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

项目总结/摘要 即使接受美沙酮或丁丙诺啡维持治疗，许多阿片类药物使用障碍患者 (OUD)继续体验渴望。在海洛因使用者和处方阿片类药物使用者中， 有证据表明，渴望预测返回使用，并破坏现有的治疗OUD，因此， 开发新的干预措施以减少对阿片类药物的渴望是解决阿片类药物危机的优先事项（NIH HEAL 研究计划，2019年）。执行功能的缺陷，特别是工作记忆，是一个核心问题。 这是一种破坏抑制渴望能力的机制。非临床样本的实验室研究表明， 在渴望诱导之前或期间参与工作记忆任务增加了抵抗渴望的能力。 这表明，OUD患者可能会从特定时间的工作记忆任务中受益。 当渴望发生的时候。尽管先前的研究表明，工作记忆“训练”并不 改善OUD的临床结果，这些研究还没有在渴望的时刻提供培训， 实际上发生在日常生活中。因此，在渴望产生的那一刻， 可能有助于OUD患者控制这种持续性症状，但尚未经过测试。 此外，使用生态瞬时评估（EMA）方法的研究表明，OUD患者可以 准确地跟踪他们日常生活中渴望的每时每刻的波动，这表明它可能是 在报告渴望的那一刻提供干预措施是可行的。这项研究将测试 在OUD患者中将移动的认知干预嵌入EMA设计的有效性。使用NIH 干预发展的阶段模型，本项目的第1A阶段将优化工作记忆干预 基于OUD患者样本（n = 20）的反复反馈，为1B期试验做准备 使用随机设计。在本试验中，OUD受试者（n = 60）将在 他们每天完成五次基于智能手机的渴望评估。当报告渴望时， 包含工作记忆干预的移动的应用程序将被激活。一半的参与者将 完成干预，而一半将完成控制任务。在试验结束时，参与者将 在可行性阶段，被授予不受限制地进入干预措施的权利。成果包括： 瞬时渴望，工作记忆表现的变化，以及可行性和可接受性，包括使用 在随访期间进行干预。还将评估物质使用情况。该项目支持申请人的 目标是利用认知机制来进行OUD的治疗开发研究。申请人 将接受OUD的病因学和治疗、渴求、移动的干预发展方面的培训， 以人为本的干预措施设计和密集的纵向数据分析。将重点放在 在患者的日常生活中使用移动的设备， 该项目有可能揭示解决OUD复发的重要预测因素的新途径。

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.