Yoga to Treat Chronic Pain in Persons Receiving Opioid Agonist Therapy

瑜伽可治疗接受阿片类激动剂治疗的患者的慢性疼痛

• 批准号: 9319211
• 负责人: Michael D Stein
• 金额: $ 21.55万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9319211
• 关键词: Adherence; Affective; Agonist; Alcohol or Other Drugs use; Alcohols; Anxiety; Behavioral Mechanisms; Benzodiazepines; Buprenorphine; Cognitive; Cognitive Therapy; Complement; Confidence Intervals; Control Groups; Data; Education; Educational Intervention; Enrollment; Feedback; Focus Groups; Fright; Health; Health education; Hyperalgesia; Illicit Drugs; Intervention; Maintenance; Manuals; Meditation; Mental Depression; Naloxone; Opiate Addiction; Opioid; Outcome; Pain; Pain management; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Phase; Physical activity; Population; Posture; Provider; Randomized Clinical Trials; Relaxation Therapy; Reporting; Research; Safety; Severities; Students; Training; Yoga; addiction; attentional control; base; chronic pain; disability; dosage; experience; follow-up; illicit drug use; improved; instructor; methadone maintenance; mindfulness; opiate tolerance; opioid misuse; opioid use disorder; patient population; pranayama; prevent; primary outcome; public health relevance; research and development; secondary outcome; substance abuser; therapy development

 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.

 描述(申请人提供)：慢性疼痛是接受阿片类药物依赖的阿片激动剂治疗(OAT)的一个严重问题，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、身体问题以及在这一人群中滥用阿片类药物或其他非法药物的可能性增加，往往导致提供者终止治疗。OAT患者的药理疼痛治疗因阿片类药物引起的痛敏、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在燕麦片治疗期间滥用阿片类药物的有益辅助方法。瑜伽集放松训练、体力活动和正念训练于一身。 瑜伽是治疗慢性疼痛的有前途的方法，因为：1)瑜伽有证据支持它可以减少其他人群中与疼痛相关的残疾和疼痛严重程度；2)有可信的认知/情感和行为机制，瑜伽可以减轻慢性疼痛，减少疼痛相关的残疾，和减少阿片类药物的滥用；3)瑜伽越来越普及；4)瑜伽可以补充其他类型的疼痛和物质使用治疗。我们建议进行治疗发展研究，使我们做好准备，研究瑜伽(与健康教育对照组相比)是否可能是一种有效的辅助治疗方法，用于治疗因阿片类药物使用障碍而参加OAT的患者的疼痛。我们假设，与对照组相比，瑜伽将：减少疼痛相关的残疾(主要结果)，减少疼痛，并减少阿片类药物的滥用。该项目将包括两个阶段。在第一阶段(治疗开发阶段1A)，我们将使用患者焦点小组(n=24名患者)和专家的反馈来改进我们目前的哈他瑜伽干预和健康教育干预，专门用于参加燕麦片治疗的慢性疼痛患者。在第二阶段(治疗发展阶段1B)，我们将对参加燕麦片治疗的慢性疼痛患者进行一项试点随机临床试验(n=60)，包括瑜伽和健康教育组(注意控制)。参与者将参加为期3个月的积极干预，然后进行为期6个月的跟踪调查。具体地说，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；评估两组在结果上的差异(在相关的可信区间内)；检查潜在作用机制的变化，包括正念、疼痛灾难、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这一系列研究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。哈达瑜伽有可能减少这一人群中与疼痛相关的残疾、疼痛严重程度和阿片类药物滥用。 治疗慢性疼痛。