Clinical trial NCT05226026: NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients
Official title: Impact of Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain on Central Pain Processing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pain
Chronic Insomnia
Opioid Use
Keywords: Tapered withdrawal
NiteCAPP
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 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 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

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Pain Intensity - Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Sleep Efficiency- Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Fatigue - Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Perceived Stress Scale
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Peripheral Arousal
timeFrame: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Pain Catastrophizing Scale
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Thermal Pain Response
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Opioid Use (Quantitative)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Opioid Use (Self-Report)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Secondary outcomes:
measure: Change in State-Trait Anxiety Inventory (STAI)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Depression (Beck Depression Inventory-II)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in 36-Item Short Form Survey (SF-36)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Objective Wake After Sleep Onset (Actigraph)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Objective Sleep Onset Latency (Actigraph)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in Objective Sleep Efficiently (Actigraph)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in NIH Toolbox
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
measure: Change in non-opioid substance use
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Other outcomes:
measure: Satisfaction Survey
timeFrame: Single administration at post-treatment - 8 weeks, following completion of gradual tapered withdrawal
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
References: