[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539638":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":55,"studyPopulation":48,"armGroups":56,"interventions":68,"overallOfficials":48,"centralContacts":74,"locations":84,"responsibleParty":111,"collaborators":48,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":48,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":48,"enrollmentInfo":123,"targetDuration":48,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":48,"overallStatus":87,"whyStopped":48,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Friends Research Institute, Inc.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":48},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"urine toxicology","positive urine drug screen for opioids","12-months",{"measure":14,"description":15,"timeFrame":12},"days of opioid use","Number of days since last assessment",{"measure":17,"description":18,"timeFrame":12},"time to opioid relapse","days from release from jail to first relapse event",[20,24,27,30,33,36,39,42,45],{"measure":21,"description":22,"timeFrame":23},"retention in buprenorphine treatment","days receiving buprenorphine","6-months",{"measure":25,"description":26,"timeFrame":12},"urine toxicology for other illicit substance use","positive urine drug screen",{"measure":28,"description":29,"timeFrame":12},"days of illicit substance use","number of days since last assessment",{"measure":31,"description":32,"timeFrame":12},"overdose events","fatal and non-fatal overdose events",{"measure":34,"description":35,"timeFrame":12},"PROMIS Patient-Reported Outcomes Measurement Information System - physical health","Global physical health score",{"measure":37,"description":38,"timeFrame":12},"PROMIS Patient-Reported Outcomes Measurement Information System - mental health","Global mental health score",{"measure":40,"description":41,"timeFrame":12},"HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score","sexual risk behavior; Scored 0-18 (higher risk)",{"measure":43,"description":44,"timeFrame":12},"HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score","needle use or sharing; Scored 0-22 (higher risk)",{"measure":46,"description":47,"timeFrame":12},"criminal activity","i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":48},"NONE","This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.\n\nAim 1. Compare the effectiveness of XR-B vs. SL-B Aim 2. To calculate the cost to the state and\u002For jail\u002Fcity health system of implementing XR-B and SL-B, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective.\n\nAim 3. Explore barriers and facilitators to XR-B versus SL-B implementation in jail: (1) dose induction; (2) diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another facility; (4) staffing (both custody and medical) needs for daily versus XR-B buprenorphine dosing; and (5) patient preference for XR-B versus SL-B.\n\nPrimary Outcome. (a) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use using Timeline Followback; and iii. time to opioid relapse).\n\nSecondary Outcomes. (b) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use using Timeline Followback; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration).\n\nCosts. (a) cost to the correctional system; (b) costs associated with community intervention",[57,63],{"label":58,"type":59,"description":60,"interventionNames":61},"extended-release buprenorphine (XR-B)","EXPERIMENTAL","Participants will receive sublingual (sl; taken under the tongue) buprenorphine\u002Fnaloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine\u002Fnaloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine\u002Fnaloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.",[62],"Drug: extended-release buprenorphine (XR-B)",{"label":64,"type":65,"description":66,"interventionNames":67},"sublingual buprenorphine (SL-B)","ACTIVE_COMPARATOR","Participants will receive sublingual (sl; taken under the tongue) buprenorphine\u002Fnaloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine\u002Fnaloxone.",[62],[69],{"type":70,"name":58,"description":71,"armGroupLabels":72,"otherNames":73},"DRUG","buprenorphine",[58,64],[64],[75,81],{"name":76,"role":77,"phone":78,"phoneExt":79,"email":80},"Michael Gordon, DPA","CONTACT","4108373977","251","mgordon@friendsresearch.org",{"name":82,"role":77,"phone":78,"phoneExt":48,"email":83},"Thomas R Blue, PhD","tblue@friendsresearch.org",[85,102],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Friends Research Institute","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":94,"coordinates":95},"Point",[96,97],-76.61219,39.29038,{"lat":97,"lon":96},[100],{"name":101,"role":77,"phone":78,"phoneExt":48,"email":80},"Michael Gordon",{"facility":103,"status":87,"city":88,"state":89,"zip":104,"country":91,"countryCode":92,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Baltimore Central Booking & Intake Center","21202",{"type":94,"coordinates":106},[96,97],{"lat":97,"lon":96},[109,110],{"name":76,"role":77,"phone":78,"phoneExt":79,"email":80},{"name":82,"role":77,"phone":78,"phoneExt":48,"email":83},{"type":112,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100539638","phase-3-buprenorphine-for-individuals-in-jail-100539638",false,"NCT06306443","Buprenorphine for Individuals in Jail","A Comparative Effectiveness Trial of Sublingual Versus Extended-release Buprenorphine With Individuals Leaving a Carceral Setting","Inclusion Criteria:\n\n* Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and\u002For pretrial \\[note: individuals who might be sentenced to state\u002Ffederal prison will be excluded\\]); Those individuals who are pre-trial and\u002For sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court \\[or equivalent\\]) will be eligible to participate;\n* History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration);\n* Suitability for XR-B and\u002For SL-B treatment as determined by medical evaluation;\n* Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community;\n* Planning to live in Baltimore City or the Baltimore Region;\n\nExclusion Criteria:\n\n* Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion);\n* Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable);\n* Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant);\n* Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed);\n* History of allergic reaction to buprenorphine;\n* Suicidal ideation (within the past 6 months);\n* Inability to pass a study enrollment quiz; and\n* Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone).",true,"ALL","18 Years",{"count":124,"type":125},240,"ESTIMATED","INTERVENTIONAL",[128],"PHASE3","This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.",[131],"Opioid Use Disorder","2026-06-02",{"date":134,"type":135},"2026-06-04","ACTUAL",{"date":137,"type":135},"2025-06-20",{"date":139,"type":125},"2029-04-30",{"name":5,"class":6},2]