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.

项目总结 阿片类药物通常用于慢性广泛性肌肉骨骼疼痛的患者，但提供的效果值得怀疑。 有益于长期的疼痛管理，并与心律失常、过量用药和死亡有关。患有慢性病的个人 疼痛经历高比例的慢性失眠、觉醒和对疼痛的反应异常的大脑激活 刺激物。研究表明，慢性疼痛患者大脑中与疼痛相关的区域活动增强 与健康对照组相比，对疼痛刺激做出反应的调制。戒除阿片类药物很困难；以及 疼痛管理不当是造成这种困难的原因之一。压力的认知激活理论(CATS)测试 假设睡眠和性唤醒不良会导致大脑激活的严重变化，从而增加疼痛严重程度，并导致 阿片类药物的使用。研究表明认知行为治疗失眠(CBT-I)，一种基于证据的慢性干预 失眠)改善睡眠、觉醒、脑异常激活和疼痛，患有慢性疼痛和 失眠，但不减少阿片类药物的使用。然而，由于CBT-I改进了假设为 由于它有助于阿片类药物的使用，因此有理由将其作为逐步减少阿片类药物使用的新佐剂进行检查。建议数 试验测试了这一新的假设，即改善睡眠和减少觉醒将导致正常的大脑激活和 在逐步缩减之前减少疼痛，这将有助于减少阿片类药物的使用。这一假设得到了理论的支持 (CATS)和经验研究结果。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(18岁以上)并有慢性疼痛和失眠的成年人将被 随机参加CBT-I或睡眠卫生和相关教育(SHARE)。然后，它们将经历逐渐缩减的过程 阿片类药物的戒断方案。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)、停药后(P2)和6个月的随访时进行检查。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、 脑激活、疼痛、阿片类药物使用和阿片类药物相关问题与合并份额和逐渐戒断的比较 控制力。一个探索性的目的是考察机械性结果的变化和 阿片类药物的结果及其潜在的调节因素(例如，渴求、戒断症状、性别、年龄、种族、民族)。 公共健康影响：证明相对短暂的行为睡眠干预有助于逐渐减少睡眠 停用阿片类药物，通过改善睡眠、觉醒和异常大脑来防止复发 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。