[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-opioid-use\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-opioid-use":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100531582","phase-4-low-dose-short-term-ketorolac-to-reduce-chronic-opioid-use-in-orthopaedic-polytrauma-patients-100531582",false,"NCT06201676","Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients","Inclusion Criteria:\n\n* Patient age: 18-70\n* Patient or legally authorized representative (LAR) able to provide consent\n* Patients with acute musculoskeletal trauma requiring surgical fixation (i.e. ORIF with plates and screws and\u002For intramedullary nailing)\n* Anticipated hospital admission\n* Patients who speak English or Spanish\n* Patients who can be followed at the enrolling facility for at least 6 months\n\nExclusion Criteria:\n\n* Patient age \\\u003C 18 or \\> 70 years\n* Patients with injury more than 24 hours prior to evaluation\n* Patients with active hemorrhagic shock or risk of significant hemorrhage\n* Patients who are pregnant or breastfeeding\n* Patients with a history of active gastrointestinal bleeds or ulceration\n* Patients with chronic use of steroids or immune-modulating drugs or history of organ transplantation\n* Patients with preexisting chronic renal, liver, heart, or lung disease\n* Patients with a creatinine ≥ 1.30 mg\u002FdL during enrollment\n* Patients with history of myocardial infarction, stroke, or bleeding disorder\n* Patients with head or chest injury requiring surgical intervention\n* Patients with allergy to ketorolac or hypersensitivity to aspirin\n* Patients receiving chronic opioid therapy or treatment for opioid use disorder\n* Patients who are current IV drug users\n* Patients who require a daily NSAID or aspirin regimen, except for daily low-dose aspirin (81 mg)\n* Patients with insufficient follow-up or anticipated difficulty in completing follow-up at a study site for a minimum of 6 months due to any of the follow reasons: death, no follow-up after initial discharge, severe psychiatric conditions, unstable living conditions, planned follow-up at another medical center not participating in this study, live far away from the clinic, and\u002For incarcerated","ALL","18 Years","70 Years",{"count":19,"type":20},458,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic trauma patients. The main questions this study aims to answer are:\n\n1. Are patients who are given scheduled ketorolac during the first five days of the perioperative period in combination with standard of care (SOC) multimodal analgesia (MMA) less likely to develop chronic opioid use at 6 months after injury compared to patients who SOC MMA alone?\n2. Does scheduled ketorolac during the first five days of the perioperative period improve functional responses to pain at discharge, 3 months, and 6 months after injury?\n3. Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both?\n\nParticipants will be enrolled and randomized to either the ketorolac (treatment) group or the SOC group. Patients randomized to the ketorolac group will receive ketorolac every 6 hours for up to five days during the perioperative period; patients discharged prior to completing the five-day regimen will complete the remainder of treatment with oral ketorolac. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury.\n\nResearchers will compare patients receiving ketorolac (treatment) plus SOC versus those receiving SOC alone to determine if ketorolac reduces chronic opioid use and improves the functional response to pain.",[26,27],"Orthopaedic Trauma","Chronic Opioid Use",[29,30,31,32,33],"orthopaedic trauma","chronic opioid use","NSAID","IV ketorolac","acute pain management","RECRUITING","2026-05-13",{"date":37,"type":38},"2026-05-14","ACTUAL",{"date":40,"type":38},"2025-02-28",{"date":42,"type":20},"2027-08-31",{"name":44,"class":45},"Massachusetts General Hospital","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100533260","va-transitional-pain-service-study-100533260","NCT06223503","VA Transitional Pain Service Study","Reducing Chronic Opioid Use Among Veterans Undergoing Community Care Surgery Using a Transitional Pain Service","VATPS","Inclusion Criteria:\n\nAims 1 \\& 3:\n\n* The investigators will include Veterans who are referred to the Veteran Community Care Program (VCCP) for an orthopedic surgery procedure from any VA medical center throughout VISN-19.\n* Additionally, these Veterans must be 18+ years of age who are not on chronic opioids at the time of surgery, and who have a VA primary care provider (PCP).\n\nAim 2:\n\n* Veterans who received TPS (Aim 1) and referring VA Primary Care Providers.\n\nExclusion Criteria:\n\nAim 1:\n\n* The investigators will exclude Veterans who are scheduled for other types of surgical procedures, are on chronic opioid therapy before surgery, are on hospice or end-of-life care, are cognitively impaired, or unable to complete the follow-up visits for any other reason.\n\nAim 2:\n\n* The investigators will exclude Veterans not randomized to the TPS Telehealth intervention of Aim 1.\n\n  * Primary Care Providers will be excluded if they do not primarily work at the VA.\n\nAim 3:\n\n* The investigators will exclude Veterans who were not randomized to the TPS Telehealth intervention.\n* Veterans who experienced a major complication during the perioperative period or experienced an extended length of stay (LOS) based on exceeding the upper interquartile range of median LOS.\n* Exclusion criteria for this aim also include patients on hospice care, individuals discharged to a care facility, and those with scheduled readmissions for follow up procedure(s) within 90-days.",{"count":56,"type":20},400,[58],"NA","The VA Community Care Program has provided an important resource to improve access to surgical care for Veterans unable to have treatment at VA Medical Centers (VAMC). However, there is an increased risk of developing chronic opioid use when at-risk surgical patients receive opioids from non-VA providers. A multidisciplinary approach to perioperative pain management known as the Transitional Pain Service (TPS) has been shown to effectively reduce chronic opioid use among Veterans after surgery, but it is unknown whether it can be used to achieve the same outcomes for Veterans using Community Care for high-risk surgery. Through this project, the investigators will generate important data to establish whether a telehealth TPS approach can serve as a scalable and effective strategy to ensure safe opioid use among Veterans undergoing orthopedic surgery. The investigators will randomize Veterans using Community Care for orthopedic surgery to telehealth TPS versus standard of care. Finally, the investigators will interview patients using Community Care to better understand barriers and facilitators to telehealth TPS and Veteran satisfaction with the approach to pain management.",[27],[62,63,64,65,66,67],"Post-operative pain","Opioid use disorder","Opioid misuse","MISSION Act","Community Care","Transitional Care Coordination","2026-04-29",{"date":70,"type":38},"2026-05-06",{"date":72,"type":38},"2024-03-01",{"date":74,"type":20},"2027-07-01",{"name":76,"class":77},"VA Office of Research and Development","FED",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":78},"100465278","phase-1-reversal-of-opioid-induced-respiratory-depression-with-opioid-antagonists-100465278","NCT05338632","Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists","Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists - a Study in Opioid naïve Individuals and Chronic Opioid Users Under Real-life Conditions","ROAR","Inclusion Criteria:\n\nHealthy volunteers\n\n1. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;\n2. Male and female subjects, age 18 to 70 years, inclusive;\n3. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug;\n4. Body Mass Index (BMI) 18 to 30 kg\u002Fm2, inclusive;\n5. Healthy as defined by the Investigator, based on a medical evaluation that includes the subject's medical and surgical history, physical examination, vital signs, lab chemistry: estimated glomerular filtration rate \\>60 mL\u002Fmin as estimated by the CKD-EPI equation, and AST or ALT levels \\\u003C 3.0 times the upper limit of normal at screening, and negative serology tests for HIV, acute hepatitis B, or acute hepatitis C;\n6. No history of substance use disorder;\n\nChronic opioid users\n\n1. Signed the consent form and able to comply with the requirements and restrictions listed therein;\n2. Males or females age 18 to 70 years, inclusive;\n3. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 3 month after the last dose of study drug.\n4. BMI 18 to 32 kg\u002Fm2, inclusive;\n5. Opioid tolerant patients administered prescription opioids at daily doses ≥ 60 mg oral morphine equivalents (See Table 3);\n6. Stable as defined by the Investigator, based on a medical evaluation that includes the subject's medical and surgical history, physical examination, vital signs, 12-lead ECG, hematology, and blood chemistry;\n\nExclusion Criteria:\n\nHealthy volunteers\n\n1. Currently meet the criteria for diagnosis of substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria on any substance;\n2. Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;\n3. Consume, on average, \\>27 20 units\u002Fweek of alcohol in men and \\> 20 13 units\u002Fweek of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);\n4. Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration;\n5. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;\n6. History of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent;\n7. Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;\n8. History or presence of allergic response to fentanyl, sufentanil or naloxone;\n9. Subjects who have demonstrated allergic reactions (e.g., food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the Investigator and sponsor, interfere with their ability to participate in the trial;\n10. Treatment with another investigational drug within 3 months prior to dosing or having participated in more than 4 investigational drug studies within 1 year prior to screening;\n11. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study;\n\nChronic opioid users\n\n1. Currently meet the criteria for diagnosis of moderate or severe substance use disorder according to the DSM-5 criteria on any substances other than opioids, caffeine, or nicotine;\n2. Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;\n3. Consume, on average, \\>27 units\u002Fweek of alcohol in men and \\>20 units\u002Fweek of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);\n4. Currently receiving medication-assisted treatment for the treatment of opioid-use disorder;\n5. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;\n6. History of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent;\n7. Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;\n8. History or presence of allergic response to study medication;\n9. Opioid tolerant patients who have demonstrated allergic reactions (e.g., food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the Investigator and sponsor, interfere with their ability to participate in the trial.\n10. Estimated glomerular filtration rate \\\u003C60 mL\u002Fmin as estimated by the CKD-EPI equation;\n11. Anemia at screening or donation of \\> 250 mL of blood or plasma within the last 3 months;\n12. Positive serology tests for HIV, acute hepatitis B, or acute hepatitis C (OT patients with asymptomatic hepatitis B or C infection may be enrolled);\n13. AST or ALT levels \\>3.0 times the upper limit of normal at screening;\n14. Treatment with another investigational drug within 3 months prior to dosing or having participated in more than 4 investigational drug studies within 1 year prior to screening;\n15. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study.",true,{"count":89,"type":20},24,[91],"PHASE1","n this pharmacokinetic\u002Fpharmacodynamic modelling study we will determine the ability of intranasal and intravenous naloxone and intravenous nalmefene to reverse opioid (fentanyl and sufentanil)- induced respiratory depression in healthy volunteers and chronic opioid users to develop dosing recommendations in case of opioid-induced respiratory depression from an opioid overdose in clinical practice and in the out-of-hospital overdose.",[94,27],"Opioid Induced Respiratory Depression",[96,97],"Reversal of opioid induced respiratory depression","Intranasal naloxone","2025-01-29",{"date":100,"type":38},"2025-01-31",{"date":102,"type":38},"2022-06-24",{"date":104,"type":20},"2026-10-01",{"name":106,"class":45},"Leiden University Medical Center"]