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