Yoga to Treat Chronic Pain in Persons Receiving Opioid Agonist Therapy

 描述（由申请人提供）：慢性疼痛是接受阿片类药物激动剂治疗（OAT）治疗阿片类药物依赖的人的一个重要问题-即，丁丙诺啡/纳洛酮（BUP）和美沙酮维持治疗（MMT）。接受BUP和MMT治疗的患者中至少有一半患有慢性疼痛。慢性疼痛与疼痛相关的残疾，精神问题，身体问题以及滥用阿片类药物或其他非法药物的可能性增加有关，通常导致提供者终止治疗。OAT患者的药物疼痛治疗因阿片类药物诱导的痛觉过敏、阿片类药物耐受性增加、其他物质使用以及患者自身对药物和成瘾的恐惧等问题而变得复杂。哈达瑜伽可能是治疗慢性疼痛，减少疼痛相关残疾和防止OAT期间阿片类药物滥用的有益方法。瑜伽包括放松训练，身体活动和正念训练的好处。 瑜伽是治疗OAT患者慢性疼痛的一种很有前途的方法，因为：1）瑜伽有证据支持其在其他人群中减少疼痛相关残疾和疼痛严重程度的能力; 2）有合理的认知/情感和行为机制，瑜伽可以减少慢性疼痛，减少疼痛相关残疾，并减少阿片类药物滥用; 3）瑜伽越来越可用。4）瑜伽可以补充其他类型的疼痛和物质使用治疗。我们建议进行治疗开发研究，使我们能够研究瑜伽（与健康教育对照组相比）是否可能是治疗阿片类药物使用障碍OAT患者疼痛的有效治疗方法。我们假设，相对于对照组，瑜伽将：减少疼痛相关的残疾（主要结果），减少疼痛，减少阿片类药物滥用。该项目将包括两个阶段。在第1阶段（治疗开发阶段1A），我们将使用来自患者焦点小组（n= 24例患者）和专家的反馈来完善我们目前的哈他瑜伽干预和健康教育干预，以专门用于OAT慢性疼痛患者。在第2阶段（治疗开发阶段1B），我们将对参加OAT的慢性疼痛患者进行一项试验性随机临床试验（n = 60），比较瑜伽与健康教育组（注意力控制）。受试者将参加3个月的积极干预，然后随访6个月。具体来说，我们将评估积极干预组和对照组的可行性、可接受性和安全性;评估各组之间的结果差异（在相关置信区间内）;检查潜在作用机制的变化，包括正念、疼痛灾难化、抑郁和焦虑;并检查瑜伽练习的量（“剂量”）是否与关键结果相关。该项目将为我们提供该研究线下一阶段所需的材料、经验和试点数据，即完全有效的随机临床试验。哈他瑜伽有可能减少疼痛相关的残疾，疼痛的严重程度和阿片类药物滥用，在这一人群中， 治疗慢性疼痛。

 DESCRIPTION (provided by applicant): Chronic pain is a significant problem for people receiving opioid agonist therapy (OAT) for opioid dependence - i.e., buprenorphine/ naloxone (BUP) and methadone maintenance treatment (MMT). At least half of patients receiving BUP and MMT have chronic pain. Chronic pain is associated with pain-related disability, psychiatric problems, physical problems, and increased likelihood of misuse of opioids or other illicit drugs in this population, often leading providers to terminate treatment. Pharmacologic pain treatment in OAT patients is complicated by issues such as opioid-induced hyperalgesia, increased tolerance of opioids, other substance use, and patients' own fears about medications and addiction. Hatha yoga may be a beneficial adjunctive approach to treating chronic pain, decreasing pain-related disability, and preventing opioid misuse during OAT. Yoga includes benefits of relaxation training, physical activity, and mindfulness training in a unified practice. Yoga is a promising approach for treating chronic pain in people enrolled in OAT because: 1) yoga has evidence supporting its ability to reduce pain-related disability and pain severity in other populations; 2) there are plausible cognitive/affective and behavioral mechanisms by which yoga may reduce chronic pain, decrease pain-related disability, and reduce opioid misuse; 3) yoga is increasingly available; and 4) yoga can complement other types of pain and substance use treatment. We propose to conduct treatment development research that would prepare us to study whether yoga (vs. a health education control group) might be an effective adjunctive treatment for pain in people enrolled in OAT for opioid use disorders. We hypothesize that, relative to a control group, yoga will: decrease pain-related disability (primary outcome), decrease pain, and decrease opioid misuse. This project will include two phases. In phase 1 (Treatment Development Stage 1A), we will use feedback from patient focus groups (n= 24 patients) and experts to refine our current hatha yoga intervention and health education intervention for specific use in people enrolled in OAT with chronic pain. In phase 2 (Treatment Development Stage 1B), we will conduct a pilot randomized clinical trial (n = 60) of yoga vs. health education groups (attention control) for persons with chronic pain who enrolled in OAT. Participants will be enrolled in the active intervention for 3 months, and then be followed for 6 months. Specifically, we will assess feasibility, acceptability, and safety of both the active intervention and control groups; assess differences between groups on outcomes (within relevant confidence intervals); examine changes on potential mechanisms of action, including mindfulness, pain catastrophizing, depression, and anxiety; and examine whether amount ("dosage") of yoga practice is related to key outcomes. This project will provide us with materials, experience, and pilot data necessary for the next stage of this line of research, namely, a fully powered randomized clinical trial. Hatha yoga has a potential to decrease pain-related disability, pain severity, and opioid misuse in this population of people with difficult-to treat chronic pain.