Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 2:51 PM
Study NCT ID:
NCT07421102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot of Mailing Buprenorphine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pilot study designed to study the strategy of mailing buprenorphine and examine feasibility and preliminary effects of the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility (successful receipt)', 'timeFrame': 'From enrollment to the end of the study at 6 months', 'description': 'Successful delivery and receipt of medication defined by self-report and phone/text/video confirmation to receive code'}, {'measure': 'Successful receipt', 'timeFrame': 'From enrollment to the end of study at 6 months.', 'description': '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/text/video confirmation from participant. Delivery failure is defined as delay in receipt of medication by \\>48 hours by the mail delivery service.'}, {'measure': 'Retention in treatment', 'timeFrame': 'time of study enrollment to end of study at 6 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mailing buprenorphine', 'transitions of care', 'opioid use disorder', 'barriers to buprenorphine'], 'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07421102', 'briefTitle': 'Pilot of Mailing Buprenorphine', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'A Pragmatic Remote Approach to Improve Transitions of Care and Retention in Opioid Use Disorder Treatment', 'orgStudyIdInfo': {'id': 'Pro00146867'}, 'secondaryIdInfos': [{'id': 'K12DA031794', 'link': 'https://reporter.nih.gov/quickSearch/K12DA031794', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mailed Medications', 'description': 'There is no comparison arm. This pilot study evaluates the feasibility of mailing medications to patients.', 'interventionNames': ['Other: strategy of mailing buprenorphine']}], 'interventions': [{'name': 'strategy of mailing buprenorphine', 'type': 'OTHER', 'description': 'This study examines the feasibility and preliminary effectiveness of mailing buprenorphine to overcome barriers such as transportation to obtaining buprenorphine from a pharmacy.', 'armGroupLabels': ['Mailed Medications']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'contacts': [{'name': 'Allison Smith, MD', 'role': 'CONTACT', 'email': 'smithall@musc.edu', 'phone': '843-792-2100'}, {'name': 'Allison Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Allison Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor-Faculty', 'investigatorFullName': 'Allison Smith', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}