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.

共同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， 基于办公室的丁丙诺啡维持治疗（BMT）的有效性。本申请建议 开发和评估一种对POD的认知行为治疗（CBT for POD）， 由护士提供，患者可接受，有效减少疼痛和药物使用结局， 办公室BMT POD的CBT基于5个CBT疼痛模块，具有最强的经验支持， 非成瘾人群，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，灾难化）; 3）运动和行为激活， 对抗失调，增加灵活性和社会功能; 4）应对疼痛或渴望， （5）放松训练。这个阶段IB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 POD和2名心理学家和2名护士提供比较治疗（手册指导 教育咨询，EC），监督他们每个2个培训案例的治疗，并修改治疗方法 手册，如果根据培训案例进行说明。在第二阶段，我们将进行一项试点随机临床试验， 基于办公室的BMT试验（RCT）比较POD和EC的CBT。EC与POD的CBT匹配， 个别会议的数量和频率，并使用教学讲座讨论格式， 教育患者关于背痛原因和治疗的核心主题（3个模块）， 阿片类药物成瘾和治疗（2个模块）。在2周丁丙诺啡诱导/稳定后， 持续性非特异性腰痛患者（N=60）（0-10数字评分量表上疼痛评分e4） 将维持稳定的每日丁丙诺平剂量12周，并随机分配至手动- 引导CBT用于POD或EC。主要结果指标包括疼痛强度的降低和 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率， 连续戒断非法阿片类药物的最长时间，以及情绪、身体和 全球功能。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的CBT之间结局差异的效应量。在 第3阶段，我们将根据需要对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手册的CBT中，并确保培训程序 注意不同的干预风格和不同专业人员的技能， 在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， 为了确定CBT对POD的有效性，需要进行后续的II期临床试验，样本量更大。