Mindful Body Awareness Training as an Adjunct to Medication Assisted Treatment for Opioid Use Disorder: An ancillary study

摘要 国家阿片类药物流行病需要开发基于现实世界证据的治疗方法， 阿片类药物使用障碍，包括对药物辅助治疗（MAT）的依赖， 丁丙诺啡需要采取干预措施，以满足患者的复杂需求， 阿片类药物使用障碍，其中包括大量的精神健康共病和高发病率， 与阿片类药物止痛处方和阿片类药物使用的复杂相互作用相关的慢性疼痛 disorder.这项研究利用了最近联邦和州阿片类药物使用障碍的治疗 作为一个平台，测试一个有前途的身心干预，正念意识， 身体导向疗法（MABT）作为辅助MAT在三个临床设置资助通过 华盛顿阿片类药物州定向反应（STR）计划。每个设置都使用一个 国家认可的马萨诸塞州护士护理经理模型的变体。使用 随机重复测量设计，我们将比较接受MABT+ MAT的患者与 MAT而已。本申请的首要目标是测试MABT以改善MAT结果 在接受丁丙诺啡治疗OUD的患者中。本R 01研究的主要目的 将最终结果延长至12个月，但在其他方面与母体R33相同。第一 目的是评估MABT + MAT与仅MAT相比的有效性（作为 减少阿片类药物使用（主要假设）和非阿片类药物使用（次要假设 假设12个月。目标2将检查MABT + MAT的有效性， 精神和身体健康困扰（即抑郁和焦虑的症状;情绪良好， 存在，以及身体症状和疼痛严重程度/干扰）与12岁时仅MAT相比 个月目标3将检查MABT + MAT与仅MAT相比的有效性， 积极影响物质使用相关的结果，如渴望和治疗保留在12 个月一个额外的探索性目标（目标4）将探索增加 MABT无应答者的MABT剂量。这项研究的结果将为以下方面提供证据基础： 行为治疗不适用于丁丙诺啡的MAT，并直接影响未来 在华盛顿州阿片类药物使用障碍治疗的方向。

Abstract The national opioid epidemic requires development of real-world evidence based treatments for opioid use disorder, including adjuncts to Medication Assisted Treatment (MAT) with buprenorphine. Interventions are needed that address the complex needs of patients with opioid use disorder, which include substantial mental health co-morbidity and high rates of chronic pain related to the complex interaction of opioid prescribing for pain and opioid use disorder. This study takes advantage of recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MAT in three clinical settings funded through the Washington Opioid State Targeted Response (STR) program. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, repeated measures design, we will compare those who receive MABT+ MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT outcomes among patients receiving buprenorphine to treat OUD. The primary aims for this R01 study extend the final outcome to 12 months, but are otherwise the same as the parent R33. The first aim is to evaluate the effectiveness of MABT + MAT compared to MAT only (treatment-as- usual) in reducing opioid use (primary hypothesis) and non-opioid substance use (secondary hypothesis) at 12 months. Aim 2 will examine the effectiveness of MABT + MAT to improve mental and physical health distress (i.e. symptoms of depression and anxiety; emotional well- being, and physical symptoms and pain severity/interference) compared to MAT only at 12 months. Aim 3 will examine the effectiveness of MABT + MAT compared to MAT only to positively affect substance use related outcomes such as craving and treatment retention at 12 months. An additional exploratory aim (Aim 4) will explore the effectiveness of an increased MABT dose for MABT non-responders. Results of this study will inform the evidence base for behavioral treatment adjuncts to MAT with buprenorphine and directly impact the future direction of opioid use disorder treatment in Washington State.