[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opioid-analgesia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opioid-analgesia":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,61,85,119,145,182,209,235],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100640195","feasibility-of-protocolised-analgosedation-in-ecmo-100640195",false,"NCT07580781","Feasibility of Protocolised Analgosedation in ECMO","Feasibility of a Cluster Randomised Control Trial Evaluating a Co-designed Analgosedation Protocol in Extracorporeal Membrane Oxygenation (ECMO) Patients","ECMO-SED","Inclusion Criteria:\n\n* Aged 18 years and older\n* Receiving IV continuous infusions of analgosedation medication\n* Receiving ECMO treatment\n\nExclusion Criteria:\n\n* There will be no exclusion criteria as analgosedation management is routine for all adult ECMO patients.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.\n\nA sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.\n\nHowever, there are no protocols for giving sedation to ECMO patients in research papers. Investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.\n\nAims:\n\nTo see whether it is possible to run a trial that compares using a sedation protocol against usual care.\n\nDesign\u002Fmethods:\n\nThirty to 60 ECMO patients will be chosen and will be put into one of two groups. One group will receive usual care, and the other will receive care using the sedation protocol. The investigators will collect information from both groups to find out if the study design works and how many patients agree to take part.\n\nPatient and public involvement\u002Fengagement:\n\nThe investigators received feedback from patients and family member participants which helped to design this proposal, the lay summary and what to measure in a trial. They will advise how the investigators should review study findings, and support sharing of results to the public.\n\nImpact\u002Fdissemination:\n\nThe investigators will share findings through social media, patient charities, research papers and conferences.",[27,28,29,30,31,32,33,34],"Intensive Care (ICU)","Respiratory Distress Syndrome (RDS)","Sedation and Analgesia","Extracorporeal Membrane Oxygenation","Sedation for Mechanical Ventilation","Cardiogenic Shock","Opioid Analgesia","Analgesia",[36,37,38,39,40,41,42,43,44,45,46,47],"extracorporeal membrane oxygenation","sedation","opioid","sedative","analgosedation","mechanical ventilation","ECMO","ICU","Intensive Care Unit","Critical Care","sedation protocol","analgesia","NOT_YET_RECRUITING","2026-05-05",{"date":51,"type":52},"2026-05-12","ACTUAL",{"date":54,"type":21},"2026-09-01",{"date":56,"type":21},"2027-08-31",{"name":58,"class":59},"Guy's and St Thomas' NHS Foundation Trust","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":15,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":84,"locationsCount":60},"100595479","improving-sedation-practice-in-critically-ill-adult-patients-using-a-co-designed-sedation-protocol-100595479","NCT07032987","Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol","Optimising Analgosedation in Extracorporeal Membrane Oxygenation (ECMO) Using a Co-designed Analgosedation Protocol","Stage 1 (multi-centre observational study):\n\nInclusion Criteria:\n\n1. Aged 18 years and older.\n2. Receiving continuous IV infusions of analgosedation (opioids, benzodiazepines, and\u002For propofol).\n3. Receiving ECMO for moderate to severe respiratory failure (PaO2\u002FFiO2 (P\u002FF) ratio \\\u003C20 kilopascals (kPa)) for ≤ 7 days during the week of recruitment.\n4. Non-ECMO ICU patients (control group): must satisfy inclusion criteria 1 and 2, and have received mechanical ventilation for moderate to severe respiratory failure (P\u002FF ratio \\\u003C 20kPa) for at least 48 hours OR mechanical ventilation for cardiovascular disorder (out of hospital cardiac arrest, following cardiothoracic or transplant surgery or percutaneous coronary intervention or acute heart failure).\n\nExclusion Criteria:\n\n1. Anticipated length of ICU stay in recruiting centre for less than 24 hours.\n2. Withdrawal of life-sustaining treatment in the next 24 hours.\n\nStage 2 (mixed methods study):\n\nInclusion Criteria:\n\n1. Healthcare professionals working at one of two ECMO centres (St Thomas' Hospital and Royal Brompton Hospital (part of Guy's and St Thomas' NHS Foundation Trust).\n2. ECMO survivors (patients admitted to ICU and survived ECMO organ support) who have returned home, and recovered.\n3. Family members of ECMO survivors, whose relative is no longer hospitalised.\n\nExclusion Criteria:\n\n1. ECMO survivors currently receiving treatment in hospital.\n2. ECMO survivors with severe cognitive issues (issues with short-term memory and thinking).\n3. ECMO survivors who cannot communicate in English.\n4. Non-ECMO survivors and family members.","100 Years",{"count":70,"type":21},120,"OBSERVATIONAL","Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.\n\nA sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.\n\nHowever, there are no protocols for giving sedation to ECMO patients in research papers. The investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.\n\nAims:\n\n* To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients.\n* To develop a sedation protocol for ECMO patients with input from patients, their family, and staff.\n\nDesign\u002Fmethods:\n\nStudy 1:\n\nThe investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2.\n\nStudy 2:\n\nThe investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group.\n\nPatient and public involvement\u002Fengagement:\n\nThe investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. They will advise how the investigators should review study findings, and support sharing of results to the public.\n\nImpact\u002Fdissemination:\n\nThe investigators will share findings through social media, patient charities, research papers and conferences.",[74,28,29,75,31,32,33,34],"Intensive Care Medicine","ExtraCorporeal Membrane Oxygenation (ECMO)",[36,37,38,77,40,41,42,43,44,45,46,47],"sedatives","RECRUITING",{"date":80,"type":52},"2026-05-08",{"date":82,"type":52},"2025-11-24",{"date":56,"type":21},{"name":58,"class":59},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":60},"100618643","retrolaminar-analgesia-for-lumbar-surgery-100618643","NCT07334288","Retrolaminar Analgesia for LuMbar Surgery","Efficacy of Ultrasound-Guided Retrolaminar Block Combined With Standard Multimodal Analgesia for Postoperative Pain Management in Lumbar Spine Surgery: A Randomized Controlled Trial","REALM","Inclusion Criteria:\n\n* Adult patients aged 18-80 years\n* Scheduled for elective lumbar spine surgery (with instrumentation)\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Willing and able to provide written informed consent\n* Able to use patient-controlled analgesia (PCA) device\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Known allergy to local anesthetics (bupivacaine - levobupivacaine - lidocaine) or any study medication\n* Contraindication to regional anesthesia (infection at injection site, coagulopathy)\n* Chronic opioid use (daily use for \\>3 months prior to surgery)\n* Severe psychiatric disorder that precludes informed consent\n* Emergency surgery\n* Diabetes mellitus with preoperative glucose \\>180 mg\u002Fdl\n* Pregnancy or breastfeeding\n* Body mass index (BMI) \\>40 kg\u002Fm²\n* Reoperation or revision of the same level of previous spinal surgery","80 Years",{"count":95,"type":21},50,[24],"This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up.",[99,100,101,33,102],"Postoperative Pain","Lumbar Surgery","Back Pain Lower Back Chronic","Regional Anaesthesia",[104,105,106,107,108,109],"retrolaminar block","regional anesthesia","lumbar spine surgery","Multimodal analgesia","opioid consumption","Ultrasound-guided nerve block","2026-04-10",{"date":112,"type":52},"2026-04-13",{"date":114,"type":52},"2026-03-01",{"date":116,"type":21},"2027-06-01",{"name":118,"class":59},"Universidad de los Andes, Chile",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100613631","phase-4-efficacy-and-safety-of-anrikefon-for-postoperative-analgesia-in-ophthalmic-surgery-100613631","NCT07269106","Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery","Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery: A Multicenter, Randomized, Parallel-Control, Non-Inferiority Trial","Inclusion Criteria:\n\n* Scheduled for ophthalmic surgery under general anesthesia.\n* Aged 18 to 70 years.\n* With American Society of Anesthesiologists (ASA) physical status I to III.\n* Body mass index (BMI) between 18 and 30 kg\u002Fm²\n* Agree to participate in the trial and provide written informed consent.\n\nExclusion Criteria:\n\n* History of cardiovascular or cerebrovascular events within the past 6 months, including unstable angina, ischemic myocardial infarction, or heart failure; or current presence of uncontrolled hypertension (\\>180\u002F110 mmHg), aneurysm, or severe cardiac arrhythmia.\n* Severe respiratory diseases such as pulmonary fibrosis, severe pulmonary abscess, cor pulmonale, or advanced chronic obstructive pulmonary disease (COPD).\n* Significant neurological disorders such as brain injury or seizures, as well as severe psychiatric illnesses.\n* Known allergy to kappa opioid receptor agonists or to general anesthetic agents used in this study.\n* Current peptic ulcer disease, gastrointestinal bleeding, or known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), such as flurbiprofen axetil or paracetamol.\n* Prior use of opioid or non-opioid analgesics, with the last administration occurring within five half-life periods of the drug.\n* Continuous use of opioid analgesics for more than 10 days within the 3 months prior to screening.\n* Use of drugs with unknown half-life periods that may affect analgesic efficacy within 14 days before randomization.\n* History of major surgery within the past 3 months that may interfere with postoperative pain assessment.","70 Years",{"count":128,"type":21},204,[130],"PHASE4","The goal of this clinical trial is to learn if Anrikefon works as well as nalbuphine to control postoperative pain in adults undergoing ophthalmic surgery under general anesthesia. It will also learn about the safety and recovery outcomes of using Anrikefon.\n\nThe main questions it aims to answer are:\n\n* Does Anrikefon provide pain relief that is not inferior to nalbuphine after ophthalmic surgery?\n* Does Anrikefon cause fewer central side effects, such as sedation or dizziness, compared with nalbuphine?\n* Does Anrikefon help patients recover and get discharged faster after day-surgery procedures? Researchers will compare Anrikefon to nalbuphine to see if Anrikefon can offer effective and safer perioperative analgesia for ophthalmic day-surgery patients.\n\nParticipants will:\n\n* Receive either an intravenous dose of Anrikefon or nalbuphine during surgery.\n* Be monitored for pain scores, side effects, and recovery parameters after surgery.\n* Complete follow-up assessments.",[133,134,33],"Ophthalmic Surgery","Postoperative Pain Management","2026-03-31",{"date":137,"type":52},"2026-04-01",{"date":139,"type":52},"2026-01-22",{"date":141,"type":21},"2027-12-31",{"name":143,"class":59},"Zhongshan Ophthalmic Center, Sun Yat-sen University",3,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":162,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":60},"100589085","phase-4-buprenorphine-as-a-post-operative-analgesic-in-opioid-naive-patients-after-ankle-fracture-surgery-100589085","NCT06949826","Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery","A Single-institution, Parallel, Double-blinded, Randomized Study Assessing the Safety and Efficacy of Transdermal Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery","BAFA","INCLUSION CRITERIA:\n\n* Patient is 18 years of age or older\n* Patient is undergoing single stage ORIF of an ankle fracture\n* Patient is English-speaking\n\nEXCLUSION CRITERIA:\n\n* Patient is under 18 years of age\n* Patient's ankle fracture is treated with external fixation\n* Patient has a concomitant osseous or visceral injury\n* Patient has a history of opioid use disorder or a current diagnosis of opioid use disorder\n* Patient has a history of alcohol use disorder or a current diagnosis of alcohol use disorder\n* Patient was taking opioid medication or narcotic drugs prior to their injury\n* Patient has a current active malignancy\n* Patient is taking a medication that carries a prohibitively high risk of drug-drug interaction with buprenorphine, hydrocodone, or oxycodone in the view of their treating physician or nurse anesthetist\n* Patient has an anaphylactic allergy to buprenorphine, hydrocodone, or oxycodone\n* Patient is not English-speaking\n* Patient is pregnant\n* Patient is unable to complete pain diary or communicate pain scores\n* Patient is incarcerated\n* Patient has a Gustilo-Anderson Type III open fracture",{"count":154,"type":21},100,[130],"Addictive full-agonist opioids, like oxycodone and hydrocodone, are often used to treat pain after surgery. However, these full-agonist opioids can be very addictive. After ankle fracture surgery, about 1 in 5 patients that did not take opioids before surgery become addicted to opioids after surgery. Buprenorphine is an opioid with unique properties that may offer a way to reduce the number of patients that become addicted to opioids after surgery. Buprenorphine has good analgesic (painkilling) effects. It is also thought to be less addictive and cause less of a high than full-agonist opioids, like oxycodone and hydrocodone. This project's goal is to determine if transdermal buprenorphine can safely and effectively control pain after ankle fracture surgery. This study will be a pilot study, which sets the stage for future studies that investigate whether buprenorphine can reduce the rate that patients become addicted to opioids after surgery. This study's multidisciplinary team will divide patients into two groups. Participants in one group will be treated with a 7-day transdermal buprenorphine patch (where the buprenorphine is slowly absorbed through the skin over 7 days). Participants in the other group will be treated with a placebo patch. A placebo has no drug in it, it just looks like the buprenorphine patch. Aside from the buprenorphine patch or placebo patch, both groups' pain management plans will be the same as if they were not in the study. Over the first week after surgery, the investigators will measure the amount of full-agonist opioids (for example, oxycodone or hydrocodone) that participants consume, participants' pain scores, the frequency of side effects related to opioids, and the number of calls and patient portal messages to the clinic for uncontrolled pain. The investigators will also assess whether participants are continuing to use opioids 3 months after surgery for pain related to their ankle fracture.",[158,159,160,161,33],"Pain, Postoperative","Ankle Fracture Surgery","Opioid Use Disorder","Opioid Dependence",[163,164,165,166,167,168,169,170,171,172],"Buprenorphine","Postoperative pain","Transdermal buprenorphine","Ankle fracture surgery","Ankle fracture","Opioid-naive patient","ORIF Ankle Fracture","Opioid use disorder","Opioid Addiction","Buprenorphine for postoperative pain","2026-03-30",{"date":175,"type":52},"2026-04-06",{"date":177,"type":52},"2025-04-21",{"date":179,"type":21},"2027-06",{"name":181,"class":59},"Jenna-Leigh Wilson",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":197,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":60},"100625516","phase-4-continous-infusion-of-nefopam-for-patients-undergoing-pancreatoduodenectomy-100625516","NCT07423650","Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy","Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial","Inclusion Criteria:\n\n1. Patients scheduled for elective pancreatoduodenectomy surgery\n2. Agreed to participate in the study\n\nExclusion Criteria:\n\n1. Refusal to participate\n2. Emergency surgery\n3. Patients with neurological disorders or other muscular or psychiatric disorders that impede communication\n4. Known allergic reactions to the used medication\n5. Known hyperalgesia\n6. Chronic opioid consumption\n7. Patients that require reintervention in the first 48h postoperatively\n8. Patients with pancreaticogastrostomy",{"count":190,"type":21},93,[130],"The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy.\n\nThe main questions are:\n\nDoes nefopam administration reduce opioid consumption after pancreatoduodenectomy?\n\nDoes nefopam administration reduce postoperative pain levels after pancreatoduodenectomy?\n\nResearchers will compare two other analgesic strategies, namely continuous lidocaine infusion and epidural analgesia, to assess whether they lead to better outcomes.\n\nParticipants will complete the QoR-15 questionnaire and report their pain levels at predefined time points before and after surgery.",[194,195,33,196],"Pancreatoduodenectomy","Pain Management","Multimodal Analgesia",[198,194,199,107],"Nefopam","Opioids","2026-03-19",{"date":202,"type":52},"2026-03-24",{"date":204,"type":21},"2026-03",{"date":206,"type":21},"2026-10",{"name":208,"class":59},"Iuliu Hatieganu University of Medicine and Pharmacy",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":215,"sex":17,"minAge":18,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":225,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":60},"100609743","phase-1-evaluation-of-the-safety-and-effects-of-psychoactive-substances-in-people-with-past-opioid-use-100609743","NCT07218549","Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use","Inclusion Criteria:\n\n1. English-speaking, 18- to 55-year-old males or females.\n2. Female subjects must have a negative serum pregnancy test at time of screening and negative urine pregnancy test upon admission. In addition, female subjects must meet one of the following conditions:\n\n   * Is a woman of non-childbearing potential defined as no menses for at least 12 months with status confirmed by FSH and estradiol levels at screening or surgically sterile at screening visit OR\n   * Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1%, from Screening until 9 months after receiving the study medication. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the dose of study intervention.\n3. Male subjects must agree to the following from Day 1 until 9 months after receiving the study medication:\n\n   • Not donate fresh unwashed semen\n\n   Plus, either:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n   * Use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.\n   * Use a male condom when engaging in any activity that allows for passage of ejaculate to another person\n4. Physically healthy, as determined by a clinical interview with a physician, laboratory tests (urinalysis, blood chemistry, 12-lead ECG), physical examination, and self-reported medical history.\n5. No current or past diagnosis of severe mental illness, as determined by a clinical interview.\n6. Clinical laboratory test results (CMP, CBC, etc.) must be within the normal reference range or with acceptable deviations that are judged to be not clinically significant by a study physician.\n7. Have a history of self-reported recreational opioid use as defined by at least 10 times in the past year and at least once in the 12 weeks before screening.\n8. Able and willing to give signed informed consent, reliable, and willing to make themselves available for the study's duration and follow study procedures.\n9. Agree not to consume any recreational drugs during the study (THC is excluded).\n10. Able to perform study procedures as determined by clinical judgment.\n11. Able to meet eligibility requirements of the Qualification Phase (i.e., drug discrimination) and Naloxone Challenges.\n\nExclusion Criteria:\n\n1. Seeking treatment for a substance or alcohol use disorder as determined by self-report during the intake interview.\n2. Current or past diagnosis of opioid use disorder or other substance use disorder (SUD) within the past year, excluding THC and nicotine-containing products. With regard to marijuana\u002FTHC, an individual must be able to tolerate 48 hours of abstinence from marijuana\u002FTHC products.\n3. History of opioid overdose.\n4. Using medication or supplements that might interact with kratom or oxycodone as determined by self-report during intake interview.\n5. Treatment with any investigational drug during the last 30 days.\n6. Participants on parole or probation.\n7. Currently pregnant or trying to conceive or currently lactating as determined by blood pregnancy testing at screening, urine pregnancy testing at admission, and self-reporting during interview and study visits.\n8. Current or recent history of significant violent or suicidal behavior or suicidal\u002Fhomicidal risk as determined by the C-SSRS.\n9. Sensitivity, allergy, or contraindications\u002Fallergies to kratom, opioids, or similar compounds.\n10. Use prescription or nonprescription drugs and dietary supplements within seven days or five half-lives (whichever is longer) that, in the opinion of the study clinician may interfere with the investigational product.\n11. Positive urine drug screen (UDS) for substances of abuse at each admission in the Qualification and Treatment phases, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at their discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participant is permitted to participate in any phase of the study.\n12. Positive alcohol breathalyzer test at each admission in the Qualification and Treatment Phase.\n13. History of sensitivity to heparin or heparin-induced thrombocytopenia.\n14. Has not donated blood or plasma within the last six weeks.\n15. Has a history of increased intracranial pressure or brain tumors.\n16. Has gastrointestinal obstruction, including paralytic ileus.\n17. Has a history of seizure disorders.\n18. Has a chronic obstructive pulmonary disease or cor pulmonale.\n19. Has a history of anemia or any other significant hematologic disorder.\n20. Has a condition or abnormality that, in the opinion of the PI or Study Physician, would compromise the safety of the patient or the quality of the data.\n21. Has a major surgery planned within the next 6 months.",true,"55 Years",{"count":218,"type":21},72,[220],"PHASE1","The purpose of this study is to understand how kratom affects people. In this study, kratom will be compared with another substance and a placebo (an inactive substance). Researchers will also study how the substances move through and affect the body. This includes examining how the body absorbs, processes, and eliminates the drug (pharmacokinetics), as well as how the drug affects the body and how it may make you feel (pharmacodynamics). The information collected will help researchers better understand the effects and potential risks of kratom.",[223,224,33],"Opioid Use","Substance Use Disorders",[223,224],"2026-03-11",{"date":228,"type":52},"2026-03-13",{"date":230,"type":21},"2026-05-01",{"date":232,"type":21},"2029-05-31",{"name":234,"class":59},"Christopher D. Verrico",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":60},"100600819","evaluation-of-an-opioid-stewardship-program-in-non-cancer-patients-100600819","NCT07102446","Evaluation of an Opioid Stewardship Program in Non-Cancer Patients","Inclusion Criteria:\n\n* Outpatients at the Department of Anesthesiology and Pain Medicine or the Department of Physical Medicine \\& Rehabilitation of the study site who received a prescription for opioid analgesics (oral, transdermal, sublingual, or buccal formulations containing oxycodone, fentanyl, tapentadol, hydrocodone, or morphine) due to chronic non-cancer pain during the study evaluation period (from IRB approval date to September 30, 2025)\n* Adults aged ≥19 years and \\\u003C80 years\n* Patients who voluntarily signed a written informed consent form after receiving a full explanation of the study and understanding its purpose\n\nExclusion Criteria:\n\n* Patients with active cancer\n* Patients diagnosed with sickle cell disease\n* Patients diagnosed with a life-limiting illness eligible for hospice or palliative care as defined in Article 2 of the 'ACT ON HOSPICE AND PALLIATIVE CARE AND DECISIONS ON LIFE-SUSTAINING TREATMENT FOR PATIENTS AT THE END OF LIFE'\n* Pregnant patients\n* Patients who were prescribed opioid analgesics within the past month for postoperative pain management\n* Patients who were prescribed opioid analgesics within the past month for newly developed pain\n* Patients with communication difficulties\n* Patients who were prescribed buprenorphine for the treatment of opioid use disorder\n* Patients who are deemed inappropriate for study participation at the discretion of the investigator","19 Years","79 Years",{"count":244,"type":21},70,[24],"The objective of this prospective, non-randomized clinical trial is to evaluate the effectiveness of a pharmacist-led Opioid Stewardship Program (OSP) in outpatient adults with chronic non-cancer pain. This study compared OSP implementation with a historical control to determine whether it reduces the incidence of high-risk opioid prescribing and improves patients' awareness, knowledge, and attitudes about opioid use.",[248,249,33,223],"Pain","Chronic Pain",[251,195,252,253],"Pharmacist","Opioid Stewardship","Non-Cancer Pain","2025-07-28",{"date":256,"type":52},"2025-08-03",{"date":258,"type":52},"2025-06-27",{"date":260,"type":21},"2026-06",{"name":262,"class":59},"Korea University Guro Hospital"]