[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06345872":3,"trial-entities:NCT06345872":189,"trial-summary:NCT06345872":192},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":48,"secondary_outcomes":90,"sex":109,"minimum_age":110,"maximum_age":111,"healthy_volunteers":15,"eligibility_criteria":112,"std_ages":138,"locations":141,"central_contacts":160,"overall_officials":163,"references":168,"see_also_links":188},"NCT06345872","STUDY005883","Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain","SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain","RECRUITING","2028-07-01","2026-04","2026-04-21","2024-12-11","University of South Florida","OTHER",true,"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.","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.",[19,20,21],"Chronic Pain","Chronic Insomnia","Opioid Use",[23,24,25,26],"Chronic pain","Chronic insomnia","Opioid use","CBT-I","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},165,"ESTIMATED",[35,40,44],{"type":36,"name":26,"description":37,"armGroupLabels":38},"BEHAVIORAL","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.",[39],"Experimental",{"type":36,"name":41,"description":42,"armGroupLabels":43},"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.",[41],{"type":14,"name":45,"description":46,"armGroupLabels":47},"Tapered Withdrawal","Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.",[39,41],[49,53,56,59,62,65,68,71,74,78,81,84,87],{"measure":50,"description":51,"timeFrame":52},"Change in Insomnia Severity Index","Insomnia severity; score range 0-28 (low severity - high severity)","Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up",{"measure":54,"description":55,"timeFrame":52},"Change in Pain Intensity - Daily Electronic Sleep Diaries","Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)",{"measure":57,"description":58,"timeFrame":52},"Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries","Daily electronic dairies will record wake after sleep onset (number of minutes)",{"measure":60,"description":61,"timeFrame":52},"Change in Sleep Onset Latency- Daily Electronic Sleep Diaries","Daily electronic dairies will record sleep onset latency (number of minutes)",{"measure":63,"description":64,"timeFrame":52},"Change in Sleep Efficiency- Daily Electronic Sleep Diaries","Daily electronic dairies will record sleep efficiency",{"measure":66,"description":67,"timeFrame":52},"Change in Fatigue - Daily Electronic Sleep Diaries","Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)",{"measure":69,"description":70,"timeFrame":52},"Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries","Daily electronic dairies will record daily medication consumption)",{"measure":72,"description":73,"timeFrame":52},"Change in Perceived Stress Scale","Perception of stress; score range: 0-40 (low stress - high stress)",{"measure":75,"description":76,"timeFrame":77},"Change in Peripheral Arousal","Heart Rate Variability (as measured by Holter-Monitoring)","5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up",{"measure":79,"description":80,"timeFrame":52},"Change in Neural Imaging: Structural\u002FFunctional MRI\u002FDiffusion Weighted Imaging","Assessment of neural plasticity",{"measure":82,"description":83,"timeFrame":52},"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)",{"measure":85,"description":86,"timeFrame":52},"Change in Opioid Use (Quantitative)","Change in opioid use assessed with quantitative urine opioid panel",{"measure":88,"description":89,"timeFrame":52},"Change in Opioid Use (Self-Report)","Change in opioid use assessed with daily electronic diaries",[91,94,97,100,103,106],{"measure":92,"description":93,"timeFrame":52},"Change in Objective Wake After Sleep Onset (Actigraph)","Wake after sleep onset via GENEActiv",{"measure":95,"description":96,"timeFrame":52},"Change in Objective Sleep Onset Latency (Actigraph)","Sleep Onset Latency via GENEActiv",{"measure":98,"description":99,"timeFrame":52},"Change in Objective Sleep Efficiency (Actigraph)","Sleep Efficiency via GENEActiv",{"measure":101,"description":102,"timeFrame":52},"Change in Neural Connectivity: Structural\u002FFunctional MRI\u002FDiffusion Weighted Imaging","Assessment of brain connectivity",{"measure":104,"description":105,"timeFrame":52},"Short Inventory of Problems","Modified from validated alcohol survey for opioid related problems",{"measure":107,"description":108,"timeFrame":52},"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.","ALL","18 Years",null,{"inclusion":113,"exclusion":122,"raw_text":137},[114,115,116,117,118,119,120,121],"18+ yrs","willing to be randomized,","can read\u002Funderstand 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",[123,124,125,126,127,128,129,130,131,132,133,134,135,136],"unable to provide informed consent","cognitive impairment (MMSE \\\u003C26)","sleep disorder other than insomnia \\[i.e., sleep apnea (apnea\u002Fhypopnea 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\u002Fintent, 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\u002Fconfirmed lumbar nerve root compression","confirmed lumbar spinal stenosis","\\\u003C6 mos post-back surgery","other spinal disorders","Inclusion Criteria:\n\n* 18+ yrs\n* willing to be randomized,\n* can read\u002Funderstand English\n* diagnosed with chronic widespread pain and insomnia (as described below)\n* prescribed opioid medication for 1+ mo, 3+ times per week\n* desire to reduce or eliminate opioid use\n* written agreement from physician prescribing opioid medication\n* no prescribed or OTC sleep meds for 1+ mo, or stabilized on meds for 6+ wks\n\nExclusion Criteria:\n\n* unable to provide informed consent\n* cognitive impairment (MMSE \\\u003C26)\n* sleep disorder other than insomnia \\[i.e., sleep apnea (apnea\u002Fhypopnea index, AHI \\>15)\n* Periodic Limb Movement Disorder (myoclonus arousals per hour \\>15)\\]\n* bipolar or seizure disorder (due to risk of sleep restriction treatment)\n* other severe, untreated major psychopathology except for depression or anxiety (e.g.,suicidal ideation\u002Fintent, psychotic disorders)\n* psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep (medications prescribed for pain or sleep are allowed)\n* participation in other non-pharmacological treatment for pain, sleep, or mood outside the current trial\n* internal metal objects or electrical devices\n* pregnancy\n* presumptive\u002Fconfirmed lumbar nerve root compression\n* confirmed lumbar spinal stenosis\n* \\\u003C6 mos post-back surgery\n* other spinal disorders",[139,140],"ADULT","OLDER_ADULT",[142],{"facility":13,"status":8,"city":143,"state":144,"zip":145,"country":146,"contacts":147,"geoPoint":157},"Tampa","Florida","33612","United States",[148,153],{"name":149,"role":150,"phone":151,"email":152},"Christina S McCrae, PhD","CONTACT","813-974-1804","christinamccrae@usf.edu",{"name":154,"role":150,"phone":155,"email":156},"Britani Holland, PhD","8139741804","blalone@usf.edu",{"lat":158,"lon":159},27.94752,-82.45843,[161,162],{"name":149,"role":150,"phone":155,"email":152},{"name":154,"role":150,"phone":155,"email":156},[164,166],{"name":149,"affiliation":13,"role":165},"PRINCIPAL_INVESTIGATOR",{"name":154,"affiliation":13,"role":167},"STUDY_DIRECTOR",[169,173,176,179,182,185],{"pmid":170,"type":171,"citation":172},"30496533","BACKGROUND","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\u002Fsleep\u002Fzsy234.",{"pmid":174,"type":171,"citation":175},"32126156","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\u002Fjsr.13020. Epub 2020 Mar 3.",{"pmid":177,"type":171,"citation":178},"16459140","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\u002Fj.sleep.2005.08.008. Epub 2006 Feb 3.",{"pmid":180,"type":171,"citation":181},"30176973","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\u002Fjcsm.7344.",{"pmid":183,"type":171,"citation":184},"22396516","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\u002Fjama.2012.234.",{"pmid":186,"type":171,"citation":187},"23744045","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\u002Fs10865-013-9520-y. Epub 2013 Jun 7.",[],{"nct_id":4,"conditions":190,"biomarkers":191},[20,19],[],{"nct_id":4,"found":15,"summary":193,"prompt_version":203},{"design":194,"status":195,"heading":196,"summary":197,"follow_up":198,"word_count":199,"commitments":200,"compensation":201,"drugs_mentioned":202},"This interventional study plans to enroll 165 participants who will be randomly assigned to receive either CBT-I or a standard behavioral treatment.","completed","Improving Sleep and Reducing Opioid Use for Chronic Pain","This study is looking for people with chronic widespread pain and chronic insomnia (trouble sleeping) who are also taking opioid medication. It aims to see if two different behavioral treatments can help improve sleep and reduce opioid use. One treatment is called CBT-I (Cognitive Behavioral Therapy for Insomnia), and the other is a standard treatment, both given in weekly online sessions. All participants will also receive support for gradually reducing their opioid medication. The study will measure changes in your insomnia, pain intensity, and how much you wake up after falling asleep, over several months. We are looking to enroll 165 participants, but the current status of the study is unclear.","Your progress will be monitored at baseline, 8 weeks, after completing opioid withdrawal, and at a 6-month follow-up.",111,"You would complete 8 weekly online sessions, each lasting less than 45 minutes, followed by 2 bi-monthly booster sessions. You would also receive support for gradually reducing your opioid medication.","Not stated in the trial record.",[26],"v2"]