A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders

项目摘要/摘要 即使在接受美沙酮或丁丙诺啡维持治疗时，许多阿片类药物使用障碍的人 继续体验渴望。在海洛因和处方阿片类药物的使用者中， 有证据表明，渴求预示着重新使用，并破坏了现有的治疗OUD的方法，因此， 开发减少渴求的新干预措施是解决阿片类药物危机的优先事项(NIH Hear 倡议研究计划，2019年)。执行功能的缺陷，特别是工作记忆的缺陷，是 破坏抑制欲望的能力的机制。非临床样本的实验室研究表明 在渴望诱导之前或过程中参与工作记忆任务可以增强抵抗渴望的能力。 这表明，有OUD的人可能会从参与特定的工作记忆任务中受益 渴望发生的那一刻。尽管先前的研究表明，工作记忆的“训练”不会 改善OUD的临床结果，这些研究在渴望的时刻还没有提供培训 实际上发生在日常生活中。因此，在渴望发生的时刻参与工作记忆任务可能会 据推测，这可能有助于患有自闭症的人管理这种持续的症状，但这还没有经过测试。 此外，使用生态瞬时评估(EMA)方法的研究表明，患有OUD的人可以 准确跟踪日常生活中渴望的时时刻刻的波动，这表明它可能是 在渴望被报告的时刻提供渴望的干预是可行的。这项研究将测试 在eMA设计中嵌入移动认知干预对OUD患者的有效性。使用美国国家卫生研究院 干预发展的阶段模型，本项目的阶段1A将优化工作记忆干预 基于来自OUD患者样本(n=20)的迭代反馈，为1B阶段试验做准备 采用随机设计。在这项试验中，患有ODS的参与者(n=60)将完成为期两周的EMA研究 他们每天五次完成基于智能手机的渴望评估。当报告渴望时，一个 包含工作记忆干预的移动应用程序将被激活。一半的参与者将 完成干预，一半完成控制任务。在试验结束时，参与者将 在可行性阶段允许不受限制地访问干预措施。结果包括以下变化 瞬间渴望，工作记忆表现的变化，以及可行性和可接受性，包括使用 在随访期进行干预。还将对物质使用情况进行评估。该项目支持申请人的 目的是利用认知机制为OUD进行治疗发展研究。申请人 将接受有关OUD的病因和治疗的培训，渴求，移动干预开发和 以人为中心的干预设计，以及密集的纵向数据分析。它的重点是 在渴望的时刻改变认知过程，在患者的日常生活中使用移动设备，这 该项目有可能揭示新的途径，以解决OUD复发的重要预测因素。

Project Summary/Abstract Even when treated with methadone or buprenorphine maintenance, many people with opioid use disorder (OUD) continue to experience craving. Among both users of heroin and users of prescription opioids, mounting evidence shows that craving predicts return to use and undermines existing treatments for OUD, thus, the development of new interventions to reduce craving is a priority for addressing the opioid crisis (NIH HEAL Initiative Research Plan, 2019). Deficits in executive functioning, particularly working memory, are a central mechanism that undermines the ability to inhibit craving. Laboratory studies in non-clinical samples show that engaging in working memory tasks before or during a craving induction increases the ability to resist craving. This suggests that people with OUD may benefit from engaging in working memory tasks at the specific moment when craving occurs. Although previous research shows that working memory “training” does not improve clinical outcomes in OUD, these studies have not delivered training at the moment that craving actually occurs in daily life. Thus, engaging in working memory tasks at the moment that craving occurs could presumably help individuals with OUD to manage this persistent symptom, but this has not been tested. Further, studies using Ecological Momentary Assessment (EMA) methods show that people with OUD can accurately track moment-to-moment fluctuations in craving in their daily lives, suggesting that it may be feasible to deliver interventions for craving in the moment when craving is reported. This study will test the efficacy of embedding a mobile cognitive intervention into an EMA design in people with OUD. Using the NIH Stage Model of Intervention Development, Stage 1A of this project will optimize a working memory intervention based on iterative feedback from a sample of people with OUD (n = 20), in preparation for a Stage 1B trial using a randomized design. In this trial, participants with OUDs (n = 60) will complete a two-week EMA study in which they complete smartphone-based assessments of craving five times daily. When craving is reported, a mobile application containing the working memory intervention will activate. Half of the participants will complete the intervention, while half will complete a control task. At the conclusion of the trial, participants will be granted unrestricted access to the intervention during a feasibility phase. Outcomes include change in momentary craving, change in working memory performance, and feasibility and acceptability, including use of the intervention during follow-up. Substance use will also be assessed. This project supports the applicant’s goal of leveraging cognitive mechanisms to conduct treatment development research for OUD. The applicant will receive training in the etiology and treatment of OUD, craving, mobile intervention development and human-centered design of interventions, and analysis of intensive longitudinal data. With its emphasis on modifying cognitive processes at the moment of craving, using mobile devices in patients’ daily lives, this project has the potential to reveal new pathways for addressing a significant predictor of relapse in OUD.