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.

项目概要 阿片类药物和/或兴奋剂使用障碍 (OUD/StUD) 是一种慢性、反复发作的疾病，如果不及时治疗，可能会导致 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 虚拟现实提示曝光 (VRCE) 采用安全可控的技术 反复暴露于各种旨在诱发渴望的物质使用线索和环境 由于健康和安全问题，这可以通过“体内”不可行的方式来完成，从而填补了空白。 目前 OUD/StUD 的非药物治疗方法持续存在差距。 在虚拟环境中，患者将习惯物质使用线索并与治疗师一起学习 在不摄入物质的情况下忍受渴望的应对技巧，削弱条件联系 HelixVR 数字治疗仪是一种模块化 VRCE。 基于软件，允许为每个患者量身定制模拟，并且被设计用作 在获得许可的硕士学位行为健康监督下对 OUD/StUD 进行辅助治疗 提供者。 待完成的第一阶段工作将包括完善用户界面并增加 在第一阶段，我们将进行试点有效性研究来调查软件中提供的功能。 HelixVR 对物质渴望、物质使用和整体生活质量的影响将被纳入参与者（n = 50）。 随机在门诊接受 4 次 HelixVR 或其他基于主动 VR 的干预 我们的第一阶段假设是添加完全沉浸式和量身定制的治疗。 HelixVR 对常规治疗的干预将与治疗完成率的提高、治疗的减少有关 相对于非定制的沉浸式 VR 干预，物质渴望和物质使用减少。 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 进行多中心随机对照试验（n = 200）以进一步评估我们的 II 期假设的有效性。 使用 HelixVR 数字治疗将减少渴望和物质使用，以及 恢复使用、紧急医疗保健使用、儿童福利参与和参与 我们预计这些变化将在治疗后维持 12 个月。 将根据业务计划、软件内容和临床工作流程整合协议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 我们的长期目标是提供具有高影响力的数字化服务。 治疗很容易集成到受欢迎的正常工作流程中，从而显着减少 OUD/StUD 的社会和公共卫生影响。