Clinical trial NCT06345872: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
Official title: SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Chronic Insomnia
Opioid Use
Keywords: Chronic pain
Chronic insomnia
Opioid use
CBT-I
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-04-03
Enrollment: 165
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: 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.

Detailed description: Opioid therapy is commonly prescribed for patients with chronic widespread musculoskeletal pain, but offers questionable benefit for long-term pain management and is associated with arrhythmias, overdose, and death. Individuals with chronic pain experience high rates of comorbid chronic insomnia, arousal, and abnormal brain activation in response to painful stimuli. Research shows individuals with chronic pain exhibit increased brain activation in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids is difficult; and inadequately managed pain contributes to that difficulty. The Cognitive Activation Theory of Stress (CATS) tests the hypothesis that poor sleep and arousal lead to critical changes in brain activation that increase pain severity and lead to opioid use. Research shows cognitive behavioral treatment for insomnia (CBT-I, an evidence based intervention for chronic insomnia) improves sleep, arousal, abnormal brain activation, and pain in individuals with comorbid chronic pain and insomnia, but does not reduce opioid use. However, because CBT-I improves each of the mediators hypothesized to contribute to opioid use, it warrants examination as a neoadjuvant to gradual tapering of opioid medication. The proposed trial tests the novel hypothesis that improving sleep and decreasing arousal will lead to normalized brain activation and decreased pain prior to gradual tapering, which will facilitate reduced opioid use. This hypothesis is supported by theory (CATS) and empirical findings. It also reflects federal pain research priorities.

Eligibility criteria: Inclusion Criteria:

* 18+ 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 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 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

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Pain Intensity - Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Sleep Efficiency- Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Fatigue - Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Perceived Stress Scale
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Peripheral Arousal
timeFrame: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Thermal Pain Response
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Opioid Use (Quantitative)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Opioid Use (Self-Report)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Secondary outcomes:
measure: Change in Objective Wake After Sleep Onset (Actigraph)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Objective Sleep Onset Latency (Actigraph)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Objective Sleep Efficiency (Actigraph)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Short Inventory of Problems
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Pain Catastrophizing Scale
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Other outcomes:
measure: Change in 36-Item Short Form Survey (SF-36)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Depression (Beck Depression Inventory-II)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in State-Trait Anxiety Inventory (STAI)
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Medications/Substances Uses and Dosages
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Subjective Opioid Withdrawal Scale (SOWS)
timeFrame: Single administration at 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in Opioid Cravings Scale
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
measure: Change in NIH Toolbox
timeFrame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Christina S McCrae, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCrae CS, Williams J, Roditi D, Anderson R, Mundt JM, Miller MB, Curtis AF, Waxenberg LB, Staud R, Berry RB, Robinson ME. Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial. Sleep. 2019 Mar 1;42(3):zsy234. doi: 10.1093/sleep/zsy234.
citation: McCrae CS, Curtis AF, Miller MB, Nair N, Rathinakumar H, Davenport M, Berry JR, McGovney K, Staud R, Berry R, Robinson M. Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia. J Sleep Res. 2020 Dec;29(6):e13020. doi: 10.1111/jsr.13020. Epub 2020 Mar 3.
citation: Morin CM, LeBlanc M, Daley M, Gregoire JP, Merette C. Epidemiology of insomnia: prevalence, self-help treatments, consultations, and determinants of help-seeking behaviors. Sleep Med. 2006 Mar;7(2):123-30. doi: 10.1016/j.sleep.2005.08.008. Epub 2006 Feb 3.
citation: McCrae CS, Mundt JM, Curtis AF, Craggs JG, O'Shea AM, Staud R, Berry RB, Perlstein WM, Robinson ME. Gray Matter Changes Following Cognitive Behavioral Therapy for Patients With Comorbid Fibromyalgia and Insomnia: A Pilot Study. J Clin Sleep Med. 2018 Sep 15;14(9):1595-1603. doi: 10.5664/jcsm.7344.
citation: Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234.
citation: Martinez MP, Miro E, Sanchez AI, Diaz-Piedra C, Caliz R, Vlaeyen JW, Buela-Casal G. Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. J Behav Med. 2014 Aug;37(4):683-97. doi: 10.1007/s10865-013-9520-y. Epub 2013 Jun 7.