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

针对阿片类药物使用障碍中短暂渴望的移动执行功能干预

基本信息

批准号：
10204437
负责人：
Andrew D Peckham
金额：
$ 17.46万
依托单位：
MCLEAN HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10204437
关键词：
Address Adult Aftercare Attenuated Benchmarking Buprenorphine Cellular Phone Clinical Cognitive Control Groups Cues Data Development Disease Management Distant Ecological momentary assessment Etiology Feedback Future Goals Grant Helping to End Addiction Long-term Heroin Users Human Individual Inpatients Intervention K-Series Research Career Programs Laboratories Laboratory Study Life Maintenance Measures Mentors Methadone Methods Modeling Opioid Outcome Participant Pathway interactions Patients Performance Phase Preparation Process Randomized Relapse Reporting Research Research Personnel Residential Treatment Resources Sampling Short-Term Memory Statistical Methods Surveys Technology Testing Time Training Training Support Treatment Efficacy United States National Institutes of Health acceptability and feasibility active method base career cognitive process comparison group craving design efficacy evaluation efficacy testing executive function experience experimental study follow-up group intervention handheld mobile device in vivo iterative design mHealth medication compliance mobile application novel opioid epidemic opioid use opioid use disorder persistent symptom prescription opioid recruit relapse prediction relapse risk research and development response skills smartphone based assessment substance use therapy design therapy development treatment strategy

项目摘要

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.

项目概要/摘要即使接受美沙酮或丁丙诺啡维持治疗，许多患有阿片类药物使用障碍的人（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，越来越多的人有证据表明，对 OUD 的渴望预示着人们会重新使用 OUD，并破坏现有的 OUD 治疗方法，因此，开发新的干预措施来减少渴望是解决阿片类药物危机的首要任务（NIH HEAL 倡议研究计划，2019）。执行功能的缺陷，特别是工作记忆的缺陷，是一个核心问题。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可以增强抵抗渴望的能力。这表明患有 OUD 的人可能会从在特定时间参与工作记忆任务中受益。渴爱发生的时刻。尽管之前的研究表明工作记忆“训练”并不改善 OUD 的临床结果，这些研究目前尚未提供渴望的培训实际上发生在日常生活中。因此，在渴望发生的那一刻从事工作记忆任务可能会大概可以帮助 OUD 患者控制这种持续症状，但这尚未经过测试。此外，使用生态瞬时评估 (EMA) 方法的研究表明，患有 OUD 的人可以准确追踪日常生活中渴望的每时每刻的波动，这表明这可能是在报告渴望时，可以对渴望进行干预。这项研究将测试将移动认知干预嵌入到 OUD 患者的 EMA 设计中的功效。使用美国国立卫生研究院干预开发的阶段模型，该项目的第 1A 阶段将优化工作记忆干预基于 OUD 患者样本 (n = 20) 的迭代反馈，为 1B 阶段试验做准备使用随机设计。在此试验中，拥有 OUD 的参与者 (n = 60) 将在以下地点完成为期两周的 EMA 研究：他们每天完成五次基于智能手机的渴望评估。当报告有渴望时，包含工作记忆干预的移动应用程序将激活。一半的参与者将完成干预任务，一半完成控制任务。试验结束时，参与者将在可行性阶段被授予不受限制的干预措施。结果包括改变瞬间的渴望、工作记忆性能的变化以及可行性和可接受性，包括使用随访期间的干预。还将评估药物使用情况。该项目支持申请人利用认知机制进行 OUD 治疗开发研究的目标。申请人将接受有关 OUD 病因和治疗、渴望、移动干预开发和以人为本的干预措施设计以及密集纵向数据分析。其重点在于改变渴望时刻的认知过程，在患者的日常生活中使用移动设备，这该项目有可能揭示解决 OUD 复发的重要预测因素的新途径。