[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474553":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":38,"locations":43,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":26,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment as Usual (TAU)","ACTIVE_COMPARATOR","Participants in treatment as usual group will receive 100% active methadone in AM + placebo in PM.",[13],"Drug: Methadone (100% dose)",{"label":15,"type":16,"description":17,"interventionNames":18},"Split-dosing","EXPERIMENTAL","Participants in split dosing group will receive 50% active methadone + placebo twice daily.",[19],"Drug: Methadone (50% dose)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methadone (100% dose)","Methadone for the treatment of opioid use disorder",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Methadone (50% dose)",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Kelly E Dunn, PhD, M.B.A.","University of Maryland","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Denis Antoine, MD","Johns Hopkins University",[39],{"name":32,"role":40,"phone":41,"phoneExt":26,"email":42},"CONTACT","802-922-1682","kelly.dunn@som.umaryland.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Addiction Treatment Services (ATS)","RECRUITING","Baltimore","Maryland","21224","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-76.61219,39.29038,{"lat":56,"lon":55},[59],{"name":36,"role":40,"phone":26,"phoneExt":26,"email":26},{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[63],{"name":64,"class":65},"National Institute on Drug Abuse (NIDA)","NIH","100474553","phase-2-divided-or-single-exposure-dose-study-100474553",false,"NCT05459402","Divided or Single Exposure (DOSE) Study","Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment","Inclusion Criteria:\n\n* Aged 18 years of age or older\n* Currently receiving methadone for treatment of OUD for \\>90 days and have been consuming the same dose for \\>30 days\n* Have previously received a take-home dose of methadone as part of routine care\n* Willing to comply with study schedule\n* Report pain (specific definition blinded)\n* Have a cellular phone or be willing to carry phone provided by the study during one phase of the study\n\nExclusion Criteria:\n\n* Pregnant\n* Presence of acute medical problem that requires immediate and intense medical management\n* Presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and\u002For adherence to study visits\n* Plans to leave methadone treatment during the study period\n* Maintained on a dose of methadone that would prevent effective splitting of doses\n* Currently receiving split doses of methadone\n* Currently receiving treatment for pain for which the split-dosing of methadone is judged by medical staff to be contraindicated or otherwise interfere with study conduct or integrity\n* Does not meet criteria for mild-severe disability (definition blinded)","ALL","18 Years","100 Years",{"count":77,"type":78},150,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE2","PHASE3","This study will evaluate whether once versus twice daily dosing of methadone will be an effective method for managing comorbid pain and opioid use disorder.",[85,86,87],"Opioid Use Disorder","Chronic Pain","Methadone","2026-01-30",{"date":90,"type":91},"2026-02-03","ACTUAL",{"date":93,"type":91},"2023-02-21",{"date":95,"type":78},"2028-06-01",{"name":5,"class":6},1]