为导向的研究职业发展奖（K23）将使罗伯茨博士能够实现 他成为一名努力发展的独立临床研究人员的长期职业目标 酒精使用障碍的药物治疗（AUD）。该提案概述了一项为期5年的培训计划，该计划支持 一项研究计划旨在开发移动生物传感器平台，以跟踪药物对药物的影响 在门诊患者中酒精反应性。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）AUD药物疗法开发 研究。培训计划包括由导师领导的培训的战略组合；手机课程 健康传感，数据科学，统计，生物伦理学，临床研究方法和赠款写作；出席 相关会议和讲习班；并与在AUD进行研究的调查人员合作 药物疗法开发。候选人将完成这些培训活动，同时完成 研究计划旨在开发一个可以被动跟踪酒精的移动生物传感器平台 饮酒发作期间，要在关键点进行有条件评估。在这些初步 研究，aud饮酒的大量饮酒者将佩戴移动生物传感器并在实验室接受酒精。在 实验1，参与者在佩戴生物传感器并做出反应时将获得两次固定剂量的酒精 提示评估。该实验的目标将是1）完善机器学习派生检测 算法将在饮酒期间识别要点，以及2）评估用户体验和 在饮酒情节期间，在智能手机上进行促使评估的可行性。实验2将 在单独的自由行为参与者的样本中测试检测算法 饮酒。这些研究的结果将作为试点数据，以支持R-Mechanism的应用 使用生物传感器平台开发正式范式，以跟踪酒精使用的药物影响和 卧床门诊患者的反应性。罗伯茨博士已经组建了一个领导人的指导委员会 场地。 McKee博士（主要导师）是耶鲁大学精神病学教授。她申请了创新 实验室范例是AUD药物疗法开发研究，她有多项研究 使用移动健康生物传感器跟踪药物使用行为。 Ramchandani博士（主要院）是 NIAAA壁内研究的临床研究者和人类心理药理学部门负责人 程序。他将领导罗伯茨博士在酒精药代动力学方面的培训。博士。 Gueorguieva，Petrakis和 Gerstein将担任次要导师，并为Roberts博士在纵向数据分析中的培训做出贡献， AUD药物治疗临床试验以及机器学习和数据科学。博士。米兰达和 巴内特将担任外部顾问，并支持罗伯茨博士在卧床评估中的培训 药物开发研究和透皮酒精检测的背景。