Status:
WITHDRAWN
NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Chronic Pain
Chronic Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed 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 negat...
Eligibility Criteria
Inclusion
- 18+ yrs old
- willing to be randomized
- can read/understand English
- diagnosed with chronic widespread pain and insomnia
- 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 for 6+ wks.
Exclusion
- 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 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 current 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
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05226026
Start Date
March 31 2022
End Date
June 1 2024
Last Update
August 5 2024
Active Locations (1)
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1
University of Missouri-Columbia
Columbia, Missouri, United States, 65201