Impact of Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain on Central Pain Processing
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
NiteCAPP HELPS
4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
干预措施: NiteCAPP HELPS (Behavioral)
NiteCAPP HELPS
4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
干预措施: Tapered Withdrawal (Other)
Treatment as Usual
Continuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.
干预措施: Tapered Withdrawal (Other)
结局指标
主要结局
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
assessment of neural plasticity
Change in Insomnia Severity Index
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Insomnia severity; score range 0-28 (low severity - high severity)
Change in Pain Intensity - Daily Electronic Sleep Diaries
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Change in Fatigue - Daily Electronic Sleep Diaries
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Change in Pain Catastrophizing Scale
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
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.
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record sleep onset latency (number of minutes)
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record sleep efficiency
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record daily medication consumption
Change in Thermal Pain Response
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record wake after sleep onset (number of minutes)
Change in Peripheral Arousal
时间窗: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Heart Rate Variability (as measured by Holter-Monitoring)
Change in Opioid Use (Quantitative)
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in opioid use assessed with quantitative urine opioid panel
Change in Opioid Use (Self-Report)
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in opioid use assessed with daily electronic diaries
Change in Perceived Stress Scale
时间窗: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Perception of stress; score range: 0-40 (low stress - high stress)
次要结局
- Change in non-opioid substance use(Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal)
- Change in State-Trait Anxiety Inventory (STAI)(Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal)
- Change in Depression (Beck Depression Inventory-II)(Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal)
- Change in 36-Item Short Form Survey (SF-36)(Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal)
- Change in Objective Wake After Sleep Onset (Actigraph)(Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal)
- Change in NIH Toolbox(Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal)
- Change in Objective Sleep Onset Latency (Actigraph)(Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal)
- Change in Objective Sleep Efficiently (Actigraph)(Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal)
研究者
Christina McCrae
Professor, Director MizZzou Sleep Research Lab
University of Missouri-Columbia