[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07421102":3,"trial-entities:NCT07421102":103,"trial-summary:NCT07421102":106},{"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":25,"primary_purpose":14,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":67,"locations":70,"central_contacts":98,"overall_officials":99,"references":101,"see_also_links":102},"NCT07421102","Pro00146867","Pilot of Mailing Buprenorphine","A Pragmatic Remote Approach to Improve Transitions of Care and Retention in Opioid Use Disorder Treatment","RECRUITING","2027-03","2026-04","2026-07-30","2026-04-08","Medical University of South Carolina","OTHER",true,"This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of mailing buprenorphine to individuals with opioid use disorder (OUD) following medical hospitalization. The intervention aims to improve retention in treatment by overcoming barriers such as transportation and pharmacy access.","This single-center, hybrid type 3 pilot study will enroll 20 medically hospitalized patients with OUD who are initiated on buprenorphine during their inpatient stay. Participants will be discharged with a supply of buprenorphine and enrolled in the MOUD Direct Delivery (MOUDDD) Program, which mails monthly refills directly to their homes. The study will evaluate the feasibility (successful delivery), acceptability (patient-reported measures), and preliminary effectiveness (treatment retention at 1, 3, and 6 months) of mailing buprenorphine. Secondary outcomes include quality of life, adherence, overdose, and healthcare utilization. The intervention leverages existing mail-order pharmacy protocols and aims to inform scalable strategies for improving transitions of care and retention in OUD treatment.",[19],"Opioid Use Disorder",[21,22,23,24],"mailing buprenorphine","transitions of care","opioid use disorder","barriers to buprenorphine","INTERVENTIONAL",[27],"EARLY_PHASE1",{"count":29,"type":30},20,"ESTIMATED",[32],{"type":14,"name":33,"description":34,"armGroupLabels":35},"strategy of mailing buprenorphine","This study examines the feasibility and preliminary effectiveness of mailing buprenorphine to overcome barriers such as transportation to obtaining buprenorphine from a pharmacy.",[36],"Mailed Medications",[38,42,46],{"measure":39,"description":40,"timeFrame":41},"Feasibility (successful receipt)","Successful delivery and receipt of medication defined by self-report and phone\u002Ftext\u002Fvideo confirmation to receive code","From enrollment to the end of the study at 6 months",{"measure":43,"description":44,"timeFrame":45},"Successful receipt","Feasibility is defined by the successful receipt of the buprenorphine prescriptions in the mail by the intended participants. Successful receipt defined by self-report and phone\u002Ftext\u002Fvideo confirmation from participant. Delivery failure is defined as delay in receipt of medication by \\>48 hours by the mail delivery service.","From enrollment to the end of study at 6 months.",{"measure":47,"description":48,"timeFrame":49},"Retention in treatment","Preliminary effectiveness of mailing buprenorphine will be measured by retention in treatment. This is defined by the proportion of participants retained in buprenorphine treatment at 1,3, and 6 months after discharge.","time of study enrollment to end of study at 6 months",[],"ALL","18 Years",null,false,{"inclusion":56,"exclusion":62,"raw_text":66},[57,58,59,60,61],"Age ≥ 18","English-speaking","Diagnosed with OUD and initiated on buprenorphine during hospitalization","Discharging to a South Carolina address with a stable mailbox","Access to phone or computer",[63,64,65],"Active psychosis or suicidal ideation","Severe medical or neurocognitive impairment","Pending incarceration","Inclusion Criteria:\n\n* Age ≥ 18\n* English-speaking\n* Diagnosed with OUD and initiated on buprenorphine during hospitalization\n* Discharging to a South Carolina address with a stable mailbox\n* Access to phone or computer\n\nExclusion Criteria:\n\n* Active psychosis or suicidal ideation\n* Severe medical or neurocognitive impairment\n* Pending incarceration",[68,69],"ADULT","OLDER_ADULT",[71,88],{"facility":13,"status":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":85},"NOT_YET_RECRUITING","Charleston","South Carolina","29425","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Allison Smith, MD","CONTACT","843-792-2100","smithall@musc.edu",{"name":79,"role":84},"PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},32.77632,-79.93275,{"facility":13,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":89,"geoPoint":97},[90,93,96],{"name":91,"role":80,"phone":92,"email":82},"Primary Investigator, MD","843-792-0686",{"name":94,"role":80,"email":95},"Research Coordinator, BS","schneidh@musc.edu",{"name":79,"role":84},{"lat":86,"lon":87},[],[100],{"name":79,"affiliation":13,"role":84},[],[],{"nct_id":4,"conditions":104,"biomarkers":105},[19],[],{"nct_id":4,"found":15,"summary":107,"prompt_version":117},{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is a single-center pilot study with 20 participants. It is an interventional study, meaning participants will receive a specific intervention.","completed","Pilot Study: Mailing Buprenorphine for Opioid Use Disorder","This pilot study is looking at a new way to help people with opioid use disorder (OUD) stay in treatment. It's testing if mailing buprenorphine (a medication used to treat OUD) directly to your home can help overcome problems like not having transportation or difficulty getting to a pharmacy. The study aims to enroll 20 English-speaking adults, aged 18 or older, who have OUD and are starting buprenorphine while in the hospital. You must be discharging to a South Carolina address with a stable mailbox and have access to a phone or computer. The main goals are to see if mailing buprenorphine is practical (successful delivery) and if it helps people stay in treatment for up to 6 months. The study's status is currently unclear.","Participants will be followed from enrollment to the end of the study at 6 months to assess successful receipt and retention in treatment.",125,"Participants will be enrolled in a program that mails monthly buprenorphine refills directly to their homes for up to 6 months.","Not stated in the trial record.",[],"v2"]