[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04811014":3,"trial-entities:NCT04811014":133,"trial-summary:NCT04811014":137},{"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":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":71,"secondary_outcomes":79,"sex":84,"minimum_age":85,"maximum_age":86,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":104,"locations":106,"central_contacts":122,"overall_officials":128,"references":131,"see_also_links":132},"NCT04811014","HSC-MS-20-1376","Young Houston Emergency Opioid Engagement System","Houston Emergency Engagement System for Youths and Adolescents","RECRUITING","2030-08-31","2025-09","2025-10-01","2021-04-19","The University of Texas Health Science Center, Houston","OTHER",true,"The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston.","The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study recruits participants through three avenues: assertive community outreach with a peer coach and paramedic following and opioid overdose, community referrals, and emergency department referrals. The study explores the effect of the combination of assertive outreach, same-day induction into medication for opioid use disorder, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention in outpatient treatment. Secondary outcomes include quality of life assessment as well as subsequent relapses and overdoses. The hypothesis is that patients with earlier induction into MOUD treatment who receive routine follow-up, are more likely to engage and remain in treatment long-term.",[19,20,21,22,23],"Opioid-use Disorder","Opioid Dependence","Opioid Overdose","Opioid Use","Substance Use Disorders",[],"INTERVENTIONAL","TREATMENT",[28],"PHASE4",{"count":30,"type":31},250,"ESTIMATED",[33,41,48,55,61,65],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Buprenorphine, Naloxone Drug Combination","8mg of buprenorphine\u002F2mg of naloxone to initiate MOUD treatment and bridge, if necessary, until referral to MOUD clinic can be made for ongoing treatment",[38],"MOUD induction and behavioral interventions among opioid-dependent youths",[40],"Suboxone",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"BEHAVIORAL","Individual Counseling","One-on-one counseling with a licensed chemical dependency counselor",[38],[47],"Therapy",{"type":42,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Peer Recovery Support Services","24\u002F7 support from our team of certified peer recovery support specialists to assist with emotional support and case management",[38],[53,54],"Peer Coaching","Recovery Coaching",{"type":42,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Support Group","Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups",[38],[60],"Group Therapy",{"type":42,"name":62,"description":63,"armGroupLabels":64},"Referral to Medication Management","Study staff will refer patients to long-term MOUD providers in the community",[38],{"type":42,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Assertive Outreach","The investigators will conduct weekly outreach to youths who experienced an opioid overdose and attempt to initiate treatment. Outreach is completed by a paramedic and peer coach.",[38],[70],"Community Outreach",[72,76],{"measure":73,"description":74,"timeFrame":75},"Patient retention in treatment","Percentage of enrolled youth in treatment over time","30 days after enrollment",{"measure":77,"description":78,"timeFrame":75},"Patient abstinence from opioids","Days without substance use",[80],{"measure":81,"description":82,"timeFrame":83},"Frequency of opioid emergencies among adolescents in Houston, Texas","Prevalence of opioid overdoses among youth","Through study completion, an average of 3 years","ALL","13 Years","17 Years",false,{"inclusion":89,"exclusion":96,"raw_text":103},[90,91,92,93,94,95],"In otherwise good health based on physician assessment and medical history","Drug screen positive for opioids","Patients express a willingness to stop opioid use","Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence","Patients must be able to speak English","Be agreeable to and capable of signing the informed consent and assent (parent or guardian must consent, minor must assent)",[97,98,99,100,101,102],"Non-English-speaking patients","Have a known sensitivity to buprenorphine or naloxone","Be physiologically dependent on alcohol, benzodiazepines, or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary.","Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease)","Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk","Be a nursing or pregnant female","Inclusion Criteria:\n\n* In otherwise good health based on physician assessment and medical history\n* Drug screen positive for opioids\n* Patients express a willingness to stop opioid use\n* Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence\n* Patients must be able to speak English\n* Be agreeable to and capable of signing the informed consent and assent (parent or guardian must consent, minor must assent)\n\nExclusion Criteria:\n\n* Non-English-speaking patients\n* Have a known sensitivity to buprenorphine or naloxone\n* Be physiologically dependent on alcohol, benzodiazepines, or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary.\n* Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease)\n* Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk\n* Be a nursing or pregnant female",[105],"CHILD",[107],{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":119},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",[114],{"name":115,"role":116,"phone":117,"email":118},"James R Langabeer, PhD","CONTACT","713-500-3925","james.r.langabeer@uth.tmc.edu",{"lat":120,"lon":121},29.76328,-95.36327,[123,124],{"name":115,"role":116,"phone":117,"email":118},{"name":125,"role":116,"phone":126,"email":127},"Meredith M O'Neal, MA","713-500-3624","meredith.m.oneal@uth.tmc.edu",[129],{"name":115,"affiliation":13,"role":130},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":134,"biomarkers":136},[135],"Opioid Use Disorder",[],{"nct_id":4,"found":15,"summary":138,"prompt_version":148},{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This is an interventional study, meaning participants will receive specific treatments. It is a non-randomized cohort study based at the University of Texas Health Science Center of Houston, and plans to enroll 250 participants.","completed","Young HEROES Opioid Use Disorder Study","The Young Houston Emergency Opioid Engagement System (Young HEROES) is a research program for young people aged 13 to 17 who are struggling with opioid use disorder. This study aims to help you stop using opioids and stay in treatment. You would receive a combination of buprenorphine\u002Fnaloxone (a medication to treat opioid use disorder), individual counseling, support from peer recovery specialists, and referrals to support groups and long-term treatment. To join, you must be in good health, test positive for opioids, want to stop using opioids, meet specific diagnostic criteria, and be able to speak English. The study will look at how well participants stay in treatment and remain abstinent from opioids 30 days after starting the program. The current status of this study is unclear, and it plans to enroll 250 participants.","The primary outcomes of patient retention and abstinence from opioids are measured 30 days after enrollment.",133,"You would receive buprenorphine\u002Fnaloxone medication, individual counseling, peer recovery support services, and referrals to support groups and long-term medication management. The primary outcomes are measured 30 days after enrollment.","Not stated in the trial record.",[43,56],"v2"]