Biomarkers for Opioid Use Disorder (OUD)

阿片类药物使用障碍 (OUD) 的生物标志物

• 批准号: 10740639
• 负责人: Laura Dipietro
• 金额: $ 32万
• 依托单位: HIGHLAND INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10740639
• 关键词: Address; Age; Algorithms; Authorization documentation; Biological Markers; Brain; Cessation of life; Characteristics; Classification; Clinical; Clinical Data; Clinical Markers; Clinical Research; Confidential Information; Control Groups; Cues; Data; Development; Diagnosis; Diagnostic; Disease; Drug usage; Electroencephalography; Enrollment; Feasibility Studies; Foundations; Frequencies; Funding; Grant; Hair; Health; Impulsivity; Intervention; Linear Models; Maps; Marketing; Measures; Medical; Medical Device; Methodology; Monitor; Moods; National Institute of Drug Abuse; Nature; Obsessive compulsive behavior; Opiate Addiction; Opioid; Overdose; Patients; Performance; Phase; Prediction of Response to Therapy; Prognosis; Questionnaires; Research; Resources; Rest; Rights; Scalp structure; Small Business Innovation Research Grant; Source; Techniques; Testing; Time; Toxicology; United States National Institutes of Health; Urine; Work; addiction; biomarker identification; candidate identification; candidate marker; cohort; commercialization; cost; craving; density; diagnostic value; fighting; human subject; illness length; instrument; methadone treatment; neuroimaging; noninvasive brain stimulation; opioid epidemic; opioid use disorder; pharmacologic; phase 2 study; polysubstance use; power analysis; predicting response; prognostic; prognostic value; psychosocial; reconstruction; research clinical testing; response; screening; side effect; tool development; treatment response

Proprietary: This proposal includes trade secrets and other proprietary or confidential information of Highland Instruments and is being provided for use by the National Institutes of Health (NIH) for the sole purpose of evaluating this SBIR proposal. No other rights are conferred. This proposal and the trade secrets and other proprietary or confidential information contained herein shal further not be disclosed in whole or in parts, outside of NIH without Highland Instrument's permission. This restriction does not limit the NIH's right to use information contained in the data if it is obtained from another source without restriction. This legend applies to the Abstract, Specific Aims, Research Plan (al components), Commercialization Plan, and Human Subject's Sections of this proposal. Abstract The U.S. is suffering from a national opioid epidemic characterized by significant costs, overdoses, and deaths. OUD is diagnosed using qualitative criteria (i.e., clinical scales and questionnaires (e.g., DMSV criteria)), and toxicology screening with various degrees of testing accuracy. Biomarkers for OUD with diagnostic and prognostic value represent an unmet need that has been recognized by NIDA and the FDA. Conventional OUD treatments (i.e., pharmacological and psychosocial interventions) are characterized by limited or diminishing efficacy, ceiling effects, and/or serious side effects. The availability of validated OUD biomarkers would be a key step in the development and approval of better treatments. Ultimately, the scarcity of OUD biomarkers represents a significant unmet need in the fight against opioid addiction as recognized by NIDA and the FDA with their support for development of Medical Device Development Tools (MDDT) and biomarker tests for OUD. Advances in neuroimaging techniques, and in particular recent evidence supports electroencephalography (EEG) as a very promising candidate to investigate the correlation between addiction and brain state. Building on EEG data gathered during our OUD clinical study aimed at developing a new medical device for OUD treatment, we propose to explore the use of high-density electroencephalography (EEG) to identify candidate biomarkers for OUD for diagnosis, disease monitoring and prediction of OUD treatment response. We will enroll 50 OUD patients at various stages of treatment as well as 20 non-OUD healthy controls. For these subjects, we will gather current and historical drug use data, clinical data (including questionnaires on cravings and mood), and toxicology (hair, urine). Next, we will record high-density EEG at rest and during a Craving/Cue Exposure task. EEG analysis will focus on power analysis, scalp maps, and source reconstruction. We will extract a battery of EEG-based measures and assess whether they are able to differentiate between clinical characteristics of the patients such as stability of treatment, cue exposure craving response, polysubstance use, and duration of disease. Finally, we will repeat the analysis in our historical data from OUD patients undergoing brain stimulation to determine if the EEG-based measures are responsive to brain stimulation treatment. Ultimately this project will aim at developing candidate EEG biomarkers which could potentially be used for OUD diagnosis, disease and treatment monitoring, and prediction of treatment response.

专有：该提案包括高地工具的商业秘密和其他专有或机密信息，并正在美国国立卫生研究院（NIH）提供使用该SBIR提案的唯一目的。没有其他权利获得。这个建议和 未经高地仪器的许可，在NIH之外，本文中包含的商业秘密和其他专有或机密信息均不得全部或部分披露。该限制并不限制NIH使用数据中包含的信息的权利，如果它是从数据中获得的 另一个无限制的来源。该传说适用于摘要，具体目的，研究计划（AL组件），商业化计划以及人类主题的该提案部分。 抽象的 美国正患有全国阿片类药物流行病，其特征是大量成本，过量服用和死亡。 使用定性标准（即临床量表和问卷（例如DMSV标准））和 具有不同测试准确性的毒理学筛查。诊断和 预后价值代表了NIDA和FDA认可的未满足需求。传统的Oud 治疗（即药理和社会心理干预措施）的特征是有限或减少 功效，天花板效应和/或严重的副作用。经过验证的OUD生物标志物的可用性将是关键 介入发展和批准更好的治疗方法。最终，Oud生物标志物的稀缺性代表 NIDA和FDA认可的与阿片类药物成瘾的斗争中的重要需求 支持开发医疗设备开发工具（MDDT）和OUD生物标志物测试。进步 在神经影像技术中，特别是最近的证据支持脑电图（EEG） 有希望的候选人研究成瘾与大脑状态之间的相关性。基于脑电图数据 我们在OUD临床研究中收集的旨在开发一种新的医疗设备以进行OUD治疗，我们 建议探索使用高密度脑电图（EEG）来识别候选生物标志物的使用 OUD用于诊断，疾病监测和OUD治疗反应的预测。我们将注册50 Oud 患者处于治疗的各个阶段以及20个非饮食健康对照。对于这些主题，我们将聚集 当前和历史药物使用数据，临床数据（包括有关渴望和情绪的问卷）以及 毒理学（头发，尿液）。接下来，我们将在休息和渴望/提示曝光任务中记录高密度的脑电图。 脑电图分析将集中于功率分析，头皮图和源重建。我们将提取一电池 基于脑电图的措施并评估它们是否能够区分 诸如治疗稳定性，提示暴露的渴望反应，多物质使用以及持续时间之类的患者 疾病。最后，我们将在OUD患者的历史数据中重复进行大脑刺激的分析 确定基于脑电图的措施是否对大脑刺激治疗有反应。最终这个项目 旨在开发候选脑电图生物标志物，可能用于OUD诊断，疾病 和治疗监测以及治疗反应的预测。