[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100391602":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":62,"studyPopulation":62,"armGroups":75,"interventions":88,"overallOfficials":98,"centralContacts":103,"locations":113,"responsibleParty":171,"collaborators":173,"id":177,"slug":62,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":62,"eligibilityCriteria":182,"healthyVolunteers":178,"sex":183,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":62,"studyType":189,"phases":190,"briefSummary":192,"conditions":193,"keywords":62,"overallStatus":116,"whyStopped":62,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":62},[9],{"measure":10,"description":11,"timeFrame":12},"Change in drug use from baseline.","American Pain Foundation Pain\u002FMedication Diary is used to monitor Drug Use overtime after stimulation for approximately 6 weeks.","Measured for approximately 6 weeks",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59],{"measure":15,"description":16,"timeFrame":12},"Changes in the Verbal Rating Scale (VRS) for Pain","Changes in VRS for Pain will be measured in order to determine if tDCS + ESSTIM is effective in reducing the pain of subjects with Chronic Pain (CP) and Opioid Use Disorder(OUD) when compared to the SHAM group.Verbal Rating Scale (VRS) for Pain is a categorical scale of pain with categories: none, mild, moderate, severe pain intensity.",{"measure":18,"description":19,"timeFrame":12},"Changes in pain as measured by the Visual Analog Scale (VAS)","Changes in VAS for Pain will be measured in order to determine if tDCS + ESSTIM is effective in reducing the pain of subjects with Chronic Pain (CP) and Opioid Use Disorder(OUD) when compared to the SHAM group.Visual Analog Scale (VAS) for Pain will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable).",{"measure":21,"description":22,"timeFrame":12},"Safety measures","The investigators will measure safety through a standardized neurological exam, which will include the assessment of cognitive domains including memory, attention, mood (scaled as normal or abnormal).",{"measure":24,"description":25,"timeFrame":12},"Study 36-Item Short Form (SF-36)","This is a health survey using a scale from 0 (worst) to 100 (best)",{"measure":27,"description":28,"timeFrame":12},"Patient Health Questionnaire (PHQ-9)","This questionnaire screens for depression with a score of 0 (best) to 27 (worst)",{"measure":30,"description":31,"timeFrame":12},"Electroencephalography (EEG) recording:","previous: EEG recording: On the first baseline visit, on the first day of Week 1, at the end of each stimulation week, and at the follow up visits. EEG recordings will be taken to monitor changes in power in different frequency bands including (theta, alpha, beta and gamma) for 20 min.",{"measure":33,"description":34,"timeFrame":12},"Ultimatum Game:","This task evaluates reward, salience and executive network behavioral correlates",{"measure":36,"description":37,"timeFrame":12},"Risk Task:","The task is designed to analyze the relationship between prediction and reward (and penalty) is associated with the choice of the least likely outcome, and the smallest reward (and penalty).",{"measure":39,"description":40,"timeFrame":12},"Inhibitory Control Task:","We will assess the interaction between reward processing (via the presence or absence of reward) and mechanisms of inhibitory control.",{"measure":42,"description":43,"timeFrame":12},"Opioid Cue-Exposure Task for Craving Assessment:","A set of randomized videos showing scenes of people using opioids will aid assessment of craving.",{"measure":45,"description":46,"timeFrame":12},"Hair follicle drug test","A hair follicle drug test screens for illicit drug use and the misuse of prescription medication. The sample is then analyzed for signs of drug use over 90 days. The results will be measured as positive or negative.",{"measure":48,"description":49,"timeFrame":12},"National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST)","Clinician's Screening Tool for Drug Use in General Medical Settings which implements a scale from 0-3 \"Low Risk\", 3-26 \" Moderate Risk\", and 27+ \"High Risk\"",{"measure":51,"description":52,"timeFrame":12},"Obsessive-Compulsive Drinking\u002FDrug Use Scale (OCDS)","This measure reflects obsessionality and compulsivity related to craving and drinking behavior with a total score ranging from 0 to 64 (with 64 being the worst).",{"measure":54,"description":55,"timeFrame":12},"15-item Barrett Impulsivity scale","15-item Barrett Impulsivity scale is used to measure impulsivity with a total score ranging from 15 to 60 (with 15 lower level of impulsivity and 60 higher levels of impulsivity.",{"measure":57,"description":58,"timeFrame":12},"National Institute on Drug Abuse (NIDA) Quick Screen","The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use which has a yes\u002Fno scale (with \"no\" being best and \"yes\" being worse)",{"measure":60,"description":61,"timeFrame":12},"Urine drug test","A Urine drug test screens for illicit drug use and the misuse of prescription medication. The sample is then analyzed for signs of drug use during the past few days. The results will be measured as positive or negative.",null,{"allocation":64,"interventionModel":65,"interventionModelDescription":66,"primaryPurpose":67,"observationalModel":62,"timePerspective":62,"maskingInfo":68},"RANDOMIZED","PARALLEL","single-center, double-blinded, placebo controlled, randomized study.","TREATMENT",{"masking":69,"maskingDescription":70,"whoMasked":71},"TRIPLE","Triple",[72,73,74],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[76,82],{"label":77,"type":78,"description":79,"interventionNames":80},"Active (tDCS) + Active TUS","ACTIVE_COMPARATOR","Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)",[81],"Device: Active Comparator: Active tDCS + Active TUS",{"label":83,"type":84,"description":85,"interventionNames":86},"Sham (tDCS) + Sham TUS","SHAM_COMPARATOR","Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).",[87],"Device: Sham Comparator: Sham tDCS + Sham TUS",[89,94],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":62},"DEVICE","Active Comparator: Active tDCS + Active TUS","Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes.\n\nDevice: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.",[77],{"type":90,"name":95,"description":96,"armGroupLabels":97,"otherNames":62},"Sham Comparator: Sham tDCS + Sham TUS","Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes.\n\nDevice: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.",[83],[99],{"name":100,"affiliation":101,"role":102},"Ciro R Estebanez, MD PhD","University Hospitals Cleveland Medical Center\u002F Case Western Reserve University","PRINCIPAL_INVESTIGATOR",[104,109],{"name":105,"role":106,"phone":107,"phoneExt":62,"email":108},"Kimberly Bass, RN","CONTACT","216-286-7250","kimberly.bass@uhhospitals.org",{"name":110,"role":106,"phone":111,"phoneExt":62,"email":112},"Mario Becerra, RN","216-844-1734","Mario.Becerra@UHHospitals.org",[114,136,154],{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"University of Illinois Health\u002F University of Illinois at Chicago","RECRUITING","Hinsdale","Illinois","60612","United States","US",{"type":123,"coordinates":124},"Point",[125,126],-87.93701,41.80086,{"lat":126,"lon":125},[129,132,135],{"name":130,"role":106,"phone":62,"phoneExt":62,"email":131},"Ming-Chieh Shun, PhD","mshun@uic.edu",{"name":133,"role":106,"phone":62,"phoneExt":62,"email":134},"Ciro Ramos Estebanez, MD, PhD","cramoses@icloud.com",{"name":133,"role":102,"phone":62,"phoneExt":62,"email":62},{"facility":137,"status":116,"city":138,"state":139,"zip":140,"country":120,"countryCode":121,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center","Cambridge","Massachusetts","02138",{"type":123,"coordinates":142},[143,144],-71.10561,42.3751,{"lat":144,"lon":143},[147,151],{"name":148,"role":106,"phone":149,"phoneExt":62,"email":150},"Elly Pichardo, MD","617-952-6158","epichardo@mgb.org",{"name":152,"role":106,"phone":62,"phoneExt":62,"email":153},"Felipe Fregni, MD, PhD","Fregni.Felipe@mgh.harvard.edu",{"facility":155,"status":116,"city":156,"state":157,"zip":158,"country":120,"countryCode":121,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"University Hospitals Cleveland Medical Center\u002F Dahms Clinical Research Unit","Cleveland","Ohio","44106-1716",{"type":123,"coordinates":160},[161,162],-81.69541,41.4995,{"lat":162,"lon":161},[165,169],{"name":166,"role":106,"phone":167,"phoneExt":62,"email":168},"Salim Hayek, MD","216-983-2085","salim.hayek@uhhospitals.org",{"name":170,"role":106,"phone":62,"phoneExt":62,"email":134},"Ciro R Estebanez, MD, PhD",{"type":172,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR",[174],{"name":175,"class":176},"Highland Instruments, Inc.","INDUSTRY","100391602",false,"NCT04379115","Optimization of NIBS for Treatment of Addiction","Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction","Inclusion Criteria\n\nParticipants must meet all of the following:\n\n* Provide informed consent\n* Age 18-85 years\n* Diagnosis of opioid use disorder (DSM-5) with ongoing non-prescription opioid use confirmed by self-report and urine toxicology\n* Report current opioid craving\n* Enrolled in a certified Opioid Treatment Program and receiving methadone maintenance treatment\n* Stable methadone dose prior to enrollment\n* Reside locally with no plans to relocate during the study Exclusion Criteria\n\nParticipants will be excluded if they:\n\n* Are pregnant\n* Have frequent illicit stimulant use or acute stimulant intoxication\n* Are using substances or medications that may interfere with study assessments (e.g., stimulant medications, buprenorphine-based therapies, naltrexone)\n* Have significant neurological conditions (e.g., stroke, epilepsy, brain tumor), abnormal EEG findings, history of brain surgery, significant head injury, or unexplained syncope\n* Have contraindications to noninvasive brain stimulation (e.g., metal in the head, implanted brain devices)\n* Have moderate to severe depression or active suicidal ideation\u002Fbehavior\n* Have active malignancy\n* Consume substances that could confound opioid toxicology results (e.g., poppy-seed products)","ALL","18 Years","85 Years",{"count":187,"type":188},126,"ESTIMATED","INTERVENTIONAL",[191],"NA","The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.",[194,195],"Opioid-use Disorder","Chronic Pain","2026-03-03",{"date":198,"type":199},"2026-03-04","ACTUAL",{"date":201,"type":199},"2021-04-04",{"date":203,"type":188},"2027-10-31",{"name":5,"class":6},3]