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
基本信息
- 批准号:10587972
- 负责人:
- 金额:$ 66.41万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:18 year oldAdultAgeArousalArrhythmiaBackBehavioralBrainCessation of lifeChronicChronic InsomniaCognitiveCognitive TherapyCommunity HealthcareDataDevelopmentEducationEthnic OriginEvidence based interventionExhibitsFamilyHealthcareHygieneIndividualInferior frontal gyrusInsula of ReilInterventionLeadLentiform nucleus structureLong-Term EffectsMediatorModelingMusculoskeletal PainNeoadjuvant TherapyOpioidOpioid AnalgesicsOutcomeOverdosePainPain ResearchPain managementPatientsProtocols documentationPublic HealthRaceRandomizedRelapseResearchResearch PrioritySeveritiesSleepSleeplessnessStimulusStressStress TestsTestingUrineWithdrawalWithdrawal Symptomblood oxygen level dependentbrain abnormalitiescentral sensitizationchronic painchronic widespread paincomorbiditycravingexperiencefollow-upheart rate variabilityimprovedimprovement on sleepnovelopioid taperingopioid therapyopioid useopioid useropioid withdrawalpain processingpain reductionpoor sleeppost interventionprescription opioidresponsesextheoriestimelinetrial design
项目摘要
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Christina S McCrae其他文献
Christina S McCrae的其他文献
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{{ truncateString('Christina S McCrae', 18)}}的其他基金
Web-based CBT for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes
针对农村痴呆症护理人员失眠的基于网络的 CBT:睡眠、觉醒、情绪、认知和免疫结果的检查
- 批准号:
10610439 - 财政年份:2021
- 资助金额:
$ 66.41万 - 项目类别:
Contributions of Sleep and Pain to Alzheimer's Disease Related Biomarkers: Identifying Modifiable Risk Factors in Women with Normal to Mildly Impaired Cognitive Function
睡眠和疼痛对阿尔茨海默病相关生物标志物的影响:识别认知功能正常至轻度受损女性的可改变危险因素
- 批准号:
10289504 - 财政年份:2021
- 资助金额:
$ 66.41万 - 项目类别:
Web-based CBT for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes
针对农村痴呆症护理人员失眠的基于网络的 CBT:睡眠、觉醒、情绪、认知和免疫结果的检查
- 批准号:
10739134 - 财政年份:2021
- 资助金额:
$ 66.41万 - 项目类别:
Web-based CBT for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes
针对农村痴呆症护理人员失眠的基于网络的 CBT:睡眠、觉醒、情绪、认知和免疫结果的检查
- 批准号:
10428576 - 财政年份:2021
- 资助金额:
$ 66.41万 - 项目类别:
Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia.
CBT 治疗失眠对纤维肌痛疼痛症状和中枢敏化的影响。
- 批准号:
10163918 - 财政年份:2018
- 资助金额:
$ 66.41万 - 项目类别:
Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia.
CBT 治疗失眠对纤维肌痛疼痛症状和中枢敏化的影响。
- 批准号:
10414802 - 财政年份:2018
- 资助金额:
$ 66.41万 - 项目类别:
Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia.
CBT 治疗失眠对纤维肌痛疼痛症状和中枢敏化的影响。
- 批准号:
9769887 - 财政年份:2018
- 资助金额:
$ 66.41万 - 项目类别:
Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia.
CBT 治疗失眠对纤维肌痛疼痛症状和中枢敏化的影响。
- 批准号:
9927672 - 财政年份:2018
- 资助金额:
$ 66.41万 - 项目类别:
Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitizat
纤维肌痛的睡眠和疼痛干预:痛觉过敏和中枢敏化
- 批准号:
7941684 - 财政年份:2009
- 资助金额:
$ 66.41万 - 项目类别:
Sleep in Cardiac patients with Implantable Cardioverter Defibrillators (ICD)
使用植入式心脏复律除颤器 (ICD) 的心脏病患者的睡眠
- 批准号:
7839764 - 财政年份:2009
- 资助金额:
$ 66.41万 - 项目类别:
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