[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opioid-use-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opioid-use-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,195,0,25,[9,44,75,105,125,151,172,197,218,240,264,285,310,338,359,379,403,427,455,484,502,525,553,579,602],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100610827","impact-of-federal-and-state-medications-for-opioid-use-disorder-moud-policy-changes-during-the-pandemic-100610827",false,"NCT07232641","Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic","Comparing Treatment Use, Retention, and Patient Outcomes Pre- and Post-implementation of Federal Policy Changes Regulating Buprenorphine and Methadone Treatment for Opioid Use Disorder","IMPACT","Inclusion Criteria:\n\n* Substance use disorder (alcohol and\u002For opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)\n\nExclusion Criteria:\n\n* None","ALL","18 Years",{"count":21,"type":22},185810,"ESTIMATED","OBSERVATIONAL","\"Gold-standard\" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide \"whole-patient\" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent.\n\nThis study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.",[26,27,28],"Substance Use Disorders","Alcohol Use Disorder","Opioid Use Disorder",[30],"Medications for opioid use disorder (MOUD)","RECRUITING","2026-07-01",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2026-06-30",{"date":39,"type":22},"2029-09",{"name":41,"class":42},"Boston University","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100602823","phase-2-ketones-for-opioid-craving-100602823","NCT07128524","Ketones for Opioid Craving","Ketone Supplementation for Opioid Craving and Withdrawal","Inclusion Criteria:\n\n* Age 18-75 years\n* Meets currents DSM-5 criteria for OUD and admitted for opioid withdrawal management treatment at Caron Treatment Center\n* Willingness to provide signed, informed consent and commit to completing the procedures in the study\n\nExclusion Criteria:\n\n* Current severe gastrointestinal (GI), liver, or other clinically significant physical disease that may interfere with the intake of the ketone supplement (e.g., sever inflammatory bowel disease, cirrhosis).\n* Currently taking (within the past two weeks) GLP-1 receptor agonist medications, e.g. semaglutide, which can interfere with the absorption of the ketone supplement\n* Currently pregnant or lactating, for people of childbearing potential\n* Judged by the principal investigator. study physician, or their designee to be an unsuitable candidate for the study","75 Years",{"count":53,"type":22},50,"INTERVENTIONAL",[56],"PHASE2","The goal of this clinical trial is to learn if ketone supplementation (KS) works to reduce craving for opioids for adults with opioid use disorder (OUD) undergoing in-patient acute withdrawal management. The main questions it aims to answer are:\n\n* Does KS reduce craving for opioids in patients with opioid use disorder?\n* Does KS reduce symptoms of opioid withdrawal such as low mood and pain? Researchers will compare KS to a placebo to see if KS works to reduce craving for opioids and reduce withdrawal symptoms in adults entering in-patient acute withdrawal management for opioid use disorder.\n\nParticipants will:\n\n* Be given KS or a placebo three (3) times daily for seven (7) days\n* Complete mood, pain tolerance, and subjective opioid withdrawal assessments",[28],[60,61,62,63,64,65,66],"opioid use disorder","OUD","ketone","ketone supplement","ketone supplementation","craving","withdrawal","NOT_YET_RECRUITING",{"date":34,"type":35},{"date":70,"type":22},"2026-07",{"date":72,"type":22},"2027-09",{"name":74,"class":42},"University of Maryland, Baltimore",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":54,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":43},"100606750","kentucky-womens-justice-community-overdose-innovation-network---phase-ii-100606750","NCT07179614","Kentucky Women's Justice Community Overdose Innovation Network - Phase II","WJCOIN-II","Inclusion Criteria:\n\n* DSM-5 scores of 2+ for opioids (OUD) and\u002For stimulants (StUD),\n* no evidence of cognitive impairment in providing consent,\n* a release date within 7-60 days to allow for time for intervention sessions,\n* willingness to consider SUD treatment post-release, and\n* willingness to provide the name and contact information of at least one person in the community who will support the woman's recovery pre\u002Fpost-release (SP).\n\nExclusion Criteria:\n\n* Not living in a rural area\n* Any condition that would not allow capable informed consent",true,"FEMALE",{"count":85,"type":22},300,[87],"NA","This project continues our work with women in the Kentucky Women's Justice Community Overdose Innovation Network Phase II (WJCOIN-II) with the overall aim of reducing overdose risk during the transition from jail to rural communities. WJCOIN-II has potential for significant impact regarding the effectiveness, implementation, and sustainability of innovative overdose prevention strategies during the high-risk time of community re-entry among vulnerable, CLS-involved women in rural communities. This research will impact the field by increasing the capacity of the criminal legal system to respond to the overdose crisis through increased access to prevention strategies to reduce overdose risk.",[90,28,91],"Overdose Risk","Stimulant Use Disorders",[93,94,95,60,96],"Overdose","women","criminal justice","stimulant use disorder","2026-06-29",{"date":32,"type":35},{"date":100,"type":35},"2026-06-23",{"date":102,"type":22},"2030-10-30",{"name":104,"class":42},"Michele Staton",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":54,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":43},"100605156","phase-1-combined-tdcs-and-cognitive-training-as-an-adjunctive-treatment-in-opioid-use-disorder-100605156","NCT07158853","Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder","Inclusion Criteria:\n\n* Ability to provide consent and comply with study procedures\n* Diagnostic and Statistical Manual of Mental Disorders criteria for OUD\n* Undergoing medication treatment for OUD. Participants may have current comorbid drug use, but primary diagnosis must be OUD\n* Intention to remain in the study until intervention completion.\n\nExclusion Criteria:\n\n* Any medical condition with neurological sequelae\n* Head injury resulting in skull fracture or loss of consciousness of \\>30 minutes\n* Any tDCS or MRI contraindication (tDCS: history of seizures, metallic cranial plates\u002Fscrews or implanted device, history of eczema on scalp. MRI: unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, or claustrophobia)\n* Any psychotic disorder (participants with other treated and stable psychiatric disorders will be included)\n* Presence of a condition that would render study measures impossible to administer or interpret\n* Age younger than 18\n* Primary current substance use disorder on a substance other than opioids except for caffeine or nicotine\n* In treatment instead of jail\n* Pregnancy\n* Disrespectful behavior towards the investigators and staff.",{"count":112,"type":22},40,[114],"PHASE1","The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals taking medication for treatment for Opioid Use Disorder(OUD).",[28],"2026-06-26",{"date":37,"type":35},{"date":120,"type":35},"2026-02-04",{"date":122,"type":22},"2027-08-31",{"name":124,"class":42},"University of Minnesota",{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":54,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100589949","telehealth-vs-in-person-evaluation-of-addiction-treatment-after-visiting-the-emergency-department-100589949","NCT06961058","Telehealth vs In-Person Evaluation of Addiction Treatment After Visiting the Emergency Department","In Person vs Telehealth Opioid Use Disorder Treatment After Patients Leave the Emergency Department","TREATED","Inclusion Criteria:\n\n* Adult patients who present to the emergency department and receive buprenorphine (either administered or prescribed) to treat OUD\n* do not have an established outpatient clinic where they will get buprenorphine when they leave the emergency department\n\nExclusion Criteria:\n\n* inability to give consent\n* patients living in institutions (e.g., nursing homes, prisons)\n* unable to complete questionnaires in either English or Spanish",{"count":134,"type":22},528,[87],"Main study objective: compare long-term buprenorphine treatment outcomes for patients who start buprenorphine for opioid use disorder (OUD) in the emergency department and are then referred to get outpatient buprenorphine treatment either via telehealth or at an in-person clinic.\n\nResearchers will:\n\nCompare rates of establishing outpatient OUD treatment, how long patients stay on buprenorphine, and patients' experience with care to determine whether patient experiences and outcomes are better for patients referred to telehealth treatment versus patients patients referred to in-person treatment after they leave the emergency department.\n\nParticipants will:\n\nBe recruited from 3 different hospital emergency departments.\n\nAnswer questionnaires at baseline and then 1, 3, 6, and 9 months after their initial emergency department visit.",[28],[139,140,141,142],"emergency department","buprenorphine","telehealth","comparative effectiveness",{"date":97,"type":35},{"date":145,"type":35},"2025-06-03",{"date":147,"type":22},"2029-09-01",{"name":149,"class":42},"University of California, Davis",3,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":54,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":43},"100583120","using-clinical-decision-support-to-provide-social-risk-informed-care-for-opioid-use-disorder-in-the-emergency-department-100583120","NCT06872190","Using Clinical Decision Support to Provide Social Risk-Informed Care for Opioid Use Disorder in the Emergency Department","Inclusion criteria:\n\n* All University of California, San Francisco ED providers (residents, attendings, advanced practice providers) who have used either CDSv1 or CDSv2 will be eligible to participate in surveys and interviews regarding feasibility and acceptability.\n* English-speaking patients ≥18 years of age presenting to the UCSF ED with opioid use disorder who receive medication treatment (as a result of CDSv1 or CDSv2) will be eligible to participate.\n\nExclusion criteria:\n\n\\- Participants will be excluded if:\n\n* they have a medical or psychiatric condition requiring hospitalization at the index ED visit,\n* are actively suicidal, are cognitively impaired,\n* present from an extended care facility, or\n* require opioids for a pain condition.",{"count":85,"type":22},[87],"The overarching goal of this proposal is to integrate patient social risk information into an existing electronic health record (EHR)-based clinical decision support (CDS) tool (CDSv1) to facilitate emergency department (ED)-initiated, social risk-informed opioid use disorder (OUD) medication treatment and ultimately improve treatment adherence and follow up. The investigators will evaluate the feasibility and acceptability of the social care-enhanced CDS tool, CDSv2, (compared to CDSv1) at a single study site (UCSF) as an intervention to increase medication treatment adherence and follow up for adult ED patients experiencing opioid use disorder using a mixed-methods, before-after approach.",[28,161],"Social Determinants of Health (SDOH)",[163,164,60],"social risk-informed care","clinical decision support",{"date":97,"type":35},{"date":167,"type":35},"2025-04-20",{"date":169,"type":22},"2027-07",{"name":171,"class":42},"University of California, San Francisco",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":18,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":54,"phases":182,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":43},"100549319","tdcs-to-decrease-opioid-relapse-uh3-100549319","NCT06432465","tDCS to Decrease Opioid Relapse (UH3)","Inclusion Criteria:\n\n1. current opioid dependence\n2. between 21-60 years of age\n3. recent initiation of buprenorphine or methadone (≤90 days)\n4. enrolled in Butler Hospital's Alcohol and Drug Inpatient Unit, Alcohol and Drug Partial Hospital Treatment Program, Intensive Outpatient Services, or Outpatient Services at Butler Hospital OR receive opioid-treatment services in the community.\n\nExclusion Criteria:\n\n1. current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass\u002Finfection, hydrocephalus)\n2. bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder\n3. current suicidality\n4. evidence of significant neurocognitive dysfunction\n5. conditions associated with heightened tDCS risks, e.g., seizure disorder, nonremovable intracranial metal objects (other than dental fillings and dental implants), skin disease or active lesions on the scalp, migraine\u002Fother headache disorder with significant active symptoms, traumatic brain injury or skull fracture within the past year, any implanted medical devices or device components that can interact with electromagnetic fields or are controlled by physiological signals\n6. probation\u002Fparole requirements or an upcoming move that might interfere with protocol participation\n7. planning to terminate buprenorphine or methadone in less than 3 months\n8. current pregnancy or plan to become pregnant in the next month.","21 Years","60 Years",{"count":181,"type":22},100,[87],"Investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. In Phase I, the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC. In this current phase (II), the investigators will perform a larger randomized clinical trial (RCT) (active vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes.",[28],[186,140,187,188,189],"opioid craving","methadone","EEG","transcranial direct current stimulation",{"date":97,"type":35},{"date":192,"type":35},"2024-04-17",{"date":194,"type":22},"2026-12-31",{"name":196,"class":42},"Butler Hospital",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":54,"phases":205,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":43},"100550018","phase-2-extended-release-buprenorphine-as-a-novel-low-dose-induction-strategy-100550018","NCT06441604","Extended-release Buprenorphine as a Novel Low-dose Induction Strategy","Inclusion Criteria:\n\n* English speaking adults aged 18 and above.\n* diagnosis of opioid use disorder.\n* Self-reporting use of illicit opioids in \\>21 days in the prior 30 days.\n* Provide urine toxicology testing positive for fentanyl at baseline.\n\nExclusion Criteria:\n\n* Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.\n* Received buprenorphine or methadone treatment in prior 30 days.\n* Current diagnosis of alcohol or sedative\u002Fhypnotic use disorder.\n* Positive urine drug screen for benzodiazepines, alcohol and or methadone.\n* Physical dependence on alcohol or sedative\u002Fhypnotics.\n* Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed consent.\n* Have a history or diagnosis of Intracranial mass\u002Fbleed, seizure disorder, liver cirrhosis, renal failure, obstructive lung disease, hyperthyroidism, narrow-angle glaucoma, valvular heart disease, cardiac arrhythmias, heart failure.\n* Recent (within 6 months) head trauma, stroke, or myocardial infarction\n* Requiring treatment with opioids for acute or chronic pain.\n* History of hypersensitivity or allergy to buprenorphine or fentanyl.\n* Pregnant or breastfeeding.\n* Liver function test greater than 3 times upper normal limit.\n* Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.",{"count":204,"type":22},30,[56],"This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.",[28],[28,209],"Buprenorphine","2026-06-24",{"date":117,"type":35},{"date":213,"type":35},"2025-10-27",{"date":215,"type":22},"2027-01-31",{"name":217,"class":42},"Brigham and Women's Hospital",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":179,"enrollmentInfo":225,"targetDuration":4,"studyType":54,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":239},"100377698","exablate-for-lifu-neuromodulation-in-patients-with-opioid-use-disorder-oud-andor-other-substance-use-disorders-suds-100377698","NCT04197921","Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and\u002For Other Substance Use Disorders (SUDs)","A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD) and\u002For Other Substance Abuse Disorders (SUDs)","Inclusion Criteria:\n\n1. Males and non-pregnant females, age 18 - 60 years old\n2. Subject meets DSM-5 criteria for OUD and\u002For other SUDs including alcohol (assessed via the SCID-5) of at least two years duration\n3. Subject is currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; residential or inpatient treatment from the WVU Center for Hope and Healing or an affiliated WVU hospital; or receiving outpatient\u002Finpatient\u002Fresidential treatment from similar programs that are well known to the research team. If the subject is prescribed medication for AUD or OUD (e.g. buprenorphine-naloxone, naltrexone), they will be on a stable dose of the medication for the 7 days prior to the procedure. Stable is defined as within the therapeutic range but does not require same exact dose for 7 days.\n4. Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen\n5. The NAc is apparent on MRI such that treatment targeting can be performed directly (visible on MRI) and indirectly (using other anatomical structures for measurements)\n6. Subject is able to communicate sensations during the Exablate Transcranial procedure\n7. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits\n8. Subject is able to make own medical decisions as determined by the clinical team\n9. Subject has signed and received a copy of the approved informed consent form\n\nExclusion Criteria:\n\n1. Subjects who are taking medications which may adversely interact with MOUD (See Appendix B for full list). Being on one of these medications would not automatically exclude a participant from study participation, does not automatically exclude a prospective subject from study participation. If a prospective or current subject is taking any medication listed in Appendix B, the study investigator is responsible for determining whether the subject is eligible for inclusion or continued study participation.\"\n2. Subject with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices\n3. Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)\n4. Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)\n5. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp\n6. Subject with implanted objects in the skull or the brain\n7. Subject diagnosed with advanced kidney disease or on dialysis\n8. Subject with impaired renal function with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2\n9. Subject with known unstable cardiac status or severe hypertension including:\n\n   1. Documented myocardial infarction within six months of enrollment\n   2. Unstable angina on medication\n   3. Unstable or worsening congestive heart failure\n   4. Left ventricular ejection fraction below the lower limit of normal\n   5. History of a hemodynamically unstable cardiac arrhythmia\n   6. Cardiac pacemaker\n   7. Severe hypertension (diastolic BP \\> 100 on medication)\n10. Subject with history of abnormal bleeding, hemorrhage, or coagulopathy\n11. Subject receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure\n12. Abnormal coagulation profile (PLT \\\u003C 100,000\u002Fμl), PT (\\>13.9 sec) or PTT (\\>37.5 sec), and INR \\> 1.2. If values are outside the range of normal limits, any clinically significant value may be excluded as determined by a study investigator.\n13. Subject with cerebrovascular disease as determined by MRI according to the Fazekas criteria. Grades II and III on the Fazekas scale should be excluded\n14. Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced (assessed via SCID-5)\n15. Score of greater than 17 on the Hamilton Depression Rating Scale (HAM-D) or increased risk of suicide based on any positive response regarding passive or active suicidal ideation with or without intent over the past 3 months or lifetime history of active suicidal ideation with intent on the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline\n16. History of suicide attempt\n17. Parental history of completed suicide\n18. Subject meet the criteria for Cluster A or B Personality Disorders (assessed via SCID-5-PD)\n19. Diagnosis of dementia or any other disorder which has led to a clinically significant cognitive impairment (assessed via NIHTB-CB)\n20. Subject with brain tumors\n21. Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area\n22. Any known CNS infection or infection with the Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV). A diagnosis of Hepatitis C (HCV) alone is not exclusionary as long as hepatic function laboratory values are deemed not clinically significant by a study investigator and are ≤ 1.5 times the upper limit of normal.\n23. Subject who has had deep brain stimulation or a prior stereotactic ablation of the NAc, basal ganglia or thalamus\n24. Subject who has been administered botulinum toxins into the arm, neck, or face for 5 months prior to baseline\n25. Subject who is currently participating in another clinical investigation with an active treatment arm\n26. Subject unwilling to abstain from illicit substance use during the course of the study\n27. Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator\n28. Subject is non-English speaking\n29. Subject is pregnant or planning to be pregnant",{"count":226,"type":22},29,[87],"The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0\u002F2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and\u002For other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.",[230,26],"Opioid-use Disorder",{"date":117,"type":35},{"date":233,"type":35},"2019-11-27",{"date":235,"type":22},"2027-12-31",{"name":237,"class":238},"InSightec","INDUSTRY",4,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":54,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100589437","resilience-among-individuals-with-opioid-use-disorder-100589437","NCT06954402","Resilience Among Individuals With Opioid Use Disorder","A Novel Human Laboratory Model of Resilience Among Individuals With Opioid Use Disorder","Inclusion Criteria:\n\n1. Can provide informed consent and can comply with study procedures\n2. Adults aged ≥18 years\n3. Meet Diagnostic and Statistical Manual (DSM-5) criteria for current opioid use disorder or are currently receiving pharmacotherapy for the treatment of OUD (e.g. methadone or buprenorphine maintenance treatment \\[remission\\])\n4. Urine sample that tests positive for opioids\n5. Test negative for pregnancy at screening (females only)\n\nExclusion Criteria:\n\n1. Being pregnant or breastfeeding\n2. Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation",{"count":248,"type":22},125,[87],"The goal of this clinical trial is to develop a human laboratory model of resilience in people with opioid use disorder (OUD). The investigators aim to learn if objective tasks that measure cognitive, emotional, and control aspects of resilience match up with self-reported resilience during stress and non-stress situations.",[28],[253,60,254],"opioids","stress","2026-06-22",{"date":100,"type":35},{"date":258,"type":35},"2026-05-29",{"date":260,"type":22},"2029-04-30",{"name":262,"class":42},"Johns Hopkins University",2,{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":54,"phases":274,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":263},"100441796","phase-3-smartphones-for-opiate-addiction-recovery-100441796","NCT05033028","Smartphones for Opiate Addiction Recovery","SOAR","Inclusion Criteria:\n\nPatients:\n\n* Meet DSM-5 criteria for opioid-use disorder (heroin and\u002For prescription opioids);\n* Have entered, or expressed a clear intention to enter, an OUD treatment program that prescribes either methadone or buprenorphine\n* Any gender;\n* 18 years of age and older;\n* Have used opioids other than as specifically prescribed within thirty days prior to consent;\n* In good-enough general health;\n* Capacity to provide written informed consent as assessed by our Subject Comprehension Assessment Tool(subjects lacking the ability to consent will not be enrolled) ;\n* Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.\n\nStudy-Physician Participants.\n\n* Licensed MD employed by the respective site, or at a clinical partner of the respective site, where they will act as participants and be part of the treatment team\n* Currently practicing in the treatment of OUD with either Buprenorphine or Methadone;\n* Able to speak, read, and write English fluently and to provide informed consent in English\n\nClinician Participants.\n\n* Licensed MSW, NP, or MD; who are not part of any treatment team within the study and may be employees of their respective sites or other treatment facilities.\n* Currently practicing in the treatment of OUD with either Buprenorphine or Methadone;\n* Able to speak, read, and write English fluently and to provide informed consent in English\n\nExclusion Criteria:\n\nPatients:\n\n* Serious medical, psychiatric or non-opioid substance use disorder that, in the opinion of a study physician, would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study. Examples include: (a) Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and\u002For laboratory assessments;\n* Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and\u002For clinical interview;\n* Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included);\n* Suicidal or homicidal ideation that requires immediate attention;\n* Presence of pain of sufficient severity as to require ongoing pain management with opioids;\n* Pending legal action or other reasons that might prevent an individual from completing the study.\n* Pregnancy as assessed by urine pregnancy testing\n* Breastfeeding of infants, as assessed by self-report.\n* Prisoners, as defined by OHRP, are excluded from participation in the study.\n* Individuals receiving residential court-ordered substance abuse treatment.\n\nStudy-Physician Participants.\n\n* none\n\nClinician Participants.\n\n* none","85 Years",{"count":273,"type":22},225,[275],"PHASE3","Treatments for opioid addiction exist, but effectiveness is compromised when subjects use illicit opiates during treatment. Reuse rates during treatment can be high, and reducing illicit opiate use during treatment has thus recently become a major NIDA policy goal. The 5-minute battery indicates the numerical probability that a patient will reuse illicit opiates within the next 7-10 days.",[230],{"date":100,"type":35},{"date":280,"type":35},"2021-11-01",{"date":282,"type":22},"2027-12-01",{"name":284,"class":42},"NYU Langone Health",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":54,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":43},"100643978","phase-1-cannabis-effects-on-opioid-self-administration-100643978","NCT07668635","Cannabis Effects on Opioid Self-Administration","Impact of Cannabis on Opioid Self-Administration","Inclusion Criteria:\n\n* Participants with moderate to severe opioid use disorder who experience opioid withdrawal\n* No allergies or adverse reactions to cannabis or opioids\n* Willing to stay inpatient at the UK Hospital research center for approx. 6 weeks\n\nExclusion Criteria:\n\n* Individuals seeking treatment for opioid use disorder","55 Years",{"count":204,"type":22},[114],"The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive\u002Fdesire to take opioids.",[28,297],"Cannabis Use",[299,300],"opioid use","cannabis","2026-06-19",{"date":303,"type":35},"2026-06-25",{"date":305,"type":22},"2026-07-30",{"date":307,"type":22},"2031-07-30",{"name":309,"class":42},"Shanna Babalonis, PhD",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":54,"phases":320,"briefSummary":321,"conditions":322,"keywords":325,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":337},"100643571","buprenorphine-implementation-at-syringe-service-programs-to-reduce-overdoses-100643571","NCT07631598","Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses","Buprenorphine Implementation at Syringe Services Programs To Reduce Overdoses: A Type 1 Hybrid Effectiveness-Implementation Trial","BISTRO","Inclusion Criteria:\n\n1. ≥ 18 years old;\n2. Meet DSM-5 criteria for moderate or severe OUD;\n3. Interest in receiving buprenorphine treatment;\n4. Speaks English or Spanish;\n5. Currently an SSP client at the time of enrollment;\n6. Ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Current use of prescribed opioid agonist treatment, as assessed by self-report, at the time of enrollment;\n2. Unstable mental health or medical condition that requires an immediate clinical evaluation or higher level of care;\n3. Allergy to buprenorphine;\n4. Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law. or have pending legal action that could prevent participation on study activities.",{"count":319,"type":22},512,[87],"This study is testing whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people start and stay in treatment for opioid use disorder (OUD) than referring them to community buprenorphine treatment providers. Buprenorphine is a medication that helps reduce opioid cravings and withdrawal symptoms.\n\nThe study compares two ways of connecting people to treatment:\n\nReferral to a community treatment provider (usual care before the new program begins).\n\nOnsite, low-threshold buprenorphine treatment at the SSP, which allows participants to start medication quickly and without having to establish care at another provider.\n\nParticipants will be adults who have opioid use disorder and are SSP clients. Each SSP will begin offering the new onsite buprenorphine program at different times during the study. Researchers will collect information before and after the new program begins to see how it affects treatment engagement and health outcomes.\n\nThe study will also examine how easy or difficult it is for SSPs to start and run the new program, how acceptable it is to staff and participants, and whether it is cost-effective.\n\nThe overall goal is to find better ways to expand access to life-saving opioid treatment in community-based settings.",[28,323,324],"Opioid Use Disorder, Severe","Opioid Use Disorder, Moderate",[209,326,327,328,329],"Overdose Prevention","Low-Threshold Treatment","Community-Based Treatment","Medication for Opioid Use Disorder",{"date":100,"type":35},{"date":332,"type":22},"2026-08-10",{"date":334,"type":22},"2028-06",{"name":336,"class":42},"Montefiore Medical Center",8,{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":346,"targetDuration":4,"studyType":54,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100625257","phase-2-a-study-of-brenipatide-in-participants-with-opioid-use-disorder-100625257","NCT07420283","A Study of Brenipatide in Participants With Opioid Use Disorder","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)","RENEW-Op-1","Inclusion Criteria:\n\n* Have a current mild, moderate or severe opioid use disorder (OUD)\n* Are reliable and willing to make themselves available for the duration of the study (for example, are not incarcerated, not homeless) and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention Note: Participants who are not able to perform the injections must have the assistance of a support person trained to administer the study intervention\n  * store and use the provided study intervention as directed\n  * maintain electronic or paper study diaries, as applicable, and\n  * complete the required questionnaires\n* Are intermittently using non-legal, non-prescribed opioids\n* Are taking buprenorphine for treatment on OUD\n\nExclusion Criteria:\n\n* Evidence of other substance use disorder(s) within 180 days of screening, except the following are permitted: any level tobacco use disorder, mild-to-moderate alcohol or mild-to-moderate cannabis use disorder\n\nNote: any level of caffeine use is allowed\n\n* Are actively suicidal or deemed a significant risk for suicide\n* Have a history of advanced liver disease (including advanced liver fibrosis or cirrhosis or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score\n* Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening\n* Had opioid overdose in past 6 months prior to screening\n* Have a lifetime history or current diagnosis of the following:\n\n  * schizophrenia or other psychotic disorder\n  * bipolar disorder\n  * borderline personality disorder\n  * any eating disorder\n* Have type 1 diabetes mellitus, or a history of ketoacidosis, or hyperosmolar state, or coma",{"count":347,"type":22},465,[56],"The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone.\n\nThe maximum potential duration of study participation for a participant in Part A is approximately 144 weeks, maximum potential duration of study participation for a participant in Part B is approximately 116 weeks. The actual duration will vary for each participant depending on the time of enrollment and the overall rate of study enrollment.",[28],{"date":100,"type":35},{"date":353,"type":35},"2026-02-13",{"date":355,"type":22},"2028-03",{"name":357,"class":238},"Eli Lilly and Company",57,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":365,"enrollmentInfo":366,"targetDuration":4,"studyType":54,"phases":368,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":43},"100503007","early-phase-1-measuring-acute-drug-demand-in-humans-100503007","NCT05829655","Measuring Acute Drug Demand in Humans","Inclusion Criteria:\n\n* Age between 18 and 65 years old\n* Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)\n* Lifetime substance use history criterion \\[blinded\\]\n* Medically cleared to take suvorexant and blinded study medications\n* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Seeking opioid use treatment\n* Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff\n* Known contraindications or allergies to suvorexant and\u002For the blinded study medications","65 Years",{"count":367,"type":22},75,[369],"EARLY_PHASE1","This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.",[28,372],"Opioid Dependence",{"date":100,"type":35},{"date":375,"type":35},"2023-08-08",{"date":377,"type":22},"2028-01-01",{"name":74,"class":42},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":54,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":401,"locationsCount":43},"100571302","brief-digitally-enhanced-intervention-for-reducing-alcohol-use-during-moud-100571302","NCT06718491","Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD","Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD","Inclusion Criteria:\n\n* Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)\n* Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+\u002F15+ drinks per week \\[women\u002Fmen\\] with at least two binge episodes \\[4\u002F5+ drinks for women\u002Fmen in a 2 hour period\\] in the past month)\n* Elevated psychological distress defined as a total score of \\> 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)\n* 18 years of age or older\n* Can read and comprehend English\n\nExclusion Criteria:\n\n* Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent\n* Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)\n* Current comorbid moderate to severe substance use disorder other than alcohol and opioids\n* Limited or no access to a smart phone that is compatible with the mobile application\n* Participation in Phase One\n* Possibility of being pregnant (by self-report)\n* Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer",{"count":387,"type":22},80,[87],"The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are:\n\n* Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence?\n* Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity?\n\nResearchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence.\n\nParticipants will:\n\n* Complete a baseline electroencephalography (EEG) and self-report questionnaires.\n* Complete three one-hour intervention sessions (IMPROVE or control) each one week a part.\n* Complete a post-intervention EEG and self-report questionnaires.\n* Complete five ecological momentary assessment (EMA) surveys a day for 21 days.\n* Complete self-report questionnaires one-month after their last intervention session.",[28],[392,393,394,395],"Medications for Opioid Use Disorder","Heavy Alcohol Use","Ecological Momentary Assessments","Electroencephalography","2026-06-17",{"date":255,"type":35},{"date":399,"type":35},"2025-08-01",{"date":169,"type":22},{"name":402,"class":42},"Ohio State University",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":18,"minAge":410,"maxAge":365,"enrollmentInfo":411,"targetDuration":4,"studyType":54,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":43},"100389684","deep-brain-stimulation-effects-in-patients-with-opioid-use-disorder-100389684","NCT04354077","Deep Brain Stimulation Effects In Patients With Opioid Use Disorder","Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) for Patients With Treatment-refractory Opioid Use Disorder","Inclusion criteria\n\n1. Male and females age ≥ 22 years with diagnosis of opioid use disorder (OUD) based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) with at least a 5-year history\n2. OUD must be the primary disorder\n3. History of ongoing or previous opioid use, relapse, and\u002For cravings, despite attempts at, or attendance in, at least two different treatment modalities. These modalities may include: Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential treatment, inpatient treatment, alternative to intensive outpatient programs, Drug Dependence Unit programs, medication-assisted treatment (MAT), medication assisted recovery (MAR), inpatient or outpatient rehabilitation, detox programs, Narcotics Anonymous, individual or group therapy, Partial Hospitalization Programs (PHP), Sober living homes, or similar interventions.\n4. Self-reports ongoing opioid cravings.\n5. Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist\n6. Has completed a psychiatric evaluation to the satisfaction of a psychiatrist\n7. Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified\n8. Platelet count \\> 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits\n9. Negative blood cultures to rule out bacteremia\n\nExclusion criteria\n\n1. Prior brain surgery\n2. Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or moderate risk of suicide based upon a score of 3 or greater on the Columbia Suicide Severity Scale, unless clinical judgment indicates that the individual is appropriate for inclusion despite these scores.\n3. History of uncontrolled or persistent seizures\n4. Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score \\\u003C 25\n5. Contraindications for MRI:\n\n   1. Presence of implanted electrical stimulation device or other implanted metal devices (excluding dental braces).\n   2. Claustrophobia\n   3. Body weight exceeding limit of the machine (180 kg\u002F400 lb)\n6. Females who are pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test during the pre-op phase and must agree to utilize adequate birth control throughout the trial and for at least 30 days following trial completion.\n7. Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)\n8. Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)\n9. Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI\n10. Any evidence of underlying endocarditis.\n11. Primary language other than English\n12. Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.","22 Years",{"count":150,"type":22},[87],"This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.",[230],[416,417,418],"Deep Brain Stimulation","Addiction","Nucleus Accumbens",{"date":420,"type":35},"2026-06-18",{"date":422,"type":35},"2022-02-07",{"date":424,"type":22},"2030-01",{"name":426,"class":42},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":18,"minAge":435,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":54,"phases":438,"briefSummary":440,"conditions":441,"keywords":443,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":43},"100630258","phase-4-a-bundled-intervention-to-end-opioid-overdoses-100630258","NCT07485335","A Bundled Intervention to End Opioid Overdoses","Implementation and Effectiveness of A Bundled Intervention to End Opioid Overdoses by Increasing Treatment Uptake Post Discharge","B-CARE","Inclusion Criteria:\n\n1. discharged from the ED and inpatient settings at the UAB hospital\n2. 19 years or older (the age of majority in Alabama);\n3. diagnosis of OUD and experiencing opioid overdose in the last 12 months;\n4. prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;\n5. English speaking;\n6. not actively psychotic and suicidal, or cognitively impaired.\n7. Patients who are admitted to the hospital from the ED will be eligible for enrollment.\n\nExclusion Criteria:\n\n1. living in a restricted environment (e.g., prison or jail facility, etc.);\n2. currently enrolled in other clinical studies;\n3. anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months;\n4. known allergic reaction to buprenorphine;\n5. critically ill or injured;\n6. females with pregnancy (they are anticipated to request a higher level of care).\n7. living outside of Alabama","19 Years",{"count":437,"type":22},160,[439],"PHASE4","Opioid overdose deaths have reached historically high records in the United States and are particularly concentrated among patients after emergency department (ED) discharge. Evidence-based treatment modules to reduce repeat opioid overdose and mortality are lacking in this patient population. A bundled intervention is proposed, including telehealth, peer support specialist, buprenorphine, and linkage for definitive care, that is designed to increase treatment uptake in this patient population post-ED discharge, reduce repeat opioid overdoses, and end overdose deaths.",[28,442],"Opioid Overdose",[444,445,140,446,141],"Emergency department","post discharge","peer support specialist","2026-06-16",{"date":420,"type":35},{"date":450,"type":22},"2026-09-07",{"date":452,"type":22},"2030-09-30",{"name":454,"class":42},"University of Alabama at Birmingham",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":54,"phases":464,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":43},"100578043","machine-learning-prediction-and-reducing-overdoses-with-ehr-nudges-100578043","NCT06806163","Machine-Learning Prediction and Reducing Overdoses With EHR Nudges","mPROVEN","Inclusion Criteria:\n\n* Received an opioid prescription within the past year\n* Age 18 years or older at the time of the opioid prescription\n* At least one visit to an internal medicine or family care practice within the past year\n\nExclusion Criteria:\n\n* Diagnosis of malignant cancer within the past year\n* Enrollment in hospice care",{"count":463,"type":22},1350,[87],"The goal of this cluster randomized clinical trial is to test a clinician-targeted behavioral nudge intervention in the Electronic Health Record (EHR) for patients who are identified by a machine-learning based risk prediction model as having an elevated risk for an opioid overdose.\n\nThe clinical trial will evaluate the effectiveness of providing a flag in the EHR to identify individuals at elevated risk with and without behavioral nudges\u002Fbest practice alerts (BPAs) as compared to usual care by primary care clinicians.\n\nThe primary goals of the study are to improve opioid prescribing safety and reduce overdose risk.",[442,467,28,468],"Opioid Use","Opioids",[470,471,472,473,474,475,476,442,468],"Machine learning","Risk prediction","Behavioral nudge","Best Practice Alert","Artificial intelligence","Primary care","Electronic Health Record Platforms",{"date":396,"type":35},{"date":479,"type":35},"2025-03-10",{"date":481,"type":22},"2027-02",{"name":483,"class":42},"University of Pittsburgh",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":292,"enrollmentInfo":491,"targetDuration":4,"studyType":54,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":43},"100495342","phase-1-cannabis-and-opioid-use-disorder-100495342","NCT05729932","Cannabis and Opioid Use Disorder","Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety","Inclusion Criteria:\n\n* Current opioid use disorder\n\nExclusion Criteria:\n\n* Current medical conditions that require medical management",{"count":492,"type":22},15,[114],"This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.",[28],{"date":420,"type":35},{"date":498,"type":35},"2024-09-10",{"date":500,"type":22},"2027-06-30",{"name":309,"class":42},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":82,"sex":18,"minAge":178,"maxAge":179,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":43},"100577623","opioid-use-disorder-and-pain-100577623","NCT06800703","Opioid Use Disorder and Pain","Patients with Opioid Use Disorder (OUD)\n\nTo be eligible for inclusion in the study, an individual must meet all of the following criteria:\n\n1. Between ages 21-60 years old.\n2. Able to read and write and provide written informed consent.\n3. Meet DSM-5 criteria for moderate to severe opioid use disorder; self-reported excessive opioid use prior to study entry and verified by urine toxicology testing; seeking treatment for their OUD.\n4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness\n5. No plans to relocate out of state in the next 12 months (for follow-up purposes).\n6. Currently seeking treatment or currently receiving treatment for OUD.\n7. Speak English\n8. Have been enrolled in an inpatient or outpatient treatment program for OUD for at least 4 weeks.\n\nExclusion Criteria:\n\n1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.\n2. History of head injury with loss of consciousness (\\> 30 minutes).\n3. Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives\u002Fhypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded.\n4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded. Individuals who previously worked in metal industry or with metal shavings (due to a risk of any remaining metal particles moving in the eye during the MRI).\n5. Pregnant or lactating women will not be recruited for the study.\n6. Cannot or are not willing to lie comfortably flat on his\u002Fher back for up to 2 hours in the MRI scanner (self-report).\n7. Body weight \\> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.\n8. No pPlans to relocate out of state in the next 12 months (for follow-up purposes).\n9. Still experiencing significant withdrawal symptoms.\n\nIndividuals with regular opioid use\n\nTo be eligible for inclusion in the study, an individual must meet all of the following criteria:\n\n1. Between ages 21-60 years old.\n2. Able to read and write and provide written informed consent.\n3. Use non-prescribed opioids on a weekly basis or more.\n4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness\n5. No plans to relocate out of state in the next 12 months (for follow-up purposes).\n6. Speak English\n\nExclusion Criteria:\n\n1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.\n2. History of head injury with loss of consciousness (\\> 30 minutes).\n3. Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives\u002Fhypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded.\n4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded.\n5. Pregnant or lactating women will not be recruited for the study.\n6. Cannot or are not willing to lie comfortably flat on his\u002Fher back for up to 2 hours in the MRI scanner (self-report).\n7. Body weight \\> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.\n\nIndividuals with regular opioid use\n\nTo be eligible for inclusion in the study, an individual must meet all of the following criteria:\n\n1. Between ages 21-60 years old.\n2. Able to read and write and provide written informed consent.\n3. Use non-prescribed opioids on a weekly basis or more.\n4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness\n5. No plans to relocate out of state in the next 12 months (for follow-up purposes).\n6. Speak English\n\nExclusion Criteria:\n\n1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.\n2. History of head injury with loss of consciousness (\\> 30 minutes).\n3. Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives\u002Fhypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded.\n4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded.\n5. Pregnant or lactating women will not be recruited for the study.\n6. Cannot or are not willing to lie comfortably flat on his\u002Fher back for up to 2 hours in the MRI scanner (self-report).\n7. Body weight \\> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.\n\nIndividuals with regular opioid use\n\nTo be eligible for inclusion in the study, an individual must meet all of the following criteria:\n\n1. Between ages 21-60 years old.\n2. Able to read and write and provide written informed consent.\n3. Use non-prescribed opioids on a weekly basis or more.\n4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness\n5. No plans to relocate out of state in the next 12 months (for follow-up purposes).\n6. Speak English\n\nExclusion Criteria:\n\n1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.\n2. History of head injury with loss of consciousness (\\> 30 minutes).\n3. Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives\u002Fhypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded.\n4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded.\n5. Pregnant or lactating women will not be recruited for the study.\n6. Cannot or are not willing to lie comfortably flat on his\u002Fher back for up to 2 hours in the MRI scanner (self-report).\n7. Body weight \\> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.\n\nHealthy controls (HC) Inclusion Criteria\n\n1. Between ages 1821-60 years old.\n2. Able to read and write and provide written informed consent.\n3. Demographics matching OUD participants.\n4. Speak English\n\nExclusion Criteria:\n\n1. Meet criteria for current or history of any Axis I (except nicotine use) disorder.\n2. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology. History of head injury with loss of consciousness (\\> 30 minutes).\n\n4\\. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded.\n\n5\\. Pregnant or lactating women will not be recruited for the study. 6. Cannot or are not willing to lie comfortably flat on his\u002Fher back for up to 2 hours in the MRI scanner (self-report).\n\n7\\. Body weight \\> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.",{"count":509,"type":22},180,"The goal of this observational study is to characterize the brain processes of pain avoidance learning dysfunctions in individuals with opioid use disorder (OUD). The main questions it aims to answer are:\n\nCompared with healthy controls, do those with OUD exhibit impaired avoidance learning in response to pain? What are the brain processes that are associated with this avoidance learning dysfunction? Do these brain processes serve to predict future use or relapse?\n\nResearchers will compare those with OUD and healthy controls to determine avoidance learning dysfunction and its relationship with opioid use.\n\nParticipants will be performing a learning task inside an fMRI scanner. Those with OUD will also be followed up for a year to determine future opioid use.",[28,512],"Healthy Controls Group - Age and Sex-matched",[60,514,515,516],"pain","avoidance learning","prediction","2026-06-12",{"date":447,"type":35},{"date":520,"type":35},"2025-02-04",{"date":522,"type":22},"2028-01",{"name":524,"class":42},"Yale University",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":54,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":43},"100490700","phase-4-optimizing-evidence-based-hiv-prevention-targeting-people-who-inject-drugs-on-prep-100490700","NCT05669534","Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP","MOST","Inclusion Criteria:\n\n* being 18 years or older\n* meeting DSM-V criteria for opioid dependence and being newly prescribed and adherent to Medication for Opioid Use Disorder (e.g., methadone, buprenorphine) at the APT Foundation, Inc.\n* showing mild cognitive impairment based on the Montreal Cognitive Assessment (MoCA) screening\n* having initiated Pre-Exposure Prophylaxis (PrEP) within the past week\n* confirming HIV-negative status through proof of PrEP prescription\n* reporting unsafe injection drug use practices or unprotected sex within the past 3 months\n* having a cell phone\n* being able to read and understand in English\n\nExclusion Criteria:\n\n* unable to provide consent\n* actively suicidal\n* actively homicidal\n* actively psychotic\n* display MoCA scores suggestive of dementia",{"count":533,"type":22},256,[439],"The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize HIV prevention content, leading to improvements in HIV prevention information, motivation, behavioral skills, and behaviors (IMB).",[537,28],"Hiv",[539,540,541,542,543,544,60],"people who inject drugs","HIV","cognitive dysfunction","pre-exposure prophylaxis","multiphase optimization strategy","medication for opioid use disorder",{"date":546,"type":35},"2026-06-15",{"date":548,"type":35},"2023-03-01",{"date":550,"type":22},"2027-01-01",{"name":552,"class":42},"University of Connecticut",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":560,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":54,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":239},"100594826","coordinating-outpatient-buprenorphine-for-emergency-care-and-continuing-treatment-100594826","NCT07024498","Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment","CONNECT","Inclusion Criteria:\n\n* patients who start buprenorphine for opioid use disorder at a participating ED","14 Years",{"count":562,"type":22},3492,[87],"The main purpose of this stepped wedge trial will be to test the impact of a bundle of implementation strategies designed to improve ED-outpatient care coordination on long-term buprenorphine retention among adult patients who start buprenorphine for opioid use disorder in a hospital emergency department (ED) and then are referred for continued outpatient buprenorphine treatment after they leave the ED. Our hypothesis is that adopting the bundle of implementation strategies will be associated with subsequent increases in:\n\nA) Cumulative number of days with active buprenorphine prescription at 3, 6, and 12 months after patients' initial ED visit (6 months = primary outcome)\n\nB) Proportion of patients with active buprenorphine prescriptions without gaps in buprenorphine coverage of more than 7 days at 3, 6, and 12 months after patients' initial ED visit\n\nC) Proportion of patients who fill at least 1 outpatient buprenorphine prescription within 30 days of their ED visit\n\nD) Clinician reported quality of ED-outpatient care coordination and care transitions",[28],[139,60,567,568,569,570,140,571],"care coordination","implementation science","hybrid effectiveness-implementation","multiteam systems","stepped wedge","2026-06-10",{"date":517,"type":35},{"date":575,"type":35},"2025-11-01",{"date":577,"type":22},"2029-08-01",{"name":149,"class":42},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":54,"phases":589,"briefSummary":590,"conditions":591,"keywords":592,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":150},"100577501","adaptive-decision-support-for-addiction-treatment-master-100577501","NCT06799117","Adaptive Decision Support for Addiction Treatment Master","Adaptive Decision Support for Addiction Treatment (ADAPT)","ADAPT","Inclusion Criteria:\n\n* Emergency department patient\n* 18 years of age or older\n* Moderate to severe opioid use disorder\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Pregnant\n* Currently receiving medication for opioid use disorder",{"count":588,"type":22},1912,[87],"This study refines and optimizes the EMBED\\* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder.\n\nThis study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases.\n\nOptimization Phase: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED is expanded to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. In Stage 2, investigators will improve CDS usability via serial randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment through identification of specific targets for improvement via application of novel CDS outcome measures in serial randomized tests.\n\nEvaluation phase: Investigators will conduct a randomized trial to compare the efficacy effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.\n\n\\*EMBED is a user user-centered, clinician clinician-facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community",[28],[593,594],"Opioid use disorder","Clinical Decision Support",{"date":596,"type":35},"2026-06-11",{"date":598,"type":35},"2025-03-21",{"date":600,"type":22},"2028-03-31",{"name":524,"class":42},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":82,"sex":18,"minAge":19,"maxAge":292,"enrollmentInfo":609,"targetDuration":4,"studyType":54,"phases":611,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":622,"locationsCount":43},"100643124","early-phase-1-safety-tolerability-and-pharmacokinetics-of-mcam-in-healthy-adult-participants-100643124","NCT07602335","Safety, Tolerability, and Pharmacokinetics of MCAM in Healthy Adult Participants","A Phase 1, First-In-Human, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of MCAM in Randomized Healthy Adult Participants (Double-Blind)","Inclusion Criteria:\n\n1. Is willing and able to provide informed consent and comply with all protocol requirements\n2. Is aged ≥18 years and ≤55 years at time of informed consent\n3. Has a body mass index (BMI) between 18.0 and 32.0 kg\u002Fm2 and body weight (BW) not lower than 50 kg\n4. Participant is a nonsmoker (for at least 3 months prior to Screening) and does not use tobacco-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum)\n5. Has Blood pressure (BP) and Heart rate (HR) within the normal range at the Screening visit after 5 minutes in a seated position:\n\n   1. Systolic BP between 90 and 145 mmHg\n   2. Diastolic BP between 60 and 90 mmHg\n   3. HR between 60 and 90 beats per minute\n6. Electrocardiogram (ECG) is normal based on 12-lead ECG assessment at Screening:\n\n   1. ECG PR interval between 120 and 200 ms\n   2. ECG QRS interval \\\u003C100 ms\n   3. ECG QT interval (corrected) (QTc) with Fridericia formula (QTcF) \\\u003C450 ms and no history of additional risk factors for Torsades de pointes (TdP)\n   4. No sign of any sinus node dysfunction\n7. Has clinical laboratory parameters (hematology \\[including coagulation\\], clinical chemistry, and urinalysis) within normal ranges. Individual values out of the normal range may be acceptable if judged clinically insignificant by an Investigator.\n8. Has not been dosed in an interventional clinical drug trial within 30 days prior to screening or within 5 half-lives of the last dose of study drug, whichever is longer.\n9. If female, participants who are not of childbearing potential should be surgically sterile (e.g., have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation\u002Focclusion) or in a post-menopausal state (at least one year without menses). Female participants of childbearing potential will use a highly effective (i.e., failure rate of \\\u003C1%) method of contraception throughout the study and for at least five half-lives following MCAM dosing. Methods of contraception that are considered to be highly effective with a failure rate of \\\u003C1% that are appropriate for this study include the following: a) intrauterine device (IUD)\u002Fintrauterine system (IUS); b) implantable rod; c) bilateral tubal occlusion; d) complete abstinence from sexual intercourse; and e) infertile male partner (e.g., vasectomized \\[with documented evidence of azoospermia\\], permanently sterile following bilateral orchidectomy, or any other documented cause of infertility).\n10. If female, must have a negative serum or urine pregnancy test at Screening and a negative serum or urine test at Admission (day 1)\n11. Male participants who report surgical sterilization will be required to confirm sterility by post-vasectomy semen analysis (PVSA). Participants in whom PVSA confirmation cannot be obtained will be required to use a double-barrier method (e.g., condom with spermicide), same as for the rest of the male participants, or agree to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for at least five half-lives following MCAM dosing.\n12. If male, participants must agree not to donate sperm for the duration of the study and for 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Any significant acute or chronic medical illness\n2. Any history of cancer within 5 years of enrollment, with the exception of fully resected skin basal cell carcinoma\n3. Any major hospitalization or surgery 3 months prior to study drug administration\n4. Has donated or experienced a blood loss of 500 mL or more within 56 days prior to Screening or has donated plasma within 7 days prior to Screening\n5. Poor venous access assessed at Screening\n6. Has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence. If participation in a rehabilitation program was court-mandated as part of a plea agreement, entry may be permissible at an Investigator's discretion\n7. Any history of substance use disorder) as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5; e.g. a score of ≥2, within a 12-month period) or recent use of an opioid-containing product (e.g., codeine) within 6 months prior to study drug administration\n8. History of, or currently diagnosed with, any clinically significant psychiatric disorder (based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition \\[DSM-5\\] and Mini International Neuropsychiatric Interview \\[MINI\\] criteria), which in the opinion of an Investigator could interfere with study participation or study data collection\n9. History of any suicidal ideation within the past 6 months or a lifetime history of suicidal behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)\n10. Any neurological, renal, cardiac, hepatic, or other medical condition that could interfere with study assessments as determined by and Investigator, or Sponsor\n11. Any significant illness or infection, as determined by an Investigator or Sponsor, within the prior 30 days\n12. Positive urine alcohol or urine drug screen for substance of abuse at Screening\n13. Must not be physically dependent on opioids, as demonstrated by successful completion of the naloxone challenge\n14. Known hypersensitivity to any component of the MCAM drug product, naloxone, or placebo\n15. Use of any prescription or over-the-counter medications (such as antacids, vitamins, minerals, dietary\u002Fherbal preparations, St. John's Wort, and nutritional supplements) within 14 days prior to Screening or 5 half-lives prior to the study\n16. Positive screen for hepatitis B surface antigen (HBsAg), Hepatitis C (HCV) antibody, or HIV-1 and HIV-2 antibodies\n17. Have a procedure planned that would require the use of opioids for pain management within at least 2 weeks after the conclusion of the study (participants may be resistant to opioids for two weeks or longer after study participation)\n18. Is likely, in the opinion of an Investigator, to be non-compliant or uncooperative with study procedures for any reason\n19. If female, are pregnant, nursing, or planning to become pregnant during the study",{"count":610,"type":22},24,[369],"The goal of this clinical trial is to test the safety and to see if there are any side effects of the investigational drug, MCAM. The main aim is to measure blood levels of the study drug after oral administration.\n\nResearchers will compare the active study drug to a placebo to test for any differences between the two groups.\n\nParticipants will be screened for up to 28 days before starting study treatment. Following the screening visit, participants will be admitted to a clinic for 4 days for treatment with either the study drug or placebo. They will attend a follow-up visit on Days 5 and 7 and participate in a follow-up phone call on Day 8. Three different doses will be tested to find the highest safe dose.",[28],[615,616],"Healthy participants","μ-Opioid Receptor","2026-06-08",{"date":596,"type":35},{"date":620,"type":22},"2026-08-08",{"date":235,"type":22},{"name":623,"class":42},"The University of Texas Health Science Center at San Antonio"]