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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou)
Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.
University of Missouri-Columbia
Columbia, Missouri, United States
Change in Insomnia Severity Index
Insomnia severity; score range 0-28 (low severity - high severity)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Intensity - Daily Electronic Sleep Diaries
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Daily electronic dairies will record wake after sleep onset (number of minutes)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep onset latency (number of minutes)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep efficiency
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Fatigue - Daily Electronic Sleep Diaries
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
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Daily electronic dairies will record daily medication consumption
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Perceived Stress Scale
Perception of stress; score range: 0-40 (low stress - high stress)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Peripheral Arousal
Heart Rate Variability (as measured by Holter-Monitoring)
Time frame: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Catastrophizing Scale
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.
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
assessment of neural plasticity
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Thermal Pain Response
Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Quantitative)
Change in opioid use assessed with quantitative urine opioid panel
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Self-Report)
Change in opioid use assessed with daily electronic diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in State-Trait Anxiety Inventory (STAI)
Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Depression (Beck Depression Inventory-II)
Depression severity; score range: 0-63 (normal - extreme depression)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in 36-Item Short Form Survey (SF-36)
Self-reported health; score range: low quality of life to high quality of life
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Wake After Sleep Onset (Actigraph)
Wake after sleep onset via Actiwatch-2
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Sleep Onset Latency (Actigraph)
Sleep Onset Latency via Actiwatch-2
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Sleep Efficiently (Actigraph)
Sleep Efficiency via Actiwatch-2
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in NIH Toolbox
20 minute computerized cognitive tasks
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in non-opioid substance use
self reported changes in non-opioid substances via electronic diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal