NiteCAPP_HELPS_WD: Improving Sleep & Reducing Opioid Use in Chronic Pain

Status Active, not recruiting

Clinical Trial Summary

This project addresses the highly significant problem of developing effective strategies for facilitating withdrawal from opioid medications. The proposed work is conceptualized within the context of a well-known theoretical framework (Cognitive Activation Theory of Stress), and the research questions are theory-driven. The team proposes to evaluate an innovative web-based version of CBT-I followed by tapered withdrawal in a randomized trial in comparison to a Treatment As Usual control followed by tapered withdrawal. The dependent measures have been well-selected to effectively evaluate the outcomes. The methodological details are rigorous.

Clinical Trial Description

Individuals with chronic widespread pain are often prescribed opioid therapy. Unfortunately, opioid therapy offers questionable benefit for long-term pain management and is associated with other negative outcomes (arrhythmias, overdose, death). Individuals with chronic pain experience high rates of comorbid chronic insomnia, increased cognitive and physiological arousal, and disrupted executive function. They also often develop abnormal brain activation at rest and in response to painful stimuli (aka central sensitization). The investigator's research and other research shows individuals with chronic pain exhibit increased brain activation in the default mode network at rest and in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids can be difficult; and inadequately managed pain, abnormal brain activation, disrupted executive function, increased arousal, and poor sleep contribute to that difficulty. Consistent with the Cognitive Activation Theory of Stress (CATS), The investigators hypothesize that poor sleep and sustained arousal lead to critical changes in brain activation and disrupted executive function that increase pain and lead to opioid use. The proposed pilot will randomize 26 prescription opioid users who have chronic widespread pain and insomnia to 4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou) or treatment as usual. They will then complete a gradual tapered withdrawal protocol for opioids. ;

Study Design

Related Conditions & MeSH terms

Chronic Insomnia
Chronic Pain
Opioid Use
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT05226026
Study type	Interventional
Source	University of Missouri-Columbia
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 31, 2022
Completion date	December 15, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms