Modular Virtual Reality Therapeutic for Opioid and Stimulant Use Disorders

针对阿片类药物和兴奋剂使用障碍的模块化虚拟现实治疗

• 批准号: 10784642
• 负责人: Michelle (Micki) E Washburn
• 金额: $ 32.65万
• 依托单位: INNATEVR, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10784642
• 关键词: Acute; Address; Aftercare; Behavioral; Businesses; Cardiovascular system; Cessation of life; Child Welfare; Chronic; Clinical; Clinical effectiveness; Cocaine; Complex; Computer software; Coping Skills; Criminal Justice; Cues; Data; Disease; Effectiveness; Emergency Care; Environment; Environment Design; Evidence based intervention; Exposure to; FDA approved; Feedback; Fentanyl; Goals; HIV/HCV; Harm Reduction; Health; Health Personnel; Heroin; Impairment; Individual; Infection; Ingestion; Intervention; Justice; Learning; Left; Libraries; Licensing; Mental Health; Methamphetamine; Methods; National Institute of Drug Abuse; Neonatal Abstinence Syndrome; Outcome; Outpatients; Overdose; Participant; Patients; Phase; Phase II Clinical Trials; Physiologic Monitoring; Premature Birth; Prevention; Protocols documentation; Public Health; Quality of life; Randomized; Recording of previous events; Recovery; Recovery Support; Recurrence; Relapse; Research; Risk; Running; Safety; Site; Small Business Innovation Research Grant; Social Environment; Social Interaction; Strategic Planning; Supervision; System; Testing; Translating; Update; Variant; Work; addiction; animation; behavioral health; cost; craving; demographics; design; digital treatment; effectiveness evaluation; effectiveness study; effectiveness trial; emotion regulation; habituation; health application; improved; in vivo; innovation; mortality; novel; opioid use; opioid use disorder; pharmacologic; phase 2 study; physical conditioning; real time monitoring; relapse prevention; relapse risk; return to use; simulation; social; stimulant misuse; stimulant use disorder; substance misuse; substance use; substance use treatment; therapeutic opioid; treatment organization; usability; virtual; virtual environment; virtual reality

PROJECT SUMMARY Opioid and/or Stimulant Use Disorders (OUD/StUD) are chronic, recurring conditions that if left untreated, pose a significant and ongoing public health and safety threat, with costs associated with OUD alone in the US exceeding one trillion dollars annually. Virtual Reality Cue Exposure (VRCE) employs safe and controlled repeated exposure to a variety of substance use cues and environments designed to induce craving within the virtual space. This can be done in a way that is not feasible “in vivo” due to health and safety concerns, filling a persistent gap in current treatment approaches for the non-pharmacological treatment of OUD/StUD. While in the virtual environment, the patient will habituate to the substance use cues and work with a therapist to learn coping skills for tolerating craving while not ingesting substances, weakening the conditioned association between substance use cues and actual substance use. The HelixVR digital therapeutic is a modular VRCE based software that allows for simulations to be tailored to each patient and is designed for use as an adjunctive treatment for OUD/StUD under the supervision of a licensed master’s level behavioral health provider. Phase I work to be completed will include refinement of the user interface and increasing the number of features offered within the software. In Phase I we will conduct a pilot effectiveness study to investigate the impact of HelixVR on substance craving, substance use and overall quality of life. Participants (n = 50) will be randomized to receive 4 sessions of HelixVR or another active VR based intervention at an outpatient substance use treatment organization. Our Phase I hypothesis is that the addition of the fully immersive and tailored HelixVR intervention into routine treatment will be associated with increased treatment completion, decreased substance craving and decreased substance use relative to a non-tailored less immersive VR intervention. This work will be followed by a Phase II study to expand the number of cues and environments available while conducting a muti-site RCT (n = 200) to further evaluate the effectiveness of HelixVR. Our Phase II hypothesis is that the use of the HelixVR digital therapeutic will result in decreased craving and substance use, as well as decreased return to use, emergency healthcare usage, involvement with child welfare and involvement with the criminal justice system. We anticipate that these changes will be maintained for 12 months post treatment. We will continuously adjust our business plan, software content and clinical workflow integration protocols based on feedback from our target customer demographics. Our long-term goal is to offer a high impact digital therapeutic which is easily integrated into clinicians’ normal workflow, decreasing the significant social and public health impact of OUD/StUD.

项目总结 阿片类药物和/或兴奋剂使用障碍(OUD/STUD)是一种慢性、复发性疾病，如果不治疗，就会出现 一个重大且持续的公共健康和安全威胁，仅在美国就与OUD相关的成本 每年超过一万亿美元。虚拟现实线索曝光(VRCE)采用安全和受控 反复暴露于各种物质使用线索和环境中，旨在诱导 虚拟空间。由于健康和安全方面的考虑，这可以以一种不可行的方式在体内完成，填充 目前治疗OUD/STUD的非药物治疗方法持续存在缺口。当在 在虚拟环境中，患者将习惯于使用提示并与治疗师合作学习 在不摄入物质的情况下容忍渴望的应对技巧，削弱条件性联想 物质使用线索和实际物质使用之间的差异。HelixVR数字治疗仪是一个模块化的VRCE 基于软件，允许为每个患者量身定做模拟，并设计为用作 在有执照的硕士级别行为健康监督下对OUD/STOP进行辅助治疗 提供商。 要完成的第一阶段工作将包括改进用户界面和增加 软件中提供的功能。在第一阶段，我们会进行一项试验成效研究，以调查 HelixVR对物质渴求、物质使用和总体生活质量的影响。参与者(n=50)将是 随机接受4次HelixVR或另一种基于主动VR的门诊物质干预 使用治疗组织。我们的第一阶段假设是添加完全身临其境和量身定制的 将HelixVR干预纳入常规治疗将增加治疗完成率，减少 与非定制、不那么身临其境的VR干预相比，对物质的渴望和减少的物质使用。 这项工作之后将进行第二阶段研究，以扩大可用线索和环境的数量，同时 进行多点随机对照试验(n=200)，以进一步评价HelixVR的疗效。我们的第二阶段假设 HelixVR数字治疗的使用将减少渴望和物质使用，以及 减少重新使用、紧急医疗保健使用、参与儿童福利和参与 刑事司法系统。我们预计这些变化将在治疗后12个月内保持。我们 将不断调整我们的业务计划、软件内容和临床工作流程集成协议 根据我们目标客户人口统计数据的反馈。我们的长期目标是提供高影响力的数字 易于集成到临床医生的正常工作流程中的治疗方法，减少了显著的 母牛/种马对社会和公共卫生的影响。