Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder

阿片类药物使用障碍虚拟认知情感训练的数字治疗开发

• 批准号: 10676262
• 负责人: RISA B WEISBERG
• 金额: $ 77.51万
• 依托单位: BEHAVR, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-15 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10676262
• 关键词: Abstinence; Adherence; Affect; Affective; American; Area Under Curve; Back; Behavior Therapy; Behavioral; Biochemical; Biometry; Brain; Buprenorphine; COVID-19 pandemic; Clinic; Clinical; Clinical Research; Cloud Computing; Cognitive; Computerized Medical Record; Data; Development; Dropout; Drug Modulation; Ecological momentary assessment; Educational Intervention; Electronic Health Record; Environment; Epidemic; Fast Healthcare Interoperability Resources; Feedback; Funding; Goals; Health Services Accessibility; Human; Human Resources; Individual; Ingestion; Intervention; Light; Link; Machine Learning; Measures; Medical Device; National Institute of Drug Abuse; Opioid; Outcome; Outcome Measure; Participant; Patients; Persons; Pharmaceutical Preparations; Phase; Process; Protocols documentation; Psychophysiology; Randomized, Controlled Trials; Records; Recovery; Regulatory Pathway; Relapse; Research Design; Resources; Rewards; Risk; Safety; Self Efficacy; Services; Signal Transduction; Small Business Innovation Research Grant; Specific qualifier value; Sum; System; Techniques; Teleconferences; Testing; Therapeutic Effect; Training; Translating; Treatment outcome; United States; United States Food and Drug Administration; Viral; addiction; affective neuroscience; arm; barrier to care; biobehavior; chronic pain; clinical efficacy; commercialization; craving; cue reactivity; design; digital treatment; effective intervention; efficacy study; electronic data; evidence base; experience; implementation barriers; improved; innovation; medication for opioid use disorder; meetings; mindfulness; neurophysiology; novel; opioid epidemic; opioid misuse; opioid treatment program; opioid use; opioid use disorder; patient engagement; patient safety; phase 1 study; pilot test; programs; promoter; prototype; relapse prevention; remediation; response; reward processing; satisfaction; skills; success; therapeutic development; therapy development; treatment as usual; treatment program; treatment risk; treatment strategy; usability; virtual; virtual machine; virtual reality; virtual reality system

Project Summary: The US is experiencing an opioid crisis, with an estimated 2.5 million Americans meeting full criteria for opioid use disorder (OUD). Medications for opioid use disorder (MOUD) like buprenorphine are currently the most effective form of intervention for OUD. In spite of the proven efficacy of MOUD, nearly half of people who begin a MOUD relapse within six months. As such, novel and efficacious behavioral adjuncts to MOUD are needed to improve treatment outcomes. Mindfulness-Oriented Recovery Enhancement (MORE), a cognitive-affective training intervention generated through a NIDA-funded treatment development process has shown significant promise, demonstrating therapeutic effects in four randomized controlled trials (RCTs) by reducing opioid use and misuse and modulating neurophysiological responses during drug cue-reactivity and natural reward processing. However, the MORE intervention requires significant human interaction and is therefore resource intensive. Further, in light of the COVID-19 pandemic, people with OUD may be reticent to engage in face-to-face interventions due to the risk of viral spread. To overcome these implementation barriers and increase access to treatment, the proposed project will develop and test a virtual reality version of the MORE intervention (MORE-VR) built on BehaVR LLC's VR existing, commercially available platform, the Dynamic eXperience Engine (DXE). The DXE uses machine learning to integrate biometrics into the VR experience to personalize addictions treatment, boosting patient engagement and optimizing the efficacy of clinical intervention. In Phase I, we will develop and test the MORE-VR prototype in a single arm clinical study of OUD patients receiving buprenorphine in an opioid treatment program (OTP), focusing on patient safety and engagement. If the prototype is perceived to have adequate usability and Net Promoter Scores, as well as to produce improvements in proximal measures of craving and affective state, the project will progress to Phase II. In Phase II, we will first develop the MORE-VR Minimal Viable Program using feedback from our Phase I study to optimize the intervention, and then conduct a RCT of MORE-VR vs. MOUD treatment as usual. Our robust and unbiased research design will triangulate clinical outcome measurement with biochemical verification of abstinence, ecological momentary assessments (EMA), and neurophysiological assessment of cue-reactivity. Further, we will integrate the MORE-VR Program into the OTP operational environment, building Fast Healthcare Interoperability Resources interfaces to ingest patient data from electronic medical records (EMRs) and to export patient utilization, assessment, and biometric data back to EMRs to create patient records and inform clinicians of patient progress. Activities in Phase I and Phase II will help define the regulatory pathway and establish regulatory feasibility to precede Food and Drug Administration (FDA) approval of the MORE-VR system as a Class II medical device. In sum, this project will translate an evidence- based biobehavioral treatment approach into an innovative digital therapeutic for OUD.

项目摘要：美国正在遇到阿片类药物危机，估计有250万美国人会议 阿片类药物使用障碍（OUD）的完整标准。阿片类药物使用障碍（MOUD）等药物等药物如丁丙诺啡 目前是OUD干预的最有效形式。尽管穆德有证实的功效，但几乎一半 在六个月内开始穆德复发的人。因此，新颖有效的行为辅助 需要moud来改善治疗结果。面向正念的恢复增强（更多） 通过NIDA资助的治疗发展过程产生的认知影响训练干预措施已有 显示出巨大的希望，证明了四个随机对照试验（RCT）的治疗作用 在药物提示反应性和 自然奖励处理。但是，干预措施越多需要大量的人类互动，是 因此资源密集型。此外，鉴于199年的大流行，OUD的人可能是沉默寡言的 由于病毒蔓延的风险，进行面对面的干预措施。克服这些实施障碍 并增加获得治疗的机会，拟议的项目将开发和测试虚拟现实版本 更多的干预措施（More-VR）建立在capary llc的VR现有，市售平台上， 动态体验引擎（DXE）。 DXE使用机器学习将生物识别技术集成到VR中 个性化成瘾治疗的经验，提高患者参与度并优化 临床干预。在第一阶段，我们将在单臂临床研究中开发和测试More-VR原型 在阿片类药物治疗计划（OTP）中接受丁丙诺啡的OUD患者，重点是患者安全和 订婚。如果认为原型具有足够的可用性和净启动子得分，以及 在渴望和情感状态的近端度量中产生改善，该项目将发展为阶段 ii。在第二阶段中，我们将使用I阶段I的反馈来开发更多的VR最小可行程序 研究以优化干预措施，然后像往常一样进行More-VR与MOUD治疗的RCT。我们的 强大而公正的研究设计将使用生化进行三角测量测量 验证禁欲，生态瞬时评估（EMA）和神经生理学评估 提示反应性。此外，我们将将More-VR计划集成到OTP操作环境中，建立 快速医疗保健互操作性资源将电子病历摄入患者数据界定 （EMR）并将患者利用，评估和生物识别数据出口到EMR中以创建患者 记录并告知临床医生患者的进度。第一阶段和第二阶段的活动将有助于定义 监管途径并在食品和药物管理局（FDA）之前建立监管可行性（FDA） 批准More-VR系统作为II类医疗设备。总而言之，该项目将转化一个证据 - 基于生物行为治疗方法，用于用于OUD的创新数字治疗。