[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opioid-misuse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opioid-misuse":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,68,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100518173","phase-3-cares-comprehensive-analgesic-recovery-and-education-support-for-surgery-trial-100518173",false,"NCT06027099","CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial","Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Surgery","CARES","INCLUSION CRITERIA:\n\n* 18 to 75 years of age\n* Able to speak, write, and read fluently in English\n* Scheduled for elective surgery at\n\n  * Stanford University Medical Center,\n  * Brigham and Women's Hospital (Harvard University),\n  * Atrium Health Wake Forest Baptist Medical Center (Wake Forest University), or\n  * University of Kansas Medical Center\n* Preoperative long-term opioid use (Defined as ≥ 60-day supply of opioids in the 180-day period prior to surgery), identified via self-report, state Prescription Drug Monitoring Program (PDMP), or Electronic Medical Records (EHR). Days may be nonconsecutive, and actual use of opioid supply is not required.\n* Willing and able to complete online assessments and study calls independently\n* On the preoperative Baseline assessments, least one of the following:\n\n  * Current Opioid Misuse Measure (COMM-17): score ≥ 9\n  * Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1): Reported use more frequent than \"Never\" on any item except Tobacco; for Tobacco, \"Yes\" to at least one item on the TAPS-2 for Tobacco\n  * Alcohol Use Disorders Identification Test (AUDIT-C): score ≥4 (men), ≥3 (women)\n  * Modified Brief Pain Inventory (mBPI): \"Yes\" to at least one of the following:\n\n    * Over the past 24 hours have you needed to take your pain medication to help you sleep?\n    * Have you taken any pain medications for any reason other than your pain, such as to reduce anxiety or improve mood?\n    * Have you taken more pain medication than was prescribed to you in the past 24 hours?\n* At the Post-Operative Call (7-13 days post-op): Postoperative daily opioid dose ≥ preoperative daily opioid dose (identified during the Pre-Surgery Call 5-1 day before surgery), measured in Morphine Milligram Equivalents (MME).\n\nEXCLUSION CRITERIA\n\n* Infection, tumor, or fracture at the operative site\n* Allergy or intolerance to tizanidine\n* Current use of tizanidine\n* Renal impairment (Creatinine Clearance \\[CrCl\\] \\\u003C 25 ml\u002Fmin)\n* Hepatic impairment, including cirrhosis or elevated liver enzymes\n* Concurrent use of other α2-adrenergic agonists, skeletal muscle relaxants\n* Concurrent use of: fluvoxamine, ciprofloxacin,zileuton, fluoroquinolones, antiarrhythmics (amiodarone, mexiletine, propafenone, verapamil), cimetidine, famotidine, oral contraceptive pills, acyclovir, ticlopidine, and fexinidazole\n* Pre-existing hypotension, sedation, dizziness, severe respiratory insufficiency.\n* Opioid Use Disorder\n* Suicidality as assessed by the Patient Health Questionnaire-9 (PHQ-9) Question 9 score ≥ 1\n* Pregnancy, breastfeeding, or planning to conceive\n* Planned cancer treatment in the \\\u003C 3 months following surgery\n* Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)\n* Participating in another clinical trial with an active treatment arm","ALL","18 Years","75 Years",{"count":21,"type":22},375,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to learn whether a combined behavioral and pharmacologic intervention can help reduce opioid use, improve pain recovery, and prevent opioid misuse after surgery in adults undergoing elective surgery. The study includes adults aged 18 to 75 who have a history of long-term opioid use, defined as having access to opioids for 60 or more days within the 180 days before surgery.\n\nThe main questions it aims to answer are:\n\n* Does Motivational Interviewing with guided opioid tapering plus tizanidine (MI-Opioid Taper + Tizanidine) help participants return to their preoperative opioid use level or stop opioids faster than Enhanced Usual Care (EUC)?\n* Does the intervention reduce the time to pain resolution and decrease the likelihood of opioid misuse after surgery compared to EUC?\n\nResearchers will compare MI-Opioid Taper + Tizanidine to MI-Opioid Taper with placebo and to EUC to see whether the intervention improves postoperative opioid and pain outcomes.\n\nParticipants will:\n\n* Complete a phone assessment and baseline survey before surgery\n* Be randomly assigned 7-13 days after surgery to one of three groups:\n\n  * MI-Opioid Taper + tizanidine (MTT)\n  * MI-Opioid Taper + placebo (MTP)\n  * Enhanced Usual Care (EUC)\n* Complete brief weekly phone or video visits with a study clinician for 6 weeks starting 14 days after surgery\n* Take a study medication (tizanidine or placebo) three times daily for 5 weeks (MTT and MTP groups only)\n* Complete weekly online surveys for 6 months, followed by monthly surveys until 12 months after surgery to track pain, opioid use, and related outcomes",[28,29,30,31],"Chronic Pain","Back Pain","Neck Pain","Opioid Misuse","RECRUITING","2026-05-01",{"date":35,"type":36},"2026-05-06","ACTUAL",{"date":38,"type":36},"2024-12-05",{"date":40,"type":22},"2028-07",{"name":42,"class":43},"Stanford University","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":67},"100559537","opioid-and-pain-treatment-in-indigenous-communities-optic-trial-100559537","NCT06565416","Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial","Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial: Implementation of Screening and Brief Intervention","OPTIC","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* have English comprehension and proficiency\n* receiving services at one of our participating study sites\n* report current chronic pain and\u002For opioid misuse\u002Fopioid use disorder\n* self-identify as American Indian\u002FAlaska Native\n\nExclusion Criteria:\n\n* if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process",{"count":53,"type":22},225,[55],"NA","The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse\u002Fopioid use disorder in three American Indian and Alaska Native (AI\u002FAN) serving clinics. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse\u002Fopioid use disorder.",[58,31,28],"Opioid Use Disorder","2025-11-10",{"date":61,"type":36},"2025-11-12",{"date":63,"type":36},"2023-06-01",{"date":40,"type":22},{"name":66,"class":43},"University of New Mexico",3,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":93,"locationsCount":95},"100556518","m2va-pain-care-pathway-100556518","NCT06526143","M2VA Pain Care Pathway","Implementation Facilitation of Screening, Brief Intervention, and Referral to Treatment for Pain Management for Veterans Separating From Military Service","M2VAPCP","Inclusion Criteria:\n\n* Study enrollment is within one year of ending military service\n* Has filed a service-connection claim for an MSD (back, neck, knee, or shoulder condition)\n* Lives within the catchment area of a participating site\n\nExclusion Criteria:\n\n* Reports being unable to complete planned study assessments because of anticipated incapacity, incarceration, or other reason\n* Does not have a landline or cell phone to complete study assessments\n* Is unable to provide informed consent\n* Still on active duty",{"count":77,"type":22},1800,[55],"The goal of this 2-cohort, cluster randomized, type 2 hybrid trial is to test the effectiveness, cost-effectiveness and patient-level effects of an implementation facilitation strategy in helping M2VA case managers adopt a Military2VA Pain Care Pathway (M2VAPCP) intervention.\n\nThe main questions it aims to answer are:\n\nWill adding implementation facilitation to training-as-usual for M2VAPCP result in a higher proportion of Veterans who receive M2VAPCP compared to training-as-usual alone? Will adding implementation facilitation to training-as-usual for M2VAPCP result in better adherence to the M2VAPCP protocol compared to training-as-usual alone? Will implementation facilitation improve Veterans' clinical outcomes (pain, risky substance use) and increase the number of non-pharmacological pain treatments used compared to training-as-usual alone?",[81,82,31,83],"Pain","Substance Use","Quality of Life",[85,86],"case management","SBIRT","2025-11-04",{"date":89,"type":36},"2025-11-05",{"date":91,"type":36},"2024-09-18",{"date":40,"type":22},{"name":94,"class":43},"Yale University",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":95},"100553721","opioid-misuse-in-patients-with-cancer-100553721","NCT06489769","Opioid Misuse in Patients with Cancer","Prevalence of Opioid Misuse in Patients with Cancer","Inclusion Criteria:\n\n* Outpatients ≥ 18 years,\n* patients who are treated with opioids due to cancer-related pain.\n\nExclusion Criteria:\n\n* Patients who do not master the Danish language in speech and writing,\n* Patients who have severe cognitive dysfunction,\n* Patients who are not treated with opioids,\n* Patients who refused to participate in the study.",{"count":104,"type":22},200,"OBSERVATIONAL","The success of opioid treatment in terminally ill cancer patients set the stage for extending the same treatment principles to the treatment of all chronic pain conditions including chronic non-cancer pain and chronic pain in cancer, where survival and long-standing chronic disease trajectories are getting more prevalent due to increasing survival rates. In this context, opioid misuse as such has been highly neglected - especially in palliative care, but also in cancer pain management in general. Previous studies have explored the literature on opioid misuse among adult cancer patients, noting that the available evidence is still in its early stages. Limited prospective studies with a wide range of definitions and methodologies for assessing misuse exist. Therefore, it seems highly relevant and justified to study the prevalence of opioid misuse risk in patients with cancer. The hypothesis of this study is that opioid misuse is not uncommon in Danish patients in treatment with opioids for cancer-related pain. Thus, the prevalence of opioid misuse risk among patients with cancer in Danish palliative care units will be investigate.",[108,109,31,81,110],"Cancer","Opioid Use","Cancer Pain","2025-03-21",{"date":113,"type":36},"2025-03-25",{"date":115,"type":36},"2025-01-15",{"date":117,"type":22},"2025-12-31",{"name":119,"class":43},"Rigshospitalet, Denmark"]