Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
University of South Florida
165 participants
Dec 11, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- + 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 Criteria14
- 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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Interventions
Includes 8 weekly sessions of CBT-I and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
Includes 8 weekly sessions of standard treatment and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06345872