Development of an integrated intervention involving recovery coaching and cognitive behavioral therapy for opioid use disorder

项目总结/摘要 阿片类药物使用障碍（OUD）在美国引发了前所未有的公共卫生危机。一个 估计有210万人患有阿片类药物使用障碍，尽管这些数字可能被低估。 阿片类药物的流行在美国造成了惊人的死亡，导致阿片类药物相关的过量， 急诊和住院治疗。阿片类药物使用障碍（MOUD），包括 美沙酮和丁丙诺啡已被证明是治疗OUD的有效药理学策略， 与死亡率降低有关。不幸的是，药物保留是次优的;只有56.8%的 开始丁丙诺啡的个体在6个月后保留。另一个主要问题是， 与多种共病物质使用障碍（SUD）相关。因此，将其他战略纳入 旨在解决这些缺陷的丁丙诺啡方案是必要的。 认知行为疗法（CBT）是治疗SUD最常用的干预措施之一， 被广泛认为是一种基于证据的干预措施。不幸的是，迄今为止的研究还没有证明， 在MOUD中加入面对面的CBT来治疗OUD可以减少药物使用或增加治疗保留率， 出勤率或药物依从性。然而，最近一项基于网络的CBT（CBT 4CBT-Buprenorphine）研究 提供了关于CBT作为丁丙诺啡添加剂的初步疗效的有利结果。 由具有药物使用经验和成功的个人提供的康复辅导服务 康复涉及一种非临床的同伴支持形式，旨在帮助SUD患者实现 保持恢复。在最近的一项系统综述中，我们证明了使用恢复教练对人们来说， OUD患者的生活与MOUD启动的增加有关，包括丁丙诺啡和美沙酮。在 此外，事实证明，利用康复教练有助于减少类阿片的使用。然而，复苏 教练还没有被证明可以改善那些已经在MOUD上的人的结果。在一项小型试点研究中，我们 证明了将恢复教练（与断言社区参与模型）和 CBT 4CBT-Buprenorphine减少了非法药物的使用，优化了健康的社会决定因素。 我们提出了一个综合干预结合RC和CBT。我们假设这两种成分 将改善行为技能与CBT 4CBT-Buprenorphine教学离散技能和RC提供的作用 建模，加强技能和实践，提供社会支持（情感/信息，有形，深情 和积极的社会互动），并激励参与者完成模块和家庭作业，这将导致 减少药物使用和增加记忆力。 本提案的具体目的是：（1）进行一项3组随机临床试验，以评估 综合康复教练+CBT 4CBT-丁丙诺啡干预与CBT 4CBT-丁丙诺啡干预的疗效 丁丙诺啡vs.治疗作为药物（N=90）;（2）研究综合干预是否减少 线索反应性和提高抑制控制;（3）完善我们的恢复教练+CBT 4CBT-Buprenorphine 多中心R 01临床试验的干预。

PROJECT SUMMARY/ABSTRACT Opioid use disorder (OUD) has led to an unprecedented public health crisis in the United States. An estimated 2.1 million people have opioid use disorder, although these numbers are likely to be underestimated. The opioid epidemic has caused a staggering toll in the US in terms of causing opioid-related overdoses, emergency department visits, and hospitalizations. Medications for opioid use disorder (MOUD), including methadone and buprenorphine, have proven to be effective pharmacologic strategies for treating OUD and are associated with decreased mortality. Unfortunately, retention to medication is suboptimal; only 56.8% of individuals who initiate buprenorphine are retained 6 months later. Another major issue in this population is related to multiple comorbid substance use disorders (SUDs). Thus, the incorporation of additional strategies in the buprenorphine protocols aimed at addressing these deficits is warranted. Cognitive-behavioral Therapy (CBT) is one of the most used interventions for treating SUDs and is broadly recognized as an evidence-based intervention. Unfortunately, studies to date have not demonstrated that adding in-person CBT to MOUD for treating OUD reduce drug use or increase treatment retention, attendance, or medication adherence. However, a recent study of web-based CBT (CBT4CBT-Buprenorphine) provided favorable results regarding the preliminary efficacy of CBT as an add-on to buprenorphine. Recovery coaching (RC) services provided by individuals with substance use experience and successful recovery involve a form of nonclinical, peer support aimed at helping individuals with SUDs to achieve and maintain recovery. In a recent systematic review, we demonstrated that the use of recovery coaches for people living with OUD is associated with increases in MOUD initiation, including buprenorphine and methadone. In addition, the utilization of recovery coaches was proven to be useful in decreasing opioid use. However, recovery coaches have not yet been shown to improve outcomes for those already on MOUD. In a small pilot study, we demonstrated that combining recovery coaching (with the model of Assertive Community Engagement) and CBT4CBT-Buprenorphine led to decreased illicit drug use and optimized social determinants of health. We propose an integrated intervention combining RC and CBT. We hypothesize that both components will improve behavioral skills with CBT4CBT-Buprenorphine teaching discrete skills and RC providing role modeling, reinforcing skills and practice, providing social support (emotional/informational, tangible, affectionate and positive social interaction), and motivating participants to complete modules and homework, which will result in decreased substance use and increased retention. The specific aims of this proposal are: (1) to conduct a 3-arm randomized clinical trial to evaluate the efficacy of the integrated Recovery Coach + CBT4CBT-Buprenorphine intervention vs. CBT4CBT- Buprenorphine vs. Treatment as Usual (N=90); (2) to investigate whether the integrated intervention reduces cue-reactivity and improves inhibitory control; (3) to refine our Recovery Coach + CBT4CBT-Buprenorphine intervention for a multi-site R01 clinical trial.