Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Официальное название

SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое CBT-I
  Includes 8 weekly sessions of CBT-I and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
• Поведенческое Treatment as usual
  Includes 8 weekly sessions of standard treatment and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
• Другое Tapered Withdrawal
  Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.

Первичные конечные точки

• Change in Insomnia Severity Index [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Pain Intensity - Daily Electronic Sleep Diaries [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Sleep Onset Latency- Daily Electronic Sleep Diaries [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Sleep Efficiency- Daily Electronic Sleep Diaries [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Fatigue - Daily Electronic Sleep Diaries [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Perceived Stress Scale [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Peripheral Arousal [Срок оценки: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]

Вторичные конечные точки (6)

• Change in Objective Wake After Sleep Onset (Actigraph) [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Objective Sleep Onset Latency (Actigraph) [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Objective Sleep Efficiency (Actigraph) [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Short Inventory of Problems [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]
• Change in Pain Catastrophizing Scale [Срок оценки: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of South Florida — Tampa

Публикации

• 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. PMID 30496533
• 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. PMID 32126156
• 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. PMID 16459140
• 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. PMID 30176973
• 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. PMID 22396516
• 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. PMID 23744045

Идентификаторы

NCT: NCT06345872 · STUDY005883 · 1R01DA054311

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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