[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06051890":3,"trial-entities:NCT06051890":125,"trial-summary:NCT06051890":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":42,"secondary_outcomes":47,"sex":52,"minimum_age":17,"maximum_age":17,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":66,"locations":70,"central_contacts":115,"overall_officials":120,"references":123,"see_also_links":124},"NCT06051890","23-00926","Assessing Optimal XRB Initiation Points in Jail","Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail","RECRUITING","2027-03-01","2026-08","2026-08-07","2025-06-02","NYU Langone Health","OTHER",true,"This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.",null,[19],"Opioid Use Disorder",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},50,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Extended-Release Buprenorphine (XRB)","XRB (Sublocade) will be delivered as a pre-filled 2cc subcutaneous monthly injection, using a 300mg starting dose in most cases (100mg starting doses are available per the study team's clinical judgement). XRB consists of a depot injectable formulation in polymeric solution to the abdomen and releases buprenorphine over 28-days (4-weeks) by diffusion as the polymer biodegrades. Prior to an initial injection, the participant must be stable for several days or longer on sublingual buprenorphine (SLB) at doses of 8mg\u002Fday or higher. Participants will receive at least one XRB monthly injection prior to release, which investigators anticipate to usually be the 300mg dose. Some participants will be recruited earlier during the incarceration (or experience delayed release dates and then longer than anticipated incarcerations); XRB will be continued monthly from the time of induction to the day of release.",[34],"Transition to Extended-Release Buprenorphine (XRB)",[36],"Sublocade",{"type":30,"name":38,"description":39,"armGroupLabels":40},"Sublingual Buprenorphine (SLB)","Maintenance of existing SLB prescription (treatment as usual).",[41],"Sublingual Buprenorphine (SLB) Maintenance",[43],{"measure":44,"description":45,"timeFrame":46},"Percentage of participants released from jail with at least 7 days of buprenorphine in their system","The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.","Up to Month 6",[48],{"measure":49,"description":50,"timeFrame":51},"Percentage of participants continuing MOUD treatment in the community","Percentage of participants who continue to access medication for opioid use disorder (MOUD) once released from jail. This will be based on community clinic records indicating admission and retention.","Up to Month 9","MALE",false,{"inclusion":55,"exclusion":61,"raw_text":65},[56,57,58,59,60],"Incarcerated men able to provide written informed consent in English.\\*","Unsentenced.","Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.","Minimum anticipated jail stay is 4 days.","Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).",[62,63,64],"Sentenced.","Allergy, hypersensitivity or medical contraindication to either medication.","Chronic pain requiring opioid pain management or other contraindicated medications.","Inclusion Criteria:\n\n* Incarcerated men able to provide written informed consent in English.\\*\n* Unsentenced.\n* Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.\n* Minimum anticipated jail stay is 4 days.\n* Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).\n\nExclusion Criteria:\n\n* Sentenced.\n* Allergy, hypersensitivity or medical contraindication to either medication.\n* Chronic pain requiring opioid pain management or other contraindicated medications.",[67,68,69],"CHILD","ADULT","OLDER_ADULT",[71,84,94,108],{"facility":72,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":81},"Tufts University Health Sciences","Boston","Massachusetts","02111","United States",[78],{"name":79,"role":80},"Thomas Stopka, Ph.D.","PRINCIPAL_INVESTIGATOR",{"lat":82,"lon":83},42.35843,-71.05977,{"facility":85,"status":8,"city":86,"state":74,"zip":87,"country":76,"contacts":88,"geoPoint":91},"Baystate Health","Springfield","01199",[89],{"name":90,"role":80},"Peter Friedmann, MD",{"lat":92,"lon":93},42.10148,-72.58981,{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":76,"contacts":99,"geoPoint":105},"Middlesex County House of Corrections","New Brunswick","New Jersey","08902",[100,103],{"role":101,"phone":102},"CONTACT","732-297-3636",{"name":104,"role":80},"Kashif Siddiqi",{"lat":106,"lon":107},40.48622,-74.45182,{"facility":109,"status":8,"city":110,"state":110,"zip":111,"country":76,"geoPoint":112},"NYU Langone Health - 180 Madison Ave","New York","10016",{"lat":113,"lon":114},40.71427,-74.00597,[116],{"name":117,"role":101,"phone":118,"email":119},"David Farabee","310-963-0009","David.farabee@nyulagone.org",[121],{"name":122,"affiliation":13,"role":80},"David Farabee, PhD",[],[],{"nct_id":4,"conditions":126,"biomarkers":127},[19],[],{"nct_id":4,"found":15,"summary":129,"prompt_version":139},{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is a randomized controlled trial involving 200 participants. Participants will be randomly assigned to receive either XRB or continue with SLB.","completed","Study of Buprenorphine Treatment for Opioid Use Disorder in Jail","This study is looking at the best way to give buprenorphine to men with Opioid Use Disorder (OUD) who are in jail. It compares two forms of buprenorphine: Extended-Release Buprenorphine (XRB), given as a monthly injection, and Sublingual Buprenorphine (SLB), which is taken under the tongue. You could join if you are an incarcerated man, unsentenced, already taking SLB, and expect to be in jail for at least 4 days. The study wants to see if XRB helps more people leave jail with enough buprenorphine in their system, continue treatment after release, and reduce misuse of buprenorphine. The study is currently unclear on its recruitment status.","The primary goal is measured up to Month 6 after starting treatment.",106,"Not specified in the trial record.","Not stated in the trial record.",[31,38],"v2"]