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: 10467167
• 负责人: MARC FISHMAN
• 金额: $ 246.57万
• 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/10467167
• 关键词: Acute; Address; Adherence; Affect; Age; Assertiveness; Attitude; Back; Baltimore; Behavior; Behavioral; Buprenorphine; Chronic; Communities; Development; Disease; Distress; Dose; Drug usage; Effectiveness; Elderly; Family; Family member; Feedback; Focus Groups; Formulation; Future; HIV; HIV risk; Health; Home; Incentives; Inpatients; Intervention; Modeling; Modification; Monitor; Naltrexone; Opioid; Outcome; Overdose; Participant; Patient Self-Report; Pharmaceutical Preparations; Phase; Population; Preparation; Public Health; Randomized; Randomized Controlled Trials; Recovery; Relapse; Risk Behaviors; Schizophrenia; Self Efficacy; Series; Site; Special Population; Testing; Text; Text Messaging; Time; Training; Urine; Vulnerable Populations; Work; Youth; barrier to care; base; contingency management; criminal behavior; disorder later incidence prevention; economic evaluation; efficacy testing; high risk; high risk population; improved; innovation; intervention refinement; knowledge base; medication compliance; opioid epidemic; opioid use; opioid use disorder; outreach; prescription opioid; prevent; primary outcome; psychiatric symptom; relative effectiveness; secondary outcome; social media; substance use; treatment as usual; treatment center; treatment planning; treatment program; young adult

Project Summary/Abstract: Young people are disproportionately affected by the current opioid crisis including worse retention and outcomes compared to older adults. Further, young adults typically do not have access to medications for opioid use disorder (OUD), and for those that do, struggles with adherence are a major barrier. Standard approaches to treatment typically do not incorporate developmentally informed strategies for engagement, retention, and medication adherence for this special population. The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR- NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence. YORS is currently showing very promising results in a small pilot RCT by the investigative team. We propose to refine and then conduct a more definitive test of the YORS intervention for youth with OUD using the R61/R33 mechanism. In the R61 phase we will conduct stakeholder focus groups to get input and feedback on potential refinements, while also conducting 3 cycles of pilot testing of these potential refinements. Based on the R61 preparation and final synthesis of the intervention refinements, in the R33 phase we will conduct an RCT to test the efficacy of YORS, by randomizing N=120 young adults ages 18-26 seeking treatment for OUD with XR-NTX at Mountain Manor Treatment Center (MMTC), to either the refined YORS intervention or treatment as usual (TAU) for a 6-month course of treatment with XR-NTX. The primary outcome will be number of XR-NTX doses received. Secondary outcomes will include opioid relapse, days of opioid use, time to first opioid relapse, HIV risk behaviors, criminal behaviors, psychiatric symptoms, and family member distress and self-efficacy. It is hypothesized that participants in the YORS condition will receive significantly more XR-NTX doses and will demonstrate less severe opioid use and associated behaviors compared to those in the TAU group. The assertive YORS intervention has the potential to improve the real-world effectiveness and public health impact of medication for OUD in this very high-risk, vulnerable population. If the refined YORS intervention is found to be efficacious, it would set the stage for future work including: an economic analysis, a larger multi-site study, longer intervention duration, study of extended release buprenorphine, and study of step-down to less intensive interventions.

项目摘要/摘要： 年轻人受到当前阿片类药物危机的影响不成比例，包括保留率更严重和 与老年人相比的结果。此外，年轻人通常无法获得药物 阿片类药物使用障碍（OUD），对于那些遵守斗争的人是一个主要障碍。标准 治疗方法通常不会纳入发展知情的参与策略， 保留和对该特殊人群的药物依从性。 青年阿片类药物恢复支持（YORS）模型是一种创新的环绕式方法 解决这个脆弱的年轻人人口的治疗障碍，尤其是困难 用药物依从性。它的组件包括：（1）扩展发行naltrexone的送货（XR-） ntx）for Oud; （2）家庭参与协作治疗计划和监测的关注 药物依从性； （3）治疗团队的自信宣传，包括积极跟踪和 通过短信和社交媒体与青年和家庭进行交流，以促进参与和 依从性； （4）应急管理提供了依从性的激励措施。是 目前，调查小组在一个小型飞行员RCT中表现出非常有希望的结果。 我们建议改进，然后对Oud青年的YORS干预进行更确定的测试 使用R61/R33机制。在R61阶段，我们将进行利益相关者焦点小组以获取意见和 对潜在改进的反馈，同时还对这些潜在改进进行了3个循环。 根据R61的准备和干预改进的最终合成，在R33阶段，我们将 通过随机化18-26岁的120名年轻人，进行RCT测试YORS的功效 用XR-NTX在Mountain Manor治疗中心（MMTC）进行OUD的处理，要么是精制的Yors 干预或像往常一样治疗（TAU）对XR-NTX进行6个月的治疗过程。 主要结果将是收到的XR-NTX剂量的数量。次要结果将包括阿片类药物 复发，阿片类药物的使用日，第一次阿片类药物复发的时间，艾滋病毒风险行为，犯罪行为，精神病学 症状以及家庭成员的困扰和自我效能。假设Yors的参与者 疾病将获得更多的XR-NTX剂量，并且会表现出不太严重的阿片类药物使用和 与tau组的行为相比。自信的YORS干预具有潜力 在这种非常高风险的， 脆弱的人口。如果发现精致的YORS干预是有效的，它将为 未来的工作包括：经济分析，一项更大的多站点研究，更长的干预持续时间，研究 扩展释放丁丙诺啡，并研究降至不太密集的干预措施。