Pain and Opioid Dependence (POD)

描述（由申请人提供）：同时发生的慢性疼痛和阿片类药物依赖（POD）是一个具有挑战性的临床问题，它破坏了基于办公室的丁丙诺啡维持治疗（BMT）的有效性。本申请旨在开发和评估一种认知行为治疗POD （CBT for POD）的方法，该方法应由护士提供，患者可接受，并能有效减少办公室BMT的疼痛和药物使用结果。POD的CBT基于5个CBT疼痛模块，在非成瘾人群中具有最强的经验支持，与POD患者最相关。这些模块包括：1)为其他特定的CBT模块提供基本原理的教育；2)认知控制，识别和挑战功能失调的认知错误（例如，灾难化）；3)锻炼和行为激活，以对抗去条件化，增加灵活性和社会功能；4)能忍受痛苦或渴望，不吸毒；5)放松训练。这个IB阶段的申请提出了心理治疗发展的三个阶段。在第一阶段，我们将培训2名心理咨询师和2名护士为POD提供手册指导CBT，培训2名心理咨询师和2名护士提供对照治疗（手册指导教育咨询，EC），并监督他们各自治疗2个培训案例，根据培训案例需要修改治疗手册。在第二阶段，我们将进行一项基于办公室的BMT的随机临床试验（RCT），比较CBT治疗POD和EC的效果。EC在治疗POD的次数和频率上与CBT相匹配，并采用说教式讲座-讨论的形式来教育患者关于背部疼痛的原因和治疗（3个模块）以及阿片类药物成瘾和治疗（2个模块）的核心主题。在2周丁丙诺啡诱导/稳定治疗后，患有持续性非特异性腰痛（疼痛等级在0-10数值评定量表中为4级）的患者（N=60）将在12周内维持稳定的每日丁丙诺啡剂量，并随机分配给POD或EC的手动引导CBT。主要结局指标包括疼痛强度和非法阿片类药物使用频率（每周天数）的减少。次要结局指标包括治疗保持，最长时间连续戒断非法阿片类药物，以及情绪、身体和整体功能的改善。数据分析将集中在所有随机患者的意向治疗样本上，旨在评估CBT治疗POD和EC之间结果差异的效应大小。在第三阶段，我们将对POD和EC的CBT手册和培训材料进行最终修订，如果需要的话，将临床实例纳入POD的CBT手册，并确保培训程序注意到可能在各种医疗环境中为患者服务的不同专业人员的不同干预风格和技能。如果研究结果支持CBT治疗POD的可行性和潜在疗效，那么后续的II期临床试验将需要更大的样本量。

DESCRIPTION (provided by applicant): Co-occurring chronic pain and opioid dependence (POD) is a challenging clinical problem that undermines the effectiveness of office-based buprenorphine maintenance treatment (BMT). This application proposes to develop and evaluate a cognitive-behavioral treatment for POD (CBT for POD) that would be feasible to provide by nurses, acceptable to patients, and efficacious for reducing pain and drug use outcomes in office-based BMT. CBT for POD is based on 5 CBT pain modules with the strongest empirical support in non-addict populations and of greatest relevance to patients with POD. These modules include: 1) Education to provide a rationale for the other specific CBT modules; 2) Cognitive Control to identify and challenge dysfunctional cognitive errors (e.g., catastrophizing); 3) Exercise and Behavioral Activation to counter deconditioning and increase flexibility and social functioning; 4) Coping with Pain or Craving without illicit drug use; and 5) Relaxation Training. This Stage IB application proposes 3 phases of psychotherapy development. In Phase 1, we will train 2 psychologists and 2 nurses to provide manual-guided CBT for POD and 2 psychologists and 2 nurses to provide the comparison treatment (manual-guided Educational Counseling, EC), supervise their treatment of 2 training cases each, and revise the therapy manuals, if indicated based on the training cases. In Phase 2, we will conduct a pilot randomized clinical trial (RCT) of office-based BMT comparing CBT for POD and EC. EC is matched to CBT for POD in number and frequency of individual sessions and uses a didactic lecture-discussion format to educate the patient about core topics about back pain causes and treatments (3 modules) and opioid addiction and treatment (2 modules). Following a 2-week buprenorphine induction/stabilization, patients (N=60) with persistent non-specific low back pain (pain ratings e 4 on a 0-10 numeric rating scale) will be maintained on a stable daily buprenorpine dose for 12 weeks and randomly assigned to manual- guided CBT for POD or EC. Primary outcome measures include reductions in pain intensity and in frequency (days per week) of illicit opioid use. Secondary outcome measures include treatment retention, longest duration of consecutive abstinence from illicit opioids, and improvement in emotional, physical and global functioning. Data analyses will focus on an intention-to-treat sample of all randomized patients and are intended to evaluate the effect size of the differences in outcomes between CBT for POD and EC. In Phase 3, we will make final revisions of the CBT for POD and EC manuals and training materials, if needed, incorporate clinical examples in the CBT for POD manual, and ensure that the training procedures are attentive to the different intervention styles and skill sets of different professionals who might be serving patients in a broad range of medical settings. If the study findings support the feasibility and potential efficacy of CBT for POD, a subsequent Stage II clinical trial with a larger sample size would be warranted. PUBLIC HEALTH RELEVANCE: The recent introduction of physician-prescribed buprenorphine for opioid agonist maintenance treatment (BMT) in office-based medical settings provides a unique opportunity to coordinate addiction and pain management treatment for patients with co-occurring chronic pain and opioid dependence (POD), but patients with POD have greater treatment attrition and higher levels of continuing illicit opioid use during BMT than patients without co-occurring chronic pain. Development and evaluation of an effective cognitive-behavioral therapy that targets the interrelated problems of pain and opioid dependence for patients with POD treated with BMT and that could be provided by primary care or office-based nurses, as planned in this study, would facilitate improved treatment for POD in office-based BMT.