Mindful Body Awareness Training as an Adjunct to Medication Assisted Treatment for Opioid Use Disorder

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

• 批准号: 10170284
• 负责人: CYNTHIA J PRICE
• 金额: $ 61.37万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10170284
• 关键词: Abstinence; Address; Adult; American; Anxiety; Awareness; Behavior Control; Behavior Therapy; Brief Pain Inventory; Buprenorphine; Care given by nurses; Caring; Case Manager; Clinical; Clinical Trials; Complex; Consent Forms; Data; Data Collection; Development; Distress; Drug Addiction; Drug Prescriptions; Effectiveness; Emotional; Epidemic; Evidence based treatment; Functional disorder; Funding; Future; Goals; Grant; HIV; Health; Hepatitis C virus; Heroin; Individual; Interoception; Intervention; Intervention Studies; Lead; Legal; Maintenance; Manuals; Massachusetts; Measures; Medicaid; Medical; Mental Depression; Mental Health; Methadone; Mind-Body Intervention; Mindfulness Training; Modeling; Monitor; Morbidity - disease rate; National Institute of Drug Abuse; Neurocognitive; Opiate Addiction; Opioid; Outcome; Overdose; Pain; Pain Threshold; Participant; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Physicians; Policies; Price; Primary Health Care; Procedures; Protocols documentation; Public Health; Randomized; Regulation; Relapse; Reporting; Research; Role; Safety; Sampling; Self Care; Severities; Site; Societies; Stress; Substance Use Disorder; System; Testing; Time; TimeLine; Training; Treatment Failure; Treatment outcome; United States; United States Substance Abuse and Mental Health Services Administration; Variant; Washington; addiction; base; behavior change; buprenorphine treatment; chronic pain; chronic pain patient; comorbidity; cost; craving; design; effectiveness evaluation; emotion dysregulation; emotion regulation; evidence base; illicit opioid; improved; medication-assisted treatment; mindfulness; mindfulness intervention; mortality; non-opioid analgesic; novel; opioid agonist therapy; opioid epidemic; opioid overdose; opioid use; opioid use disorder; pain sensitivity; physical symptom; prescription opioid; preventive intervention; primary outcome; programs; reduced substance use; relapse risk; response; secondary outcome; skills; substance use; treatment as usual; treatment comparison

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 leverages 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 two clinical settings funded through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, two-group, 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 health outcomes among patients receiving buprenorphine to treat OUD. The specific aims for the R21 portion are to solidify partnerships with proposed clinical program sites in order to develop a plan for implementing the study intervention and procedures, and to finalize study related documents necessary for the R33, including: study protocols, data collection and informed consent forms, intervention manuals and fidelity assessment checklists, training plans for research staff, data safety and monitoring plans. The first aim for the R33 portion is to evaluate the effectiveness of MABT + MAT compared to MAT only (treatment-as-usual) in reducing opioid use (primary outcome), opioid craving, MAT discontinuation, and non-opioid drug use (secondary outcomes) at the six-month time point. Aim 2 will examine the effectiveness of MABT + MAT for improving mental health distress (i.e. depression, anxiety, somatization, emotion regulation difficulties) compared to MAT only at 6 months. Aim 3 will explore the effectiveness of MABT + MAT compared to MAT only in reducing co-morbid pain severity and interference (Brief Pain Inventory) and pain sensitivity (cold pressor test). Results of this study will inform the evidence base for behavioral treatment adjuncts to MAT with buprenorphine and directly impact the future direction of the Washington Opioid STR program.

摘要 全国阿片类药物流行要求开发基于真实世界证据的阿片使用障碍治疗方法，包括丁丙诺啡药物辅助治疗(MAT)的辅助药物。需要采取干预措施，解决阿片类药物使用障碍患者的复杂需求，其中包括大量精神健康并存，以及与阿片类药物止痛处方和阿片类药物使用障碍复杂相互作用有关的高慢性疼痛发生率。这项研究利用最近的联邦和州阿片类药物使用障碍治疗倡议作为平台，测试一种有前途的心身干预措施，将身体定向治疗中的意识意识(MABT)作为MAT的辅助，在由华盛顿阿片类药物国家靶向反应(STR)计划资助的两个临床环境中进行。MABT是一种基于正念的新型干预措施，独特地解决了意识、内感和调节方面的问题，这些方面可能与增加复发风险和不良治疗结果的疼痛、心理健康困扰和行为控制有关。每个设置都采用了全国公认的马萨诸塞州护士护理经理模式的变体。使用随机、两组、重复测量设计，我们将比较接受MABT+MAT的患者和仅接受MAT的患者。该应用程序的首要目标是测试MABT，以改善接受丁丙诺啡治疗的患者的MAT健康结局。R21部分的具体目标是巩固与拟议临床项目站点的伙伴关系，以便制定实施研究干预和程序的计划，并最终确定R33所需的研究相关文件，包括：研究方案、数据收集和知情同意表、干预手册和保真度评估核对表、研究人员培训计划、数据安全和监测计划。R33部分的第一个目标是评估在六个月的时间点上，MABT+MAT与仅MAT(照常治疗)在减少阿片类药物使用(主要结果)、阿片类药物渴望、MAT停用和非阿片类药物使用(次要结果)方面的有效性。目的2比较MABT+MAT治疗6个月后对改善心理健康困扰(即抑郁、焦虑、躯体化、情绪调节困难)的效果。目的3探讨MABT+MAT与MAT相比仅在降低共病疼痛严重程度及干预(简明疼痛问卷)和疼痛敏感性(冷加压试验)方面的有效性。这项研究的结果将为行为治疗辅助药物与丁丙诺啡联合应用提供证据基础，并直接影响华盛顿阿片类药物STR计划的未来方向。

项目成果

A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder.

一项关于正念身体意识训练作为阿片类药物使用障碍办公室药物治疗辅助手段的试点研究。

• DOI: 10.1016/j.jsat.2019.05.013
• 发表时间: 2020
• 期刊: Journal of substance abuse treatment
• 影响因子: 3.9
• 作者: Price,CynthiaJ;Merrill,JosephO;McCarty,RachelleL;Pike,KennethC;Tsui,JudithI
• 通讯作者: Tsui,JudithI

Trauma Exposure Across the Lifespan among Individuals Engaged in Treatment with Medication for Opioid Use Disorder: Differences by Gender, PTSD Status, and Chronic Pain.

接受阿片类药物使用障碍药物治疗的个体一生中遭受的创伤：性别、创伤后应激障碍 (PTSD) 状态和慢性疼痛的差异。

• DOI: 10.21203/rs.3.rs-3750143/v1
• 发表时间: 2023
• 期刊: Research square
• 作者: Rodríguez,MoniqueN;Colgan,DanaD;Leyde,Sarah;Pike,Kenneth;Merrill,JosephO;Price,CynthiaJ
• 通讯作者: Price,CynthiaJ