[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580481":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":35,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":38,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid Group","EXPERIMENTAL","The participant will be plugged into an individualized comprehensive tiered pain plan that can include: Tier one (Acetaminophen, NSAIDS, Topicals, TENS unit, Massage, Acupuncture, Physical therapy. Tier two (Cognitive behavioral therapy, joint injections, nerve ablations, peripheral nerve stimulators) and less commonly Tier three (duloxetine, gabapentin). This is modeled after clinical practice. The participants will additionally receive prescription opioids for 6 weeks.",[13],"Drug: Opioid",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","The participant will be plugged into an individualized comprehensive tiered pain plan that can include: Tier one (Acetaminophen, NSAIDS, Topicals, TENS unit, Massage, Acupuncture, Physical therapy. Tier two (Cognitive behavioral therapy, joint injections, nerve ablations, peripheral nerve stimulators) and less commonly Tier three (duloxetine, gabapentin). This is modeled after clinical practice. The participants will additionally receive a prescription opioid placebo for 6 weeks.",[19],"Drug: Opioid Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Opioid","Subjects will receive oral oxycodone as needed for pain which will be titrated weekly based on pain response, adverse effects, and patient preference. Subjects with intolerance to oxycodone will receive the equivalent dosing of morphine as an alternative.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Opioid Placebo","Subjects will receive a placebo capsule identical to oxycodone, which will similarly be titrated weekly. Subjects with intolerance to the first placebo will receive another placebo capsule identical to morphine.",[15],[32],{"name":33,"affiliation":5,"role":34},"Nafisseh Warner","PRINCIPAL_INVESTIGATOR",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-92.4699,44.02163,{"lat":48,"lon":47},[51,56],{"name":52,"role":53,"phone":54,"phoneExt":26,"email":55},"Tami Werts","CONTACT","507-255-2950","Werts.Tamra@mayo.edu",{"name":57,"role":34,"phone":26,"phoneExt":26,"email":26},"Nafisseh S Warner, MD",{"type":34,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Nafisseh S. Warner","Principal Investigator","100580481","phase-2-prescription-opioids-brain-structure-and-cognition-in-older-adults-with-chronic-pain-100580481",false,"NCT06837857","Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain","Imaging, Cognition, and Opioids in Older Adults With Chronic Pain (I-COAP) Trial","I-COAP","Inclusion Criteria:\n\n* 65 years of age or older\n* Pain for longer than 3 months (chronic)\n* Moderate to severe pain nearly every day (averaged PEG score \\>5)\n* Persistent pain despite use of \\>1 analgesic (Tylenol, Ibuprofen, lidocaine patch, etc)\n\nExclusion Criteria:\n\n* Untreated severe\u002Funcontrolled Mental health (schizophrenia, bipolar disorder, psychosis, history of suicidality, depression or anxiety, PTSD)\n* Severe liver (cirrhosis) or kidney disease (ESRD on dialysis or GFR\\\u003C 30)\n* Cognitive impairment (Kokmen Short Test of Mental Status score \\\u003C 29)\n* Life expectancy \\\u003C 12 months\n* Contraindications to MRI\n* Non-English speaking\n* Opioid use within the past 6 months\n* Contraindications or previous intolerance to prescription opioids\n* Substance use disorder or high-risk for opioid-related adverse effects (Opioid Risk Tool ≥ 8)\n* Residence outside of Minnesota or Wisconsin during opioid intervention period\n* Another pain generator that is greater than their knee or shoulder or low back pain\n* Anticipated surgery for joint replacement (Knee or shoulder) sooner than 3 months.","ALL","65 Years",{"count":72,"type":73},200,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The purpose of this study is to determine whether exposure to prescription opioids is associated with brain structural changes on magnetic resonance imaging (MRI), with the primary outcome of white matter integrity as measured by fractional anisotropy of the corpus callosum.",[79],"Pain, Chronic","2026-01-07",{"date":82,"type":83},"2026-01-08","ACTUAL",{"date":85,"type":83},"2025-04-16",{"date":87,"type":73},"2029-12-31",{"name":5,"class":6},1]