The Youth Opioid Recovery Support (YORS) Intervention: An assertive community treatment model for improving medication adherence in young adults with opioid use disorder

青年阿片类药物康复支持 (YORS) 干预：一种自信的社区治疗模式，用于改善患有阿片类药物使用障碍的年轻人的药物依从性

• 批准号: 10594594
• 负责人: MARC FISHMAN
• 金额: $ 49.26万
• 依托单位: MARYLAND TREATMENT CENTERS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-28 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10594594
• 关键词: Abstinence; Address; Adherence; Administrative Supplement; Affect; Aftercare; Age; Amygdaloid structure; Anxiety; Assertiveness; Behavior Therapy; Behavior assessment; Behavioral; Behavioral Mechanisms; Biological Markers; Brain; Buprenorphine; Clinical; Cognition; Cognitive; Communities; Corpus striatum structure; Cues; Data; Data Collection; Decision Making; Development; Dose; Eligibility Determination; Emotional; Emotions; Exhibits; Face; Family; Functional Magnetic Resonance Imaging; Future; Grant; Home; Impulsivity; Injectable; Inpatients; Intervention; Investigation; Knowledge; Link; Magnetic Resonance Imaging; Measures; Mediating; Modeling; Moods; Naltrexone; National Institute of Drug Abuse; Opiate Addiction; Opioid; Outcome; Parents; Participant; Pathway Analysis; Persons; Pharmaceutical Preparations; Phenotype; Population; Process; Psychiatric Diagnosis; Randomized; Randomized Controlled Trials; Recovery Support; Relapse; Research Design; Residential Treatment; Rest; Rewards; Risk; Scanning; Selection for Treatments; Severities; System; Techniques; Treatment Efficacy; Treatment outcome; United States National Institutes of Health; Ventral Striatum; Visit; Withdrawal; Youth; adherence rate; base; behavioral phenotyping; brain behavior; cognitive reappraisal; contingency management; craving; disorder later incidence prevention; efficacy testing; executive function; functional MRI scan; improved; individual variation; innovation; interest; medication compliance; medication nonadherence; neural network; neurobehavioral; neuroimaging; neuromechanism; opioid epidemic; opioid use disorder; outreach; parent grant; parent project; pilot test; predictive modeling; prognostic; programs; prospective; protocol development; relating to nervous system; skills; social; standard of care; treatment adherence; treatment as usual; treatment program; treatment response; uptake; young adult

PROJECT SUMMARY. Young adults with opioid use disorders (OUD) are disproportionately affected by the current opioid crisis and have poorer treatment engagement and adherence compared to their older counterparts with catastrophic consequences. As such, the identification of neural networks and behavioral predictors of treatment adherence and abstinence outcomes related to relapse prevention medication treatment for OUD (termed MOUD) in young adults is of great importance and may enhance treatment refinement efforts and improve precision and efficacy of treatment matching. The purpose of this administrative supplement to NIDA R33DA056230 is to identify neurobehavioral features (brain activity, functional connectivity (FC), and cognition and social/emotional processes) at baseline that are related to medication adherence and opioid relapse (Aim 1) in young adults with OUD receiving extended-release injectable naltrexone (XR-NTX) or buprenorphine (XR-BUP) medication treatment, and investigate how these neurobehavioral features change during treatment (Aim 2). The supplement will use a mechanism-focused prospective ‘add-on’ pre-to-post-treatment study design linked to the parent grant’s randomized controlled trial (RCT) testing the efficacy of enhanced recovery support through the Youth Opioid Recovery Support (YORS) program, a developmentally-informed intervention that incorporates home delivery of MOUD, family engagement, assertive outreach, and contingency management to promote medication adherence. The parent RCT will randomize N=120 young adults ages 18-28 seeking treatment for OUD with XR-NTX or XR-BUP to either the YORS intervention or treatment as usual (TAU) for a 6-month course of MOUD treatment. In the supplement project, N=65 young adults from the parent treatment grant (estimated N=32 each choosing XR- NTX and XR-BUP) who meet MRI eligibility criteria and are randomized to receive the YORS intervention will complete pretreatment and week-12 fMRI scan visits and a pre-treatment ‘deep’ behavioral phenotyping assessment visit. During scan visits, participants will complete fMRI scans during rest, opioid cue exposure, emotional faces presentation, and reward. Data on opioid addiction severity, withdrawal, cravings, impulsivity, mood/anxiety, cognitive regulation skills, decision making, and psychiatric diagnoses will be collected during the behavioral assessment visit. Integrated aspects of the fMRI/phenotyping supplement project and main YORS study will allow for investigation of how resting-state and task-related brain activity and connectivity, and cognitive and social/emotional processes relate to opioid relapse and medication adherence and change during treatment in young adults receiving MOUD treatment. It will also allow for exploratory, albeit underpowered, analyses examining mediating effects of medication choice (XR-BUP versus XR-NTX) on relationships identified in the primary analyses between brain connectivity, opioid relapse, and treatment adherence.

项目摘要。患有阿片类药物使用障碍（OUD）的年轻人受到 目前的阿片类药物危机，与老年人相比， 带来灾难性后果的对手。因此，神经网络和行为的识别 与预防复发药物相关的治疗依从性和戒断结局的预测因素 治疗年轻人的OUD（称为MOUD）非常重要， 精细化工作，提高治疗匹配的精度和疗效。这样做的目的 NIDA R33 DA 056230的管理补充是识别神经行为特征（大脑活动， 功能连接（FC）和认知和社会/情感过程），这些过程与 接受缓释OUD的年轻成人中的药物依从性和阿片类药物复发（目的1） 注射纳洛酮（XR-NTX）或丁丙诺啡（XR-BUP）药物治疗，并研究这些 神经行为特征在治疗期间改变（目的2）。该补充将使用一种机制， 与父母资助的随机对照试验相关的前瞻性“附加”治疗前至治疗后研究设计 (RCT)通过青年阿片类药物恢复支持（YORS）测试增强恢复支持的功效 计划，一个发展知情的干预，包括家庭交付MOUD，家庭 参与，自信的外展和应急管理，以促进药物依从性。母 RCT将随机分配N=120名年龄在18-28岁之间寻求用XR-NTX或XR-BUP治疗OUD的年轻人， 在6个月的MOUD治疗过程中进行YORS干预或常规治疗（TAU）。在 补充项目，N=65名来自父母治疗补助金的年轻人（估计N=32人，每人选择XR- NTX和XR-BUP）符合MRI合格性标准并随机接受YORS干预的患者将 完成治疗前和第12周的fMRI扫描访视和治疗前“深度”行为表型分析 评估访问。在扫描访问期间，参与者将在休息，阿片类药物线索暴露， 情绪化的面孔呈现和奖励。关于阿片类药物成瘾严重程度、戒断、渴望、冲动的数据， 情绪/焦虑、认知调节技能、决策和精神病诊断将在 行为评估访问。功能磁共振成像/表型补充项目的综合方面和主要的 YORS的研究将允许调查休息状态和任务相关的大脑活动和连接， 认知和社会/情感过程与阿片类药物复发和药物依从性和变化有关 在接受MOUD治疗的年轻人中，它还将允许探索性的，尽管 检验药物选择（XR-BUP与XR-NTX）对 在主要分析中确定的脑连接、阿片类药物复发和治疗之间的关系 坚持。