[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100389684":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":73,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":36,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":36,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NAc DBS","EXPERIMENTAL","Subjects will receive bilateral DBS of the NAc",[13],"Device: DBS of the NAc",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","DBS of the NAc","Deep Brain Stimulation of the Nucleus Accumbens",[9],[21,22,23,24,25,26],"Abbott Infinity DBS lead, model 6173ANS","Abbott Infinity DBS extension, model 6371ANS","Abbott Infinity DBS implantable pulse generator, model 6660ANS","Abbott Infinity DBS guardian burr hole cap, model 6010ANS","Abbott Infinity DBS patient controller, model 6883ANS","Abbott Infinity DBS clinician programmer, model 3872ANS",[28],{"name":29,"affiliation":30,"role":31},"Nestor Tomycz, MD","Allegheny Health Network","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","412-359-6200",null,"nestor.tomycz@ahn.org",{"name":39,"role":34,"phone":35,"phoneExt":36,"email":40},"Donald Whiting, MD","donald.whiting@ahn.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"AHN Allegheny General Hospital","RECRUITING","Pittsburgh","Pennsylvania","15212","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-79.99589,40.44062,{"lat":54,"lon":53},[57,60,61,63,65,67,69,71],{"name":58,"role":34,"phone":36,"phoneExt":36,"email":59},"Clinical Trials Contact","clinicaltrials@ahn.org",{"name":29,"role":31,"phone":36,"phoneExt":36,"email":36},{"name":39,"role":62,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"name":64,"role":62,"phone":36,"phoneExt":36,"email":36},"Carol Schramke, PhD",{"name":66,"role":62,"phone":36,"phoneExt":36,"email":36},"Amanda Webb, PA",{"name":68,"role":62,"phone":36,"phoneExt":36,"email":36},"Stuart Fisk, CRNP",{"name":70,"role":62,"phone":36,"phoneExt":36,"email":36},"Heather Richards, MD",{"name":72,"role":62,"phone":36,"phoneExt":36,"email":36},"Elizabeth Cuevas, MD",{"type":31,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Nestor Tomycz","Principal Investigator",[77],{"name":78,"class":79},"Abbott","INDUSTRY","100389684","deep-brain-stimulation-effects-in-patients-with-opioid-use-disorder-100389684",false,"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.","ALL","22 Years","65 Years",{"count":91,"type":92},3,"ESTIMATED","INTERVENTIONAL",[95],"NA","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.",[98],"Opioid-use Disorder",[100,101,102],"Deep Brain Stimulation","Addiction","Nucleus Accumbens","2026-06-17",{"date":105,"type":106},"2026-06-18","ACTUAL",{"date":108,"type":106},"2022-02-07",{"date":110,"type":92},"2030-01",{"name":5,"class":6},1]