Pain and Opioid Dependence (POD)

描述(由申请人提供)：慢性疼痛和阿片类药物依赖(POD)共同出现是一个具有挑战性的临床问题，破坏了办公室丁丙诺啡维持治疗(BMT)的有效性。这项申请建议开发和评估POD的认知行为疗法(CBT For POD)，该疗法将由护士提供可行，患者可以接受，并有效地减少办公室BMT中的疼痛和药物使用结果。用于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，并且与POD患者的相关性最大。这些单元包括：1)为其他具体的CBT模块提供理论基础的教育；2)识别和挑战功能失调的认知错误(例如，灾难)的认知控制；3)运动和行为激活，以对抗去条件反射，增加灵活性和社会功能；4)在不使用非法药物的情况下应对疼痛或渴望；以及5)放松培训。这一阶段的IB应用提出了心理治疗发展的三个阶段。在第一阶段，我们会培训2名心理学家和2名护士，为儿童功能障碍提供手导式CBT，以及培训2名心理学家和2名护士，提供对照治疗(手导式教育辅导，EC)，监督他们每人治疗2个培训案例，并根据培训案例修改治疗手册。在第二阶段，我们将进行一项基于Office的BMT的试点随机临床试验(RCT)，比较CBT对POD和EC的疗效。EC在个别课程的次数和频率上与CBT的POD相匹配，并使用授课-讨论的形式来教育患者关于背痛原因和治疗(3个模块)以及阿片成瘾和治疗(2个模块)的核心主题。在丁丙诺啡诱导/稳定2周后，60名患有持续性非特异性下腰痛(疼痛评分e 4，数字评分0-10)的患者将被维持每天稳定的丁丙诺平剂量12周，并随机分配到手动引导的CBT治疗POD或EC。主要结果衡量标准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。次要结果衡量标准包括继续接受治疗、连续戒除非法阿片类药物的最长时间以及情绪、身体和全球功能的改善。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对POD和EC结果差异的影响大小。在第三阶段，如有需要，我们将最后修订CBT的POD和EC手册和培训材料，将临床实例纳入CBT for POD手册，并确保培训程序关注可能在广泛的医疗环境中为患者服务的不同专业人员的不同干预方式和技能。如果研究结果支持CBT治疗POD的可行性和潜在疗效，将有理由进行后续的II期临床试验，样本量更大。 公共卫生相关性：最近在办公室医疗环境中引入医生处方的丁丙诺啡用于阿片激动剂维持治疗(BMT)，为同时存在慢性疼痛和阿片依赖(POD)的患者提供了一个协调成瘾和疼痛管理治疗的独特机会，但POD患者在BMT期间有更多的治疗磨耗和更高的非法阿片类药物持续使用水平。开发和评估一种有效的认知行为疗法，针对接受骨髓移植治疗的POD患者的疼痛和阿片类药物依赖等相互关联的问题，并可由初级保健或办公室护士提供，如本研究所计划的，将有助于改善办公室骨髓移植中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.