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Clinical Trial Summary

The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06345872
Study type Interventional
Source University of South Florida
Contact Christina S McCrae, PhD
Phone (813) 974-1804
Email christinamccrae@usf.edu
Status Recruiting
Phase N/A
Start date April 2024
Completion date July 2028

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