Pain and Opioid Dependence (POD)

疼痛和阿片类药物依赖 (POD)

• 批准号: 8263984
• 负责人: Richard S Schottenfeld
• 金额: $ 34.92万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8263984
• 关键词: Abstinence; Acute Pain; Admission activity; Agonist; Alcohol or Other Drugs use; Analgesics; Anatomy; Back; Back Pain; Behavior; 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; Intention; 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 intensity; 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; 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; secondary outcome; skills; visual imagery

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 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.

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，会破坏 办公室丁丙诺啡维持治疗 (BMT) 的有效性。本申请建议 开发和评估 POD 的认知行为治疗（POD 的 CBT），该治疗对于 由护士提供，患者可以接受，并且可以有效减少患者的疼痛和药物使用结果 基于办公室的 BMT。 POD 的 CBT 基于 5 个 CBT 疼痛模块，具有最强有力的经验支持 非成瘾人群，与 POD 患者关系最为密切。这些模块包括：1) 教育为其他特定 CBT 模块提供基本原理； 2）认知控制来识别和 挑战功能失调的认知错误（例如灾难化）； 3) 锻炼和行为激活 对抗失调并增强灵活性和社会功能； 4) 不去应对痛苦或渴望 使用非法药物； 5) 放松训练。该 IB 阶段申请提出了 3 个阶段的心理治疗 发展。在第一阶段，我们将培训2名心理学家和2名护士，为患者提供人工指导的CBT POD和2名心理学家和2名护士提供对比治疗（手动引导 教育咨询，EC），监督他们各2个培训案例的治疗，并修改治疗方案 手册（如果根据培训案例指出）。在第二阶段，我们将进行试点随机临床 基于办公室的 BMT 试验 (RCT)，比较 POD 和 EC 的 CBT。 EC 与 POD 的 CBT 相匹配 个别课程的数量和频率，并使用教学讲座讨论的形式 向患者介绍有关背痛原因和治疗的核心主题（3 个模块）以及 阿片类药物成瘾和治疗（2 个模块）。经过两周的丁丙诺啡诱导/稳定后， 患有持续性非特异性腰痛的患者 (N=60)（0-10 数字评分量表上的疼痛评分为 e 4） 将维持稳定的每日丁丙诺平剂量 12 周，并随机分配至手动组 POD 或 EC 的引导 CBT。主要结果指标包括疼痛强度的减轻和 非法使用阿片类药物的频率（每周天数）。次要结果指标包括治疗保留、 连续戒除非法阿片类药物的最长持续时间，以及情绪、身体和精神方面的改善 全球运作。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 POD 和 EC 的 CBT 结果差异的效应大小。在 第三阶段，如果需要，我们将对 POD 和 EC 手册和培训材料的 CBT 进行最终修订， 将临床实例纳入 POD 手册中的 CBT，并确保培训程序符合 关注可能服务的不同专业人员的不同干预风格和技能组合 广泛的医疗环境中的患者。如果研究结果支持可行性和潜力 CBT 对 POD 的疗效，后续进行更大样本量的 II 期临床试验是有必要的。