Pain and Opioid Dependence (POD)

疼痛和阿片类药物依赖 (POD)

基本信息

批准号：
7892325
负责人：
Richard S Schottenfeld
金额：
$ 36.53万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-07-15 至 2013-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7892325
关键词：
Abstinence Acute Admission activity Agonist Analgesics Anatomy Back Back Pain Behavior Behavior Therapy Behavioral Belief Breathing Buprenorphine Chronic Chronic low back pain Clinical Clinical Trials Cognitive Cognitive Therapy Complex Counseling Data Data Analyses Development Dose Drug usage Education Effectiveness Emotional Emotions Ensure Etiology Evaluation Exercise Frequencies Fright Goals Health Health Personnel Human Resources Illicit Drugs Individual Injury Intervention Life Style Lifting Low Back Pain Maintenance Manuals Mediator of activation protein Medical Modeling Movement Muscle Numeric Rating Scale Nurses Opiate Addiction Opiates Opioid Outcome Outcome Measure Pain Pain management Patients Personal Satisfaction Pharmaceutical Preparations Phase Physicians Population Posture Primary Health Care Procedures Process Psychologist Psychotherapy Randomized Randomized Clinical Trials Recovery Relapse Relaxation Relaxation Therapy Role Sample Size Sampling Severities Signal Transduction Social Functioning Staging Substance Use Disorder Techniques Thinking Training Treatment Efficacy Walking addiction base chronic pain cognitive control comparative efficacy coping craving effective therapy experience flexibility improved instrument lectures primary care setting primary outcome public health relevance secondary outcome skills visual imagery

项目摘要

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.

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 POD 认知行为治疗（CBT for POD），这种治疗方法可以由护士提供，患者可以接受，并且可以有效减少基于办公室的 BMT 中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，并且与 POD 患者最相关。这些模块包括： 1) 教育，为其他特定 CBT 模块提供基本原理； 2）认知控制，以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，以对抗失调并提高灵活性和社会功能； 4) 在不使用非法药物的情况下应对疼痛或渴望； 5) 放松训练。该 IB 阶段申请提出了心理治疗发展的 3 个阶段。在第一阶段，我们将培训2名心理学家和2名护士为POD提供手动引导的CBT，并培训2名心理学家和2名护士提供对比治疗（手动引导的教育咨询，EC），监督他们治疗各2个培训案例，并根据培训案例修改治疗手册。在第二阶段，我们将开展一项以办公室为基础的 BMT 试点随机临床试验 (RCT)，比较 CBT 对 POD 和 EC 的影响。 EC 在个别疗程的数量和频率上与 POD 的 CBT 相匹配，并使用教学讲座讨论的形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。经过 2 周的丁丙诺啡诱导/稳定治疗后，患有持续性非特异性腰痛（0-10 数字评分量表中疼痛等级为 e 4）的患者 (N=60) 将维持稳定的丁丙诺啡每日剂量，持续 12 周并随机分配到 POD 或 EC 的手动引导 CBT。主要结果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。次要结果指标包括治疗保留、非法阿片类药物连续戒断的最长持续时间以及情绪、身体和整体功能的改善。数据分析将重点关注所有随机患者的意向治疗样本，旨在评估 CBT 对 POD 和 EC 的结果差异的影响大小。在第三阶段，我们将对 POD 的 CBT 和 EC 手册和培训材料进行最终修订（如果需要），将临床实例纳入 POD 的 CBT 手册中，并确保培训程序关注不同的干预方式和技能组合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。如果研究结果支持 CBT 治疗 POD 的可行性和潜在功效，则有必要进行后续更大样本量的 II 期临床试验。公共健康相关性：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类激动剂维持治疗 (BMT)，为协调同时发生的慢性疼痛和阿片类药物依赖 (POD) 患者的成瘾和疼痛管理治疗提供了独特的机会），但与没有同时发生慢性疼痛的患者相比，POD 患者在 BMT 期间的治疗流失率更高，且持续非法阿片类药物使用水平更高。开发和评估有效的认知行为疗法，针对接受 BMT 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，并且可以按照本研究的计划，由初级保健或办公室护士提供，将有助于改善在基于办公室的 BMT 中治疗 POD。