Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

University of South Florida

Status: Enrolling

Conditions: Chronic Insomnia; Chronic Pain; Opioid Use

Treatments: Other: Tapered Withdrawal; Behavioral: CBT-I; Behavioral: Treatment as usual

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06345872

1R01DA054311 (U.S. NIH Grant/Contract)

STUDY005883

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 2 patient groups

Experimental

Experimental group

Description:

8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.

Treatment:

Behavioral: CBT-I

Other: Tapered Withdrawal

Treatment as usual

Other group

Description:

Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.

Treatment:

Behavioral: Treatment as usual

Other: Tapered Withdrawal