Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Chronic Pain Clinical Trial

Official title: SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Chronic Insomnia
• Chronic Pain
• Opioid Use
• Sleep Initiation and Maintenance Disorders

• 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