[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440128":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":82,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":41,"studyType":102,"phases":103,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"New York State Psychiatric Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Buprenorphine-naloxone","EXPERIMENTAL","Buprenorphine\u002Fnaloxone 5.7 mg \u002F1.4 mg\u002Fday sub-lingual tablets",[13],"Drug: Buprenorphine\u002Fnaloxone",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","placebo sub-lingual tablet",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Buprenorphine\u002Fnaloxone","5.7 mg buprenorphine\u002F1.4 mg naloxone sub-lingual daily",[9],[27],"Zubsolv",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"placebo sub-lingual tablet daily",[15],[32],"PBO",[34],{"name":35,"affiliation":5,"role":36},"Adam Bisaga, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","646-774-6155",null,"amb107@columbia.edu",{"name":44,"role":39,"phone":41,"phoneExt":41,"email":45},"Onumara Opara, MPH","onumara.opara@nyspi.columbia.edu",[47,72],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Avery Road Treatment Center (ARTC)","RECRUITING","Rockville","Maryland","20853","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-77.15276,39.084,{"lat":59,"lon":58},[62,66,70],{"name":63,"role":39,"phone":64,"phoneExt":41,"email":65},"Praveena Machineni","240-739-0626","PMachineni@marylandtreatment.org",{"name":67,"role":39,"phone":68,"phoneExt":41,"email":69},"Lauren Rudin","240-739-0601","LRudin@marylandtreatment.org",{"name":71,"role":36,"phone":41,"phoneExt":41,"email":41},"Kevin Wenzel, PhD",{"facility":73,"status":74,"city":75,"state":75,"zip":76,"country":53,"countryCode":54,"cosmosGeoPoint":77,"geoPoint":81,"contacts":41},"Stars\u002FNyspi","TERMINATED","New York","10019",{"type":56,"coordinates":78},[79,80],-74.00597,40.71427,{"lat":80,"lon":79},{"type":36,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Adam Bisaga","Psychiatrist",[86],{"name":87,"class":88},"National Institute on Drug Abuse (NIDA)","NIH","100440128","phase-2-efficacy-of-buprenorphine-and-xr-naltrexone-combination-for-relapse-prevention-in-opioid-use-disorder-100440128",false,"NCT05011266","Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder","COMBO","Inclusion Criteria:\n\n* Individuals between the ages of 18-65 (inclusive) interested in antagonist-based relapse prevention treatment\n* Meets current DSM-5 criteria for current opioid use disorder of at least six months duration supported by urine toxicology positive for opioids OR positive naloxone challenge (defined by 3-point increase in COWS) if seeking detoxification and XR-NTX induction OR confirmed recent detoxification treatment for opioids.\n* In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) with no clinically significant abnormalities\n* Participants who completed detoxification and received XR-NTX are eligible for the study. Participants may be enrolled up to 2 weeks following an initial XR-NTX injection given in any outside research or community-based treatment setting (inpatient, outpatient residential).\n* Seeking treatment for opioid use disorder, willing to accept treatment with XR-NTX and, in the judgment of the treating physician, is a good candidate for naltrexone-based treatment.\n* Voluntarily seeking treatment for opioid use disorder.\n* Able to give written informed consent to participate in the study and showing a thorough understanding of the difference between agonist and antagonist-based treatment.\n\nExclusion Criteria:\n\n* Methadone maintenance within 2 weeks of XR-NTX induction or any use of methadone in the week prior to XR-NTX induction\n* Maintenance on buprenorphine or frequent buprenorphine use in the week prior to XR-NTX induction (must be using no more than 8 mg of buprenorphine per day for no more than 3 days per week). If consenting after initial XR-NTX injection, any use of buprenorphine since XR-NTX induction is exclusionary.\n* Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make a detoxification and naltrexone initiation, or maintenance treatment with XR-NTX in combination with buprenorphine, hazardous (relative contraindications) or requires a different level of care. Examples include:\n\n  1. Disabling or terminal medical illness (e.g., uncompensated heart failure, severe acute hepatitis, cirrhosis or end-stage liver disease) as assessed by medical history and\u002For review of systems.\n  2. Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and\u002For clinical interview.\n  3. 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  4. Suicidal or homicidal\n* AST\u002FALT \\> 3x normal limit\n* Pregnancy, lactation, or a plan of becoming pregnant. Women need to have negative blood pregnancy test at screening and agree to practice dual contraceptives.\n* Physiological dependence on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.\n* History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.\n* Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.\n* Individuals above 60 with possible early cognitive decline or other neurodegenerative conditions as evidenced by a score of less than 25 on a Mini Mental Status Exam screen.\n* Participants who had 30 or more opioid-free days prior to randomization will not be eligible.\n* Participants more than 2 weeks following an initial XR-NTX injection (given in any outside research or community-based treatment setting, for example inpatient, outpatient residential).","ALL","18 Years","65 Years",{"count":100,"type":101},180,"ESTIMATED","INTERVENTIONAL",[104,105],"PHASE2","PHASE3","This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections.",[108],"Opioid-use Disorder",[110,111,112,113],"opioid use disorder","treatment","buprenorphine","extended release naltrexone","2026-05-15",{"date":116,"type":117},"2026-05-19","ACTUAL",{"date":119,"type":117},"2023-04-18",{"date":121,"type":101},"2027-01-01",{"name":5,"class":6},2]