protocolSection identificationModule nctId: NCT06345872, orgStudyIdInfo id: STUDY005883, secondaryIdInfos id: 1R01DA054311, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DA054311, briefTitle: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Pain, conditions: Chronic Insomnia, conditions: Opioid Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 165, type: ESTIMATED, armsInterventionsModule interventions name: CBT-I, interventions name: Treatment as usual, interventions name: Tapered Withdrawal, outcomesModule primaryOutcomes measure: Change in Insomnia Severity Index, primaryOutcomes measure: Change in Pain Intensity - Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Sleep Onset Latency- Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Sleep Efficiency- Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Fatigue - Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Perceived Stress Scale, primaryOutcomes measure: Change in Peripheral Arousal, primaryOutcomes measure: Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging, primaryOutcomes measure: Change in Thermal Pain Response, primaryOutcomes measure: Change in Opioid Use (Quantitative), primaryOutcomes measure: Change in Opioid Use (Self-Report), secondaryOutcomes measure: Change in Objective Wake After Sleep Onset (Actigraph), secondaryOutcomes measure: Change in Objective Sleep Onset Latency (Actigraph), secondaryOutcomes measure: Change in Objective Sleep Efficiency (Actigraph), secondaryOutcomes measure: Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging, secondaryOutcomes measure: Short Inventory of Problems, secondaryOutcomes measure: Change in Pain Catastrophizing Scale, otherOutcomes measure: Change in 36-Item Short Form Survey (SF-36), otherOutcomes measure: Change in Depression (Beck Depression Inventory-II), otherOutcomes measure: Change in State-Trait Anxiety Inventory (STAI), otherOutcomes measure: Medications/Substances Uses and Dosages, otherOutcomes measure: Change in Subjective Opioid Withdrawal Scale (SOWS), otherOutcomes measure: Change in Opioid Cravings Scale, otherOutcomes measure: Change in NIH Toolbox, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Florida, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Christina S McCrae, PhD, role: CONTACT, phone: 813-974-1804, email: christinamccrae@usf.edu, contacts name: Jasmine L Niazi, MS, role: CONTACT, phone: (813) 906-0483, email: jlniazi@usf.edu, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False