[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526067":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":10,"responsibleParty":33,"collaborators":35,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":10,"overallStatus":77,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":10},{"fullName":5,"class":6},"PATH","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PWID who opt for LADB",null,"People with opioid dependence who opt to initiate LADB across a range of LMIC settings over a 48-week period",[13],"Drug: long-acting depot buprenorphine (LADB)",{"label":15,"type":10,"description":16,"interventionNames":10},"PWID who opt for standard of care","People with opioid dependence who refuse to initiate LADB and opt for standard of care",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","long-acting depot buprenorphine (LADB)","The intervention will measure patient-centered outcomes in people initiating LADB among a cohort of opioid-dependent PWID across sites in the seven project LMIC. Study participants will be enrolled from selected clinics that deliver routine opioid agonist maintenance treatment to PWID. The intervention will 1) Compare characteristics at baseline of those service clients who do and do not initiate LADB in relation to demographic characteristics, history of drug use, and outcomes; 2) Measure side effects and adverse events among those initiating LADB; and 3) Where appropriate, assess changes in outcomes between time of LADB initiation and 48 week follow-up, including HCV and HIV testing and treatment, quality of life, employment opportunities, and service preferences.",[9],[24],{"name":25,"affiliation":5,"role":26},"Kimberly Green","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Kimberly Green, MA, PhD","CONTACT","+1(202)-515-0626","kgreen@path.org",{"type":34,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[36,38,40,42,44,46,49,51,53,55,57,59],{"name":37,"class":6},"UNITAID",{"name":39,"class":6},"World Health Organization",{"name":41,"class":6},"Médecins du Monde",{"name":43,"class":6},"Frontline AIDS",{"name":45,"class":6},"London School of Hygiene and Tropical Medicine",{"name":47,"class":48},"International Network of People who Use Drugs","UNKNOWN",{"name":50,"class":6},"Monash University",{"name":52,"class":6},"Population Services International",{"name":54,"class":6},"Burnet Institute",{"name":56,"class":6},"University of Bristol",{"name":58,"class":6},"Alliance for the Public's Health",{"name":60,"class":48},"Coact Technical Support Limited","100526067","assessing-the-acceptability-feasibility-effectiveness-and-cost-effectiveness-of-ladb-100526067",false,"NCT06129916","Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB","Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of Long-acting Depot Buprenorphine (LADB) for the Treatment of Opioid Dependence in Low- and Middle-income Countries (LMIC): a Multicentre International Study","Inclusion Criteria:\n\n* Are 18 years old or older.\n* Are verified (by certified clinician) opioid dependents according to the International Classification of Diseases 11th Revision.\n* Are not pregnant (verified by screening).\n* Are eligible to receive OAMT at a participating site.\n* Consent to attend the clinic and adhere to clinical protocols\n* Have the capacity to consent to participating in research.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Have a history or presence of an allergic or adverse response (including rash or anaphylaxis) to BUP or the Atrigel® delivery system (a registered trademark of Tolmar Therapeutics Inc.) if Sublocade is chosen.\n* Have any contraindication to BUP or methadone.\n* Show signs of clinically significant medical conditions which would compromise compliance with the protocol and\u002For client safety in line with clinical guidelines for the administration of injectable BUP for OAMT.\n* Are currently taking oral or depot naltrexone therapy or are enrolled in any form of naltrexone therapy within 30 or 90 days prior to study screening, respectively.\n* Are in thepost partum period (defined as 6 weeks) or confirmed as pregnant.\n* Have an inability or unwillingness to provide informed consent or abide by the requirements of the study.","ALL","18 Years",{"count":71,"type":72},760,"ESTIMATED","OBSERVATIONAL","The goal of the proposed study is to generate evidence on the acceptability, feasibility, effectiveness, and cost-effectiveness of introducing long-acting depot buprenorphine (LADB) as an additional option for the treatment of opioid dependence in low- and middle-income countries (LMIC) among people who inject drugs (PWID) with opioid dependence. The study results will be used to inform global and local policies and guidelines to introduce LADB as a treatment option and to advocate for access to a sustainable supply of LADB in LMIC.",[76],"Opioid Dependence","NOT_YET_RECRUITING","2025-10-01",{"date":80,"type":81},"2025-10-07","ACTUAL",{"date":83,"type":72},"2025-11-01",{"date":85,"type":72},"2027-06-30",{"name":5,"class":6}]