Improving Sleep and Reducing Opioid Use in Individuals with Chronic Pain

改善慢性疼痛患者的睡眠并减少阿片类药物的使用

• 批准号: 10587972
• 负责人: Christina S McCrae
• 金额: $ 66.41万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10587972
• 关键词: 18 year old; Adult; Age; Arousal; Arrhythmia; Back; Behavioral; Brain; Cessation of life; Chronic; Chronic Insomnia; Cognitive; Cognitive Therapy; Community Healthcare; Data; Development; Education; Ethnic Origin; Evidence based intervention; Exhibits; Family; Healthcare; Hygiene; Individual; Inferior frontal gyrus; Insula of Reil; Intervention; Lead; Lentiform nucleus structure; Long-Term Effects; Mediator; Modeling; Musculoskeletal Pain; Neoadjuvant Therapy; Opioid; Opioid Analgesics; Outcome; Overdose; Pain; Pain Research; Pain management; Patients; Protocols documentation; Public Health; Race; Randomized; Relapse; Research; Research Priority; Severities; Sleep; Sleeplessness; Stimulus; Stress; Stress Tests; Testing; Urine; Withdrawal; Withdrawal Symptom; blood oxygen level dependent; brain abnormalities; central sensitization; chronic pain; chronic widespread pain; comorbidity; craving; experience; follow-up; heart rate variability; improved; improvement on sleep; novel; opioid tapering; opioid therapy; opioid use; opioid user; opioid withdrawal; pain processing; pain reduction; poor sleep; post intervention; prescription opioid; response; sex; theories; timeline; trial design

PROJECT SUMMARY Opioid therapy is commonly prescribed for patients with chronic widespread musculoskeletal pain, but offers questionable benefit for long-term pain management and is associated with arrhythmias, overdose, and death. Individuals with chronic pain experience high rates of comorbid chronic insomnia, arousal, and abnormal brain activation in response to painful stimuli. Research shows individuals with chronic pain exhibit increased brain activation in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids is difficult; and inadequately managed pain contributes to that difficulty. The Cognitive Activation Theory of Stress (CATS) tests the hypothesis that poor sleep and arousal lead to critical changes in brain activation that increase pain severity and lead to opioid use. Research shows cognitive behavioral treatment for insomnia (CBT-I, an evidence based intervention for chronic insomnia) improves sleep, arousal, abnormal brain activation, and pain in individuals with comorbid chronic pain and insomnia, but does not reduce opioid use. However, because CBT-I improves each of the mediators hypothesized to contribute to opioid use, it warrants examination as a neoadjuvant to gradual tapering of opioid medication. The proposed trial tests the novel hypothesis that improving sleep and decreasing arousal will lead to normalized brain activation and decreased pain prior to gradual tapering, which will facilitate reduced opioid use. This hypothesis is supported by theory (CATS) and empirical findings. It also reflects federal pain research priorities. Trial Design. 165 adults who use prescription opioid users (18+ years of age) and have chronic pain and insomnia will be randomized to CBT-I or Sleep Hygiene and Related Education (SHARE). They will then undergo a gradual tapered withdrawal protocol for opioids. Outcomes (sleep, arousal, brain activation, pain, opioid use, opioid related problems) will be examined at baseline (BL), post intervention (P1), post withdrawal (P2), and 6-month follow-up. Specific Aims 1 and 2 test the impact of CBT-I on sleep, arousal, brain activation, pain, opioid use, and opioid related problems compared to the active SHARE control. Specific Aims 3 and 4 test the impact of tapering opioid use following CBT-I on sleep, arousal, brain activation, pain, opioid use, and opioid related problems compared to the combined SHARE and tapered withdrawal control. An Exploratory Aim examines the relationships between changes in the mechanistic outcomes and changes in the opioid outcomes, and their potential moderators (e.g., craving, withdrawal symptoms, sex, age, race, ethnicity). Public Health Implications: Demonstration that a relatively brief behavioral sleep intervention facilitates tapered withdrawal from opioid medication and protects against relapse through improvements in sleep, arousal, abnormal brain activation, and pain has important implications for the millions of individuals living with chronic pain, their families, communities, and healthcare.

项目摘要 阿片类药物疗法通常针对患有慢性肌肉骨骼疼痛的患者处方，但可疑 长期疼痛管理的好处，与心律不齐，过量和死亡有关。患有慢性的人 疼痛的合并症慢性失眠，唤醒和脑激活异常的速度很高 刺激。研究表明，患有慢性疼痛的个体在与疼痛相关的区域表现出增加的大脑激活 与健康对照相比，对疼痛刺激的响应调节。从阿片类药物中提取很困难；和 管理不足的疼痛导致了这一困难。压力的认知激活理论（CAT）测试 假设睡眠不良和唤醒导致大脑激活的严重变化，从而增加了疼痛的严重程度并导致 阿片类药物使用。研究表明失眠的认知行为治疗（CBT-I，一种基于证据的慢性干预措施 失眠）改善了合并症慢性疼痛和 失眠，但不会减少阿片类药物的使用。但是，由于CBT-I改善了每个被认为的调解人 有助于阿片类药物的使用，值得检查作为新辅助治疗阿片类药物的逐渐缩小。提议 试验测试了一种新的假设，即改善睡眠和减少唤醒将导致大脑的归一化和 在逐渐变细之前减轻疼痛，这将有助于减少阿片类药物的使用。理论支持了这一假设 （猫）和经验发现。它还反映了联邦疼痛研究的重点。 试用设计。 165名使用处方阿片类药物使用者（18岁以上）并患有慢性疼痛和失眠的成年人将是 随机分为CBT-I或睡眠卫生和相关教育（共享）。然后，他们会经历逐渐锥形的 阿片类药物的提款方案。结局（睡眠，唤醒，大脑激活，疼痛，阿片类药物使用，阿片类药物相关的问题）将会 在基线（BL），干预后（P1），退出后（P2）和6个月的随访时进行检查。特定目标1和2 与该CBT-1的影响相比 主动共享控制。特定目的3和4测试CBT-I后CBT-I后逐渐使用阿片类药物对睡眠，唤醒， 与逐渐分配的戒断相比 控制。探索目的检查机械结果的变化与变化之间的关系 阿片类药物的结果及其潜在的主持人（例如，渴望，戒断症状，​​性别，年龄，种族，种族）。 公共卫生的影响：演示相对简短的行为睡眠干预有助于锥形 通过改善睡眠，唤醒，异常大脑的改善，从阿片类药物中提取并防止复发 激活和疼痛对数百万患有慢性疼痛的人，他们的家人， 社区和医疗保健。