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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要该第一阶段项目是一项试点随机临床试验，旨在展示新型虚拟技术的商业潜力我们建议测试我们的辅助干预措施，为第二阶段的开发做准备。在阿片类药物使用障碍 (OUD) 早期恢复过程中减少阿片类药物使用和提高戒断效果人们的自我报告和对未来结果的关注也随之增加。定向是 OUD 和其他成瘾的一个标志，康复尝试通常会在 6 个月内失败。治疗方面，疗效还有很大的提升空间，包括我们的初步证据。数据表明，增加对未来的可视化应该可以改善我们的试点测试。干预的结果是有希望的，N=18 名参与者中有 14 名在 30 天后保持戒酒；值得注意的是，14 名戒烟者中有 10 名对干预措施表现出积极反应，即 100% 的响应者保持禁欲——表明 VR 干预增加了未来的自我认同。从物质使用障碍中恢复并参与大脑网络管理的人们的延迟奖励此外，VR 对延迟奖励的影响与内省执行大脑相关。连接性扩展了之前关于情景未来思维的工作，我们采用了个性化的、沉浸式的虚拟技术。整合个人细节并最大化感官参与的体验会增加。通过与未来的自己在不同的未来中进行现实互动，与未来建立联系重要的是，我们整合了自我差异理论，关注鲜明的对比。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颖性和早期康复的参与者进入一个现实的虚拟世界，体验的情感显着性。引入时间旅行叙事，并与 15 岁以后的两个数字年龄增长的未来自我互动；持续多年的阿片类药物滥用，另一个在 15 年康复后与参与者交谈。关于他们的康复奖励，或因恢复习惯性吸毒而造成的损失，以及在此期间的个人挣扎迭代开发之后，重点强调代理、乐观和决策。以及可行性和安全性测试，该范式产生了有希望的功效信号、行为改变和当前的提案将在更广泛的范围内验证这一范例。同质 OUD 样本，使用相同的 VR 范例来显示功效和行为机制。将测试阿片类药物使用结果（使用天数和戒断天数）的功效，并在 30 岁时进行纵向评估目标 2 将通过测试未来自我认同、未来方向的变化来确定机制。第一阶段的成功验证将有助于过渡到第二阶段。商业化应用，目标是创建适销对路、价格实惠、用户友好的软件产品促进临床环境中更好的康复结果。