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

正念身体意识训练作为阿片类药物使用障碍药物辅助治疗的辅助手段：一项辅助研究

• 批准号: 9893166
• 负责人: JOSEPH O MERRILL
• 金额: $ 223.53万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-28 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9893166
• 关键词: Abstinence; Address; Adherence; Adopted; Adult; Affect; Affective; Alcohol or Other Drugs use; American; Ancillary Study; Anxiety; Awareness; Behavior Therapy; Behavioral; Behavioral Research; Benzodiazepines; Buprenorphine; Care given by nurses; Case Manager; Chronic stress; Clinical; Clinical Trials; Cocaine; Comorbidity; Complex; Data; Development; Distress; Dose; Effectiveness; Epidemic; Evidence based treatment; Functional disorder; Funding; Future; Goals; HIV; Health; Healthcare; Hepatitis C virus; Heroin; Interoception; Intervention; Maintenance; Massachusetts; Measures; Medicaid; Mental Depression; Mental Health; Methadone; Methamphetamine; Mind-Body Intervention; Modeling; Morbidity - disease rate; National Institute of Drug Abuse; Neurocognitive; Opioid; Outcome; Overdose; Pain; Parents; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Physicians; Policies; Price; Primary Health Care; Psyche structure; Randomized; Regulation; Relapse; Research; Research Design; Role; Rural; Sample Size; Self Care; Severities; Site; Stress; Substance Use Disorder; System; Testing; Training; Treatment outcome; United States; United States Substance Abuse and Mental Health Services Administration; Variant; Washington; Well in self; addiction; base; behavior change; buprenorphine treatment; chronic pain; cost; craving; depressive symptoms; design; effective intervention; emotion dysregulation; emotion regulation; evidence base; illicit opioid; improved; innovation; medication-assisted treatment; mindfulness; mortality; non-opioid analgesic; novel; opioid agonist therapy; opioid epidemic; opioid overdose; opioid use; opioid use disorder; physical conditioning; physical symptom; prescription opioid; programs; reduced substance use; relapse risk; response; rural area; rural setting; skills; social; success; therapy design; treatment as usual; treatment optimization; treatment program; urban setting

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.

抽象的 全国阿片类药物流行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，包括药物辅助治疗 (MAT) 的辅助治疗 丁丙诺啡。需要采取干预措施来满足患者的复杂需求 阿片类药物使用障碍，包括大量的心理健康合并症和高比例的阿片类药物使用障碍 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有关的慢性疼痛 紊乱。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 倡议作为测试有前途的身心干预的平台，即“正念意识” 身体导向疗法 (MABT) 作为 MAT 的辅助手段，在三个临床环境中通过以下方式资助： 华盛顿阿片类药物州针对性响应 (STR) 计划。每个设置都采用一个 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 的患者与接受 MABT+ MAT 的患者 仅垫。此应用程序的总体目标是测试 MABT 以改善 MAT 结果 接受丁丙诺啡治疗 OUD 的患者。本 R01 研究的主要目标 将最终结果延长至 12 个月，但其他方面与母版 R33 相同。第一个 目的是评估 MABT + MAT 与仅 MAT 相比的有效性（治疗作为- 通常）减少阿片类药物的使用（主要假设）和非阿片类物质的使用（次要假设） 假设）12 个月时。目标 2 将检查 MABT + MAT 改善的有效性 精神和身体健康困扰（即抑郁和焦虑的症状；情绪良好 以及身体症状和疼痛严重程度/干扰）与仅 12 时的 MAT 相比 几个月。目标 3 将检查 MABT + MAT 与 MAT 相比的有效性，仅 对物质使用相关的结果产生积极影响，例如 12 岁时的渴望和治疗保留 几个月。另一个探索性目标（目标 4）将探索增强的有效性 MABT 无反应的 MABT 剂量。这项研究的结果将为以下方面提供证据基础： 行为治疗辅助丁丙诺啡 MAT 并直接影响未来 华盛顿州阿片类药物使用障碍治疗的方向。