Improving Sleep and Reducing Opioid Use in Individuals with Chronic Pain

项目摘要 阿片类药物治疗通常用于慢性广泛性肌肉骨骼疼痛患者，但其疗效值得怀疑。 有利于长期疼痛管理，并与心律失常，过量和死亡有关。慢性病患者 疼痛经历高比率的共病慢性失眠，觉醒，以及对疼痛的反应的异常大脑激活。 刺激。研究表明，患有慢性疼痛的人在与疼痛相关的区域表现出增加的大脑激活 与健康对照组相比，疼痛刺激的反应调制。阿片类药物戒断困难; 对疼痛的不适当管理导致了这种困难。压力的认知激活理论（CATS）测试了 假设睡眠和觉醒不良导致大脑激活的关键变化，增加疼痛的严重程度，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失眠干预方法） 失眠）改善睡眠、觉醒、异常脑激活和患有慢性疼痛的个体的疼痛， 失眠，但不会减少阿片类药物的使用。然而，由于CBT-I改善了假设的每种介质， 虽然它有助于阿片类药物的使用，但它值得作为阿片类药物逐渐减量的新辅助剂进行检查。拟议 一项试验测试了一个新的假设，即改善睡眠和减少觉醒将导致正常的大脑激活， 在逐渐减量之前减少疼痛，这将有助于减少阿片类药物的使用。这一假设有理论支持 （CATS）和实证研究结果。它也反映了联邦疼痛研究的优先事项。 试验设计。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 随机分配至CBT-I或睡眠卫生和相关教育组（SHARE）。然后，他们将经历一个渐进的锥形 阿片类药物戒断方案结果（睡眠、觉醒、大脑激活、疼痛、阿片类药物使用、阿片类药物相关问题）将 在基线（BL）、干预后（P1）、退出后（P2）和6个月随访时进行检查。具体目标1和2 测试CBT-I对睡眠，觉醒，大脑激活，疼痛，阿片类药物使用和阿片类药物相关问题的影响， 主动共享控制。具体目标3和4测试CBT-I后逐渐减少阿片类药物使用对睡眠，觉醒， 与联合SHARE和逐渐戒断相比，大脑激活、疼痛、阿片类药物使用和阿片类药物相关问题 控制探索性目标考察了机械结果变化与 阿片样物质的结果，及其潜在的调节剂（例如，渴望、戒断症状、性别、年龄、种族、民族）。 公共卫生意义：证明相对短暂的行为睡眠干预有助于逐渐减少 从阿片类药物中戒断，并通过改善睡眠，唤醒，异常大脑 激活，疼痛对数百万慢性疼痛患者，他们的家人， 社区和医疗保健。

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.