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.

项目摘要 阿片类药物和/或刺激性使用障碍（OUD/Stud）是慢性的，经常性的疾病，如果未经治疗，则姿势 一个重大且持续的公共卫生和安全威胁，仅在美国与Oud相关的成本 每年超过一万亿美元。虚拟现实提示曝光（VRCE）员工安全且受控 反复接触各种物质的使用线索和环境，旨在引起渴望 虚拟空间。由于健康和安全问题，这可以以不可行的“体内”方式完成，从而填补 目前的治疗方法中的持续差距是OUD/Stud的非药物治疗。同时在 虚拟环境，患者将习惯于使用提示，并与治疗师一起学习 应对耐心同时不摄入物质的渴望的技能，削弱条件关联 在物质使用线索和实际使用物质之间。 HelixVR数字疗法是模块化VRCE 基于基于的软件，允许对每个患者量身定制模拟，并设计用于用作 在有执照的大师级别的行为健康的监督下，OUD/Stud的辅助治疗 提供者。 要完成的第一阶段工作将包括对用户界面的完善和增加的数量 软件中提供的功能。在第一阶段，我们将进行一项试验效率研究，以研究 HelixVr对渴望，物质使用和整体生活质量的影响。参与者（n = 50）将是 随机将4个疗程的HelixVR或其他基于Active VR的干预在门诊子板上 使用治疗组织。我们的I阶段假设是添加完全沉浸式和量身定制的 HelixVR干预常规治疗将与治疗的完成相关，减少 相对于非少量沉浸式VR干预，物质渴望和改善的物质使用。 这项工作将进行第二阶段研究，以扩大可用的提示和环境的数量 进行相互位点RCT（n = 200），以进一步评估HelixVr的有效性。我们的II期假设 是使用HelixVR数字疗法会导致渴望和使用物质的减少以及 减少使用返回，紧急医疗保健使用情况，参与儿童福利以及参与 刑事司法系统。我们预计这些变化将在治疗后12个月进行。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 关于我们的目标客户人口统计的反馈。我们的长期目标是提供高影响力数字 可以轻松整合到临床医生正常工作流程中的治疗性，从而减少了重要 OUD/Stud的社会和公共卫生影响。