Virtual Reality Facilitation of Recovery from Opioid Use Disorder

虚拟现实促进阿片类药物使用障碍的恢复

• 批准号: 10390733
• 负责人: Andrew Nelson
• 金额: $ 31.95万
• 依托单位: RELATE XR, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10390733
• 关键词: Abstinence; Adjuvant; Affect; Age; Agonist; Attention; Behavior; Behavior Disorders; Behavioral; Behavioral Mechanisms; Brain; Clinical; Clinical Trials Design; Collaborations; Computer software; Control Groups; Data; Decision Making; Development; Devices; Drug usage; Emotional; Episodic memory; Event; Executive Dysfunction; Future; Goals; Health Personnel; Immersion; Impairment; Individual; Intellectual Property; Intervention; Intoxication; Laboratories; Medical Device; Methods; Opioid; Outcome; Participant; Patient Self-Report; Patients; Persons; Pharmacotherapy; Phase; Pilot Projects; Preparation; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Relapse; Rewards; Rights; Risk; Sampling; Sensory; Signal Transduction; Substance Use Disorder; Substance abuse problem; Testing; Therapeutic; Thinking; Time; Travel; Treatment Efficacy; Treatment outcome; Validation; Visualization; Withdrawal; Work; addiction; cognitive function; commercial application; commercialization; comparison intervention; cost; craving; design; digital; discounting; disorder later incidence prevention; efficacy testing; executive function; experience; feasibility testing; follow-up; improved; male; medication-assisted treatment; non-drug; novel; opioid abuse; opioid agonist therapy; opioid use; opioid use disorder; optimism; personalized medicine; pilot test; precision medicine; preference; response; safety and feasibility; theories; user friendly software; virtual; virtual reality; virtual reality intervention; virtual world

PROJECT SUMMARY / ABSTRACT This Phase I project is a pilot randomized clinical trial designed to show commercial potential for a novel virtual reality intervention in preparation for Phase II development. We propose testing our adjunctive intervention for efficacy on reducing opioid use and increasing abstinence in early recovering opioid use disorder (OUD) persons, with concomitant increases in self-reported and behavioral focus on future outcomes. Impaired future orientation is a hallmark of OUD and other addictions. With recovery attempts usually failing within 6 months of treatment, there is considerable room for improved efficacy. Converging evidence, including our preliminary data, indicates that increasing visualization of the future should improve recovery outcomes. Our pilot testing of the intervention was promising, with n=14 out of N=18 participants remaining abstinent 30 days later; importantly, 10 of the 14 abstainers showed a positive response to the intervention, i.e., 100% of responders remained abstinent—suggesting an efficacy marker. The VR intervention increased future self-identification and delay-of-reward in people recovering from substance use disorder and engaged brain networks governing prospection. Further, the VR effect on delay-of-reward correlated with introspective-executive brain connectivity. Extending prior work on episodic future thinking, we employed a personalized, immersive virtual experience that integrates personal details and maximizes sensory engagement. Our intervention increases connectedness with one’s future through a realistic interaction with Future Selves in diverging futures resulting from different choices. Importantly, we integrate self-discrepancy theory, focusing on the stark contrast between these futures to heighten impact, and we promote engagement by maximizing the novelty and emotional salience of the experience. Participants in early recovery enter a realistic virtual world, are introduced to a time travel narrative, and interact with two digitally age-progressed Future Selves; one after 15 years of ongoing opioid abuse, and the other after 15 years of recovery. Future Selves speak to the participant about their recovery rewards, or losses from returning to habitual drug use, and personal struggles during the journey. Strong emphasis is placed on agency, optimism, and decision-making. After iterative development and tests of feasibility and safety, the paradigm yielded a promising efficacy signal, behavioral change, and brain target engagement. The current proposal will validate this paradigm in an expanded and more homogenous OUD sample to show efficacy and behavioral mechanisms using the same VR paradigm. Aim 1 will test for efficacy on opioid use outcomes (days of use and abstinence) with longitudinal assessments at 30 days. Aim 2 will determine mechanisms by testing for changes in future self-identification, future orientation, and behavioral delay discounting. Successful validation in Phase I will enable transition into a Phase II commercialization application, with the goal of creating a marketable, affordable, user-friendly software product for facilitating better recovery outcomes in clinical settings.

项目总结/摘要 该I期项目是一项试点随机临床试验，旨在显示一种新型虚拟药物的商业潜力。 为第二阶段的发展做准备。我们建议测试我们的预防性干预措施， 减少阿片类药物使用和增加早期恢复性阿片类药物使用障碍（OUD）戒断的疗效 的人，伴随着自我报告和对未来结果的行为关注的增加。受损的未来 定向是OUD和其他成瘾的标志。恢复尝试通常在6个月内失败 在治疗方面，有相当大的改善功效的空间。汇聚的证据，包括我们初步的 数据表明，增加对未来的可视化应该会改善恢复结果。我们的试点测试 的干预是有希望的，与n=14的N=18参与者保持禁欲30天后; 重要的是，14名弃权者中有10名对干预表现出积极的反应，即，100%响应者 保持禁欲--这表明它是一种有效的标志物。VR干预增加了未来的自我认同 以及从物质使用障碍中恢复过来的人的奖励延迟， 勘探此外，VR对延迟奖励的影响与内省-执行脑相关 连通性。扩展以前的工作情节未来的思维，我们采用了个性化的，身临其境的虚拟 整合个人细节并最大化感官参与的体验。我们的干预增加 通过与未来自我的现实互动，在不同的未来中与未来自我建立联系， 不同的选择。重要的是，我们整合了自我差异理论，专注于鲜明的对比， 这些未来之间的联系，以提高影响力，我们通过最大限度地提高新奇性， 体验的情绪突出性。早期恢复的参与者进入一个现实的虚拟世界， 介绍了一个时间旅行的故事，并与两个数字年龄进展的未来自我互动;一个是15岁后 一个是持续多年的阿片类药物滥用，另一个是经过15年的康复。未来的自我对参与者说话 关于他们的恢复奖励，或从恢复到习惯性吸毒的损失，以及在治疗期间的个人斗争， 旅程强烈强调的是机构，乐观和决策。经过迭代开发 以及可行性和安全性的测试，该范例产生了有希望的功效信号，行为变化， 大脑目标参与。目前的建议将验证这一模式，在扩大和更多的 使用相同的VR范例，对同质OUD样本进行了验证，以显示功效和行为机制。要求1 将在30岁时进行纵向评估，检测阿片类药物使用结局（使用和戒断天数）的疗效 天目标2将通过测试未来自我认同、未来取向、 和行为延迟折扣。第一阶段的成功验证将使过渡到第二阶段 商业化应用程序，目标是创建一个适销对路，负担得起，用户友好的软件产品 以促进临床环境中更好的恢复结果。