[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657647":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":16,"armGroups":28,"interventions":41,"overallOfficials":16,"centralContacts":49,"locations":55,"responsibleParty":71,"collaborators":16,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":16,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":16,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":16,"overallStatus":94,"whyStopped":16,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Kentucky","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Depressive Symptom Severity","Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline, comparing participants receiving transcranial magnetic stimulation (TMS) with those receiving Shame TMS. Higher scores indicate greater depressive symptom severity. The HDRS-17 ranges from 0-52.","Baseline through Week 13",{"measure":14,"description":15,"timeFrame":12},"Change in Opioid Craving","Change in opioid craving as measured by the Opioid Craving Scale (OCS) from baseline, comparing participants receiving the TMS with those receiving sham TMS. The OCD consists of three items rated 0 to 10, with the total score calculated as the average of the three items. A higher score indicates greater opioid craving.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":23},"QUADRUPLE",[24,25,26,27],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Transcranial Magnetic Stimulation (TMS)","EXPERIMENTAL","Participants will receive active transcranial magnetic stimulation (TMS) using intermittent theta burst stimulation (iTBS).",[34],"Device: Transcranial Magnetic Stimulation (TMS)",{"label":36,"type":37,"description":38,"interventionNames":39},"Sham Transcranial Magnetic Stimulation (TMS)","SHAM_COMPARATOR","Participants will receive sham transcranial magnetic stimulation (TMS) using the same treatment procedure without a significant electric field induced around the brain.",[40],"Device: Sham Transcranial Magnetic Stimulation (TMS)",[42,46],{"type":43,"name":30,"description":44,"armGroupLabels":45,"otherNames":16},"DEVICE","Intermittent theta burst stimulation (iTBS) delivered over the left dorsolateral prefrontal cortex using a TMS coil.",[30],{"type":43,"name":36,"description":47,"armGroupLabels":48,"otherNames":16},"Sham Transcranial Magnetic Stimulation (TMS) delivered using the same procedure as active TMS without a significant electric field induced around the brain.",[36],[50],{"name":51,"role":52,"phone":53,"phoneExt":16,"email":54},"Gopalkumar Rakesh, MD","CONTACT","8592576402","Gopalkumar.Rakesh@uky.edu",[56],{"facility":5,"status":16,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Lexington","Kentucky","40506","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-84.47772,37.98869,{"lat":66,"lon":65},[69],{"name":51,"role":52,"phone":70,"phoneExt":16,"email":54},"8592579402",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Gopalkumar Rakesh","Associate Professor","100657647","helping-kentuckians-overcome-depression-and-opioid-addiction-with-brain-stimulation-100657647",false,"NCT07842601","Helping Kentuckians Overcome Depression and Opioid Addiction With Brain Stimulation","Inclusion Criteria:\n\n* 18-75 years of age\n* Willing and able to provide informed consent\n* Able to read and speak english\n* Opioid use disorder, in remission for at least a month\n* Diagnosis of major depressive disorder confirmed with the Mini-International Neuropsychiatric Interview (MINI, 7.02)\n* Minimum score of 10 on the 17-item Hamilton Depression Rating Scale (HDRS-17)\n* Opioid craving score of 5 or greater on a 0-10 scale\n* Stabilized on sublingual or depot buprenorphine for at least 8 weeks\n\nExclusion Criteria:\n\n* Seizure disorder\n* any other acute medical or behavioral disorder that would preclude safe participation\n* Pregnant, nursing or planning to become pregnant during the study\n* Magnetic resonance imaging (MRI) contraindications, including ferrous retainers, intracranial implants, or claustrophobia\n* Surgical procedure planned during the study period\n* Any other medical condition that could compromise participant well-being","ALL","18 Years","75 Years",{"count":85,"type":86},60,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study will compare transcranial magnetic stimulation (TMS) with sham TMS in people with opioid use disorder who are taking buprenorphine and have major depressive disorder with ongoing depressive symptoms. The study will evaluate whether TMS improves depressive symptoms and reduces opioid craving. The study will also assess smoking behaviors, treatment acceptability, and any side effects related to TMS.",[92,93],"Opioid Use Disorder","Major Depressive Disorder (MDD)","NOT_YET_RECRUITING","2026-09-21",{"date":97,"type":98},"2026-09-25","ACTUAL",{"date":100,"type":86},"2026-10-15",{"date":102,"type":86},"2028-12-31",{"name":5,"class":6},1]