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.

项目摘要 /摘要 该阶段I项目是一项飞行员随机临床试验，旨在显示出新型虚拟的商业潜力 为第二阶段开发做准备的现实干预。我们建议测试我们的辅助干预措施 早期恢复阿片类药物使用障碍（OUD）减少阿片类药物使用和戒酒的功效 人类自我报告和行为关注未来结果的人。未来受损 方向是Oud和其他增加的标志。随着恢复尝试通常在6个月内失败 在治疗中，有相当大的效率空间。融合证据，包括我们的初步 数据，表明对未来的可视化增加应改善恢复结果。我们的飞行员测试 保证了干预措施，n = 14个n = 30天后仍保留的n = 14； 重要的是，14个戒酒者中有10名对干预措施有积极的反应，即100％的响应者 仍然戒酒 - 效率标记。 VR干预增加了未来的自我认同 并延迟从药物使用障碍和涉及大脑网络中恢复的人的奖励 假面。此外，VR对奖励延迟的效果与内省 - 执行的大脑相关 连接性。扩展了关于情节的未来思维的先前工作，我们从事个性化的，身临其境的虚拟 体验集成个人细节并最大化感官参与度的经验。我们的干预增加了 通过与未来自我的现实互动在不同的期货中的现实互动，从而与未来的联系 来自不同的选择。重要的是，我们整合了自我证明理论，重点是鲜明的对比 在这些期货之间增强影响力，我们通过最大化新颖性和 体验的情感显着性。早期康复的参与者进入一个现实的虚拟世界，是 引入时间旅行叙事，并与两个数字化的未来自我互动； 15岁以后 康复15年后，正在进行的阿片类药物持续滥用。未来自我与参与者说话 关于他们的恢复奖励，或从恢复习惯吸毒的损失以及在 旅行。非常重视代理，乐观和决策。迭代发展 以及可行性和安全性的测试，范式产生了有希望的效率信号，行为变化和 大脑目标参与。当前的提案将在扩展和更多的情况下验证此范式 使用相同的VR范式显示出均匀的OUD样品，以显示效率和行为机制。目标1 将测试阿片类药物使用结果的效率（使用天数和禁欲），并在30时进行纵向评估 天。 AIM 2将通过测试未来自我认同，未来取向的变化来确定机制， 和行为延迟打折。在第一阶段的成功验证将使过渡到II期 商业化应用程序，目的是创建可销售，负担得起，用户友好的软件产品 为了促进临床环境中更好的恢复结果。