Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

在初级保健机构中治疗丁丙诺啡患者的慢性疼痛

• 批准号: 10561600
• 负责人: Michael D Stein
• 金额: $ 66.71万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-15 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10561600
• 关键词: Address; Affect; American; Attention; Behavior Therapy; Behavioral; Buprenorphine; Caring; Clinical; Cognitive Therapy; Collaborations; Data; Depressed mood; Fright; Goals; Health Care Costs; Health education; Individual; International; Intervention; Joints; Life; Measures; Medical; Mental Depression; Methadone; Nonpharmacologic Therapy; Nurses; Opiate Addiction; Opioid; Outcome; Pain; Pain interference; Pain management; Participant; Patient-Focused Outcomes; Patients; Persons; Pharmacotherapy; Phase; Physical activity; Population; Primary Care; Protocols documentation; Provider; Psychologist; Psychotherapy; Public Health; Randomized, Controlled Trials; Research; Research Design; Severities; Social Workers; Specialist; Testing; Treatment outcome; Work; acceptability and feasibility; addiction; behavioral health; buprenorphine treatment; chronic depression; chronic pain; chronic pain management; chronic pain patient; comorbidity; depressive symptoms; disability; improved; meetings; novel; opioid use disorder; pain outcome; pain reduction; pain relief; pain symptom; patients who use opioids; pharmacologic; prescription opioid; primary care provider; primary care setting; primary outcome; programs; psychosocial; randomized, clinical trials; recruit; relative cost; secondary outcome; substance use; substance use treatment; symptom treatment; targeted treatment; treatment planning

ABSTRACT Nearly half a million Americans receive buprenorphine for opioid use disorder (OUD). More than 40% of those seeking treatment with buprenorphine have pain that interferes with daily activities and affects drug treatment outcomes, yet no effective non-pharmacological therapies exist to improve pain outcomes. Developing a novel pain treatment is complicated by the fact that among opioid dependent patients, pain often co-occurs with depression. We developed a collaborative primary care approach, entitled TOPPS (Treating Opioid Patients’ Pain and Sadness), in which behavioral health specialists and primary care providers share a unified plan for addressing pain and depression in patients receiving buprenorphine. The newly developed intervention integrates and builds upon behavior therapy for chronic pain and depression with the aim of reducing behavioral avoidance and increasing behavioral activation. In our pilot work, we demonstrated that TOPPS meets standards of feasibility and preliminary efficacy and, building on our R34 findings, we now propose a randomized controlled trial of TOPPS compared to a health education contact-control condition among 250 persons with OUD recruited from two primary care-based buprenorphine programs. We will provide both interventions over three months and follow participants for a total of 12 months in order to observe both short- term and longer-term effects of TOPPS. P ain-related interference with physical and psychosocial functioning (“pain interference”), pain severity and depression will be the primary outcome variables assessed, and buprenorphine treatment retention will be the secondary outcome variable. Our goal is for this research to result in the incorporation into buprenorphine care of theoretically-driven, empirically-tested therapy for patients with pain and depressive symptoms. We believe that TOPPS will lead to improved pain, depression, and substance use outcomes, and can utilize providers available within buprenorphine programs, broadening the disseminability of this novel intervention and heightening its public health impact nationally and internationally.

摘要 近50万美国人接受丁丙诺啡治疗阿片类药物使用障碍（OUD）。其中超过40%的人 寻求丁丙诺啡治疗的患者疼痛会干扰日常活动并影响药物治疗 结果，但没有有效的非药物治疗存在，以改善疼痛的结果。开发一部小说 疼痛治疗因以下事实而复杂化：在阿片类药物依赖患者中，疼痛常常与 萧条我们开发了一种合作的初级保健方法，名为TOPPS（治疗阿片类药物患者）， 疼痛和悲伤），其中行为健康专家和初级保健提供者共享一个统一的计划， 治疗接受丁丙诺啡的患者的疼痛和抑郁。新开发的干预措施 整合并建立在慢性疼痛和抑郁症的行为疗法的基础上，目的是减少 行为回避和增加行为激活。在我们的试点工作中，我们证明了TOPPS 符合可行性和初步有效性的标准，基于我们的R34研究结果，我们现在提出一项 在250名受试者中进行的TOPPS与健康教育接触对照条件比较的随机对照试验 从两个基于初级保健的丁丙诺啡项目招募的OUD患者。我们将提供两者 干预超过三个月，并跟踪参与者共12个月，以观察两个短期- TOPPS的长期和长期影响。P 因相关 干扰身体和心理社会功能 （“疼痛干扰”）、疼痛严重程度和抑郁将是评估的主要结局变量， 丁丙诺啡治疗保留率将是次要结果变量。我们的目标是让这项研究 导致在丁丙诺啡治疗中纳入理论驱动的、经过临床试验的患者治疗 伴有疼痛和抑郁症状。我们相信，TOPPS将导致改善疼痛，抑郁， 物质使用结果，并可以利用丁丙诺啡计划内的提供者，扩大 这一新的干预措施的传播，并提高其在国内和国际上的公共卫生影响。