Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Pain; Opioid Use; Chronic Insomnia
• Interventions: Behavioral: CBT-I; Behavioral: Treatment as usual; Other: Tapered Withdrawal

• Registration Number: NCT06345872
• Lead Sponsor: University of South Florida

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Posted: 2024-04-03
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2028-01
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• 18+ yrs
• willing to be randomized,
• can read/understand English
• diagnosed with chronic widespread pain and insomnia (as described below)
• prescribed opioid medication for 1+ mo, 3+ times per week
• desire to reduce or eliminate opioid use
• written agreement from physician prescribing opioid medication
• no prescribed or OTC sleep meds for 1+ mo, or stabilized on meds for 6+ wks

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Exclusion Criteria

• unable to provide informed consent
• cognitive impairment (MMSE <26)
• sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15)
• Periodic Limb Movement Disorder (myoclonus arousals per hour >15)]
• bipolar or seizure disorder (due to risk of sleep restriction treatment)
• other severe, untreated major psychopathology except for depression or anxiety (e.g.,suicidal ideation/intent, psychotic disorders)
• psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep (medications prescribed for pain or sleep are allowed)
• participation in other non-pharmacological treatment for pain, sleep, or mood outside the current trial
• internal metal objects or electrical devices
• pregnancy
• presumptive/confirmed lumbar nerve root compression
• confirmed lumbar spinal stenosis
• <6 mos post-back surgery
• other spinal disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	CBT-I	8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
Experimental	Tapered Withdrawal	8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
Treatment as usual	Treatment as usual	Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.
Treatment as usual	Tapered Withdrawal	Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.

Primary Outcome Measures

Name	Time	Method
Change in Sleep Efficiency- Daily Electronic Sleep Diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Daily electronic dairies will record sleep efficiency
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Daily electronic dairies will record daily medication consumption)
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Daily electronic dairies will record sleep onset latency (number of minutes)
Change in Perceived Stress Scale	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Perception of stress; score range: 0-40 (low stress - high stress)
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Assessment of neural plasticity
Change in Opioid Use (Quantitative)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Change in opioid use assessed with quantitative urine opioid panel
Change in Thermal Pain Response	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)
Change in Insomnia Severity Index	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Insomnia severity; score range 0-28 (low severity - high severity)
Change in Pain Intensity - Daily Electronic Sleep Diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Daily electronic dairies will record wake after sleep onset (number of minutes)
Change in Fatigue - Daily Electronic Sleep Diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Change in Peripheral Arousal	5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Heart Rate Variability (as measured by Holter-Monitoring)
Change in Opioid Use (Self-Report)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Change in opioid use assessed with daily electronic diaries

Secondary Outcome Measures

Name	Time	Method
Short Inventory of Problems	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Modified from validated alcohol survey for opioid related problems
Change in Objective Sleep Onset Latency (Actigraph)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Sleep Onset Latency via GENEActiv
Change in Objective Sleep Efficiency (Actigraph)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Sleep Efficiency via GENEActiv
Change in Pain Catastrophizing Scale	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score range from 0-52, with higher scores indicating greater pain catastrophizing.
Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Assessment of brain connectivity
Change in Objective Wake After Sleep Onset (Actigraph)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up	Wake after sleep onset via GENEActiv

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States