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，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价一种POD的认知行为治疗（POD的CBT），该治疗可由护士提供，患者可接受，并可有效减少基于办公室的BMT中的疼痛和药物使用结局。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患者的相关性最大。这些模块包括：1）教育，为其他具体的CBT模块提供理论基础; 2）认知控制，以识别和挑战功能失调的认知错误（例如，catastrophizing）; 3）运动和行为激活，以对抗失调，增加灵活性和社会功能; 4）应对疼痛或渴望，而不使用非法药物;和5）放松训练。这个阶段IB申请提出了心理治疗发展的3个阶段。在第1阶段，我们将培训2名心理学家和2名护士，为POD提供手册指导的CBT，并培训2名心理学家和2名护士提供比较治疗（手册指导的教育咨询，EC），监督他们对2个培训案例的治疗，并根据培训案例修改治疗手册（如有必要）。在第2阶段，我们将进行一项基于办公室的BMT的试点随机临床试验（RCT），比较POD和EC的CBT。EC在个别会议的数量和频率方面与POD的CBT相匹配，并使用教学式讲座讨论格式来教育患者有关背痛原因和治疗（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/稳定后，患有持续性非特异性下背痛（0-10数字评定量表上的疼痛评级e4）的患者（N=60）将维持稳定的每日丁丙诺啡剂量12周，并随机分配至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）的降低。次要结局指标包括治疗保留、连续戒断非法阿片类药物的最长持续时间以及情感、身体和整体功能的改善。数据分析将侧重于所有随机化患者的意向治疗样本，旨在评估POD和EC CBT之间结局差异的效应量。在第3阶段，我们将对POD CBT和EC手册和培训材料进行最终修订（如需要），在POD CBT手册中纳入临床示例，并确保培训程序关注可能在广泛的医疗环境中为患者提供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，则需要进行后续的II期临床试验，样本量更大。 公共卫生相关性：最近在基于办公室的医疗环境中引入医生处方的丁丙诺啡用于阿片类激动剂维持治疗（BMT），为协调慢性疼痛和阿片类药物依赖（POD）并存患者的成瘾和疼痛管理治疗提供了一个独特的机会，但POD患者在BMT期间的治疗损耗和持续非法阿片类药物使用水平高于未同时发生慢性疼痛的患者。开发和评估一种有效的认知行为疗法，针对BMT治疗POD患者的疼痛和阿片类药物依赖的相关问题，并可由初级保健或办公室护士提供，如本研究所计划的那样，将有助于改善办公室BMT中POD的治疗。

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.