Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:34 PM
Study NCT ID:
NCT07485335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bundled Intervention - Phase 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000083682', 'term': 'Opiate Overdose'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'participant retention rate', 'timeFrame': '1 month and 3 months post hospital discharge', 'description': 'measure the total number of participants who complete 1- month and 3-month treatment in the study'}, {'measure': 'buprenorphine adherence rate', 'timeFrame': '1 month and 3 months post ED discharge', 'description': "checking prescription rate and patients' self report of their taking medication"}, {'measure': 'linkage rate to addiction treatment programs', 'timeFrame': '1 month and 3 months post hospital discharge', 'description': "patients' self report and reports from addiction treatment programs"}, {'measure': 'Frequency of Repeat Opioid Overdose', 'timeFrame': 'Monitored quarterly throughout the R33 study period beyond the 3-month intervention', 'description': 'Repeat opioid overdose events monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital'}, {'measure': 'Healthcare Utilization (Hospital Revisit Rates)', 'timeFrame': 'Monitored quarterly throughout the R33 study period beyond the 3-month intervention', 'description': 'Opioid overdose-related hospital revisits after the initial ED encounter, monitored via EMR documentation at UAB Hospital'}, {'measure': 'Adherence to Peer Support Specialist Contact', 'timeFrame': 'Throughout the 12-week intervention period post hospital discharge', 'description': 'Rate of participant adherence to the scheduled peer support specialist contact protocol, including daily contact in Week 1, every other day contact in Week 2, and weekly contact in Weeks 3-12 post-ED discharge, as recorded in peer activity logs documenting dates, times, and length of each telehealth contact'}, {'measure': 'Opioid Overdose Death', 'timeFrame': 'Monitored quarterly throughout the R33 study period beyond the 3-month intervention', 'description': 'Opioid overdose deaths monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital'}], 'secondaryOutcomes': [{'measure': 'changes in quality of Life', 'timeFrame': 'Baseline, 1-month and 3-month post hospital discharge', 'description': 'Participant quality of life will be assessed using validated self-report instruments measuring physical and psychosocial aspects of life specific to drug abuse populations'}, {'measure': 'Mental Health Status', 'timeFrame': 'Baseline, 1-month (25-35 days), and 3-month (85-95 days) post hospital discharge', 'description': 'Participant mental health status will be assessed using validated self-report instruments measuring severity of anxiety, depression, and perceived stress'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency department', 'post discharge', 'buprenorphine', 'peer support specialist', 'telehealth'], 'conditions': ['Opioid Use Disorder', 'Opioid Overdose']}, 'descriptionModule': {'briefSummary': 'Opioid overdose deaths have reached historically high records in the United States and are particularly concentrated among patients after emergency department (ED) discharge. Evidence-based treatment modules to reduce repeat opioid overdose and mortality are lacking in this patient population. A bundled intervention is proposed, including telehealth, peer support specialist, buprenorphine, and linkage for definitive care, that is designed to increase treatment uptake in this patient population post-ED discharge, reduce repeat opioid overdoses, and end overdose deaths.', 'detailedDescription': "This study is supported by the HEAL Initiative (https://heal.nih.gov). Opioid overdose deaths have reached historically high records in the U.S. and are particularly concentrated among patients after emergency department (ED) discharge. Medications for opioid use disorder (MOUDs), including buprenorphine, are the most effective treatments for opioid use disorder (OUD) as MOUD reduce opioid-related overdoses and deaths. Despite this, less than 30% patients with OUD are treated with MOUDs. Furthermore, adequate treatment with MOUD can be more difficult in certain patient population, i.e., patients with nonfatal opioid overdoses after ED discharge. This patient population also accounts for substantial health care utilization, frequent ED visits, and the largest at-risk group for repeat overdoses and even deaths. Many barriers, including patients' stigma on MOUDs, lack of appropriate monitoring and support, difficulty in navigating community-based treatment programs and being connected with buprenorphine clinics for continuity of care, have been identified as contributors to poor treatment uptake post-ED discharge. These barriers present a pressing need to develop novel treatment modules. Peer support models and telehealth have been successful in improving service provision and increasing treatment uptake in substance use disorders. However, it remains untested if a bundled intervention of telehealth, peers, buprenorphine, and linkage to definitive addiction programs can increase treatment uptake in this particular population. Thus, the purpose of this proposal is to test this bundled intervention specifically focusing on patients with OUD and nonfatal opioid overdoses post-ED discharge.\n\nIn the R33 phase, participants will be enrolled and randomized to either the intervention group (N=80) or the usual care group (UC, N=80). Patients will be enrolled from the same ED and same eligibility criteria as in the R61 phase will be applied. Randomization will be computer-generated using permuted blocks and will be stratified by age, sex at birth, ethnicity, comorbid diseases, and recruitment site (inpatient unit or emergency department) to ensure balanced allocation across groups. This study is open-label; participants and study staff will not be blinded to treatment assignment. In the intervention group, peers and physicians will provide the same intervention to patients as in the R61 phase, including peer support specialists meeting participants prior to ED discharge, scheduled telehealth contact throughout the 12-week period, and physician-led buprenorphine prescribing and management via telehealth. At the conclusion of the 12-week intervention, participants will receive a warm handoff from the peer support specialist to facilitate linkage to long-term community-based addiction treatment and recovery resources. Patients in the UC group will receive the usual care that has been established at the ED, including ED-initiated buprenorphine, and a list of community-based substance treatment programs and buprenorphine clinics at ED discharge. However, no further intervention will be provided in the UC group. Follow-up assessments will be completed at 1 and 3 months via survey links sent to participants' cell phones and/or emails through REDCap, with reminder messages sent twice daily for 5 days prior to each assessment. Primary outcomes will be increased treatment uptake and retention after ED discharge, and reduced opioid overdoses and ED revisits, compared to the UC group. If successful, this project will lay the groundwork for a multi-site trial to validate the treatment and to identify actual implementation and sustainability barriers and best practices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. discharged from the ED and inpatient settings at the UAB hospital\n2. 19 years or older (the age of majority in Alabama);\n3. diagnosis of OUD and experiencing opioid overdose in the last 12 months;\n4. prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;\n5. English speaking;\n6. not actively psychotic and suicidal, or cognitively impaired.\n7. Patients who are admitted to the hospital from the ED will be eligible for enrollment.\n\nExclusion Criteria:\n\n1. living in a restricted environment (e.g., prison or jail facility, etc.);\n2. currently enrolled in other clinical studies;\n3. anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months;\n4. known allergic reaction to buprenorphine;\n5. critically ill or injured;\n6. females with pregnancy (they are anticipated to request a higher level of care).\n7. living outside of Alabama'}, 'identificationModule': {'nctId': 'NCT07485335', 'acronym': 'B-CARE', 'briefTitle': 'A Bundled Intervention - Phase 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Implementation and Effectiveness Testing of a Bundled Post-Hospital Intervention for Non-fatal Opioid Overdoses', 'orgStudyIdInfo': {'id': 'DA062351'}, 'secondaryIdInfos': [{'id': 'NIH', 'type': 'OTHER_GRANT', 'domain': 'NIDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental (Bundled Intervention)', 'description': 'Participants will be enrolled and randomized (stratified) to the experimental (bundled intervention) group. Bundled intervention components include scheduled peer support contacts, buprenorphine treatment with addiction physicians using telehealth, and linkage to definitive addiction treatment programs, up to 3 months after ED/hospital discharge. Participants will complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.', 'interventionNames': ['Other: Bundled intervention (Experimental)', 'Drug: Buprenorphine (Experimental)', 'Behavioral: Scheduled Peer Support Specialist (Experimental)', 'Other: Telemedicine Buprenorphine Treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control (Usual Care)', 'description': "Participants randomized to the control group will receive the usual care established at UAB Hospital. Current usual care includes a thorough assessment, buprenorphine initiation as appropriate, peer referral, and a written list of buprenorphine clinics. Participants will also receive information about community-based substance use treatment programs; however, these services are at the participant's own discretion to navigate and attend after ED discharge. Participants will complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.", 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'Bundled intervention (Experimental)', 'type': 'OTHER', 'description': 'a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs.', 'armGroupLabels': ['Experimental (Bundled Intervention)']}, {'name': 'control group', 'type': 'OTHER', 'description': 'participants will not be intervened with this bundled treatment, but continue the usual care that has been established at UAB hospital', 'armGroupLabels': ['Control (Usual Care)']}, {'name': 'Buprenorphine (Experimental)', 'type': 'DRUG', 'description': 'Participants in the experimental arm will receive buprenorphine treatment for opioid use disorder, including buprenorphine/naloxone (sublingual film or tablet), buprenorphine (sublingual tablet), or buprenorphine extended-release, as determined by the study physician via telehealth. Medication will be provided for the duration of the 12-week intervention period. Participants without insurance or who are underinsured will be provided medication at no cost to ensure equitable access.', 'armGroupLabels': ['Experimental (Bundled Intervention)']}, {'name': 'Scheduled Peer Support Specialist (Experimental)', 'type': 'BEHAVIORAL', 'description': 'Participants in the experimental arm will be introduced to a peer support specialist prior to hospital discharge. Peer support specialists, who have lived experience with substance use disorder and recovery, will provide ongoing support throughout the 12-week intervention period. Specialists will assist participants in navigating and attending community-based addiction treatment resources, including buprenorphine clinics and substance use treatment programs. At the conclusion of the 12-week intervention, participants will receive a warm handoff from the peer support specialist to facilitate linkage to long-term community-based addiction treatment and recovery resources.', 'armGroupLabels': ['Experimental (Bundled Intervention)']}, {'name': 'Telemedicine Buprenorphine Treatment', 'type': 'OTHER', 'description': "Participants in the experimental arm will receive telehealth-enabled services throughout the 12-week intervention period. Addiction physicians will conduct virtual visits to evaluate, prescribe, and manage buprenorphine for opioid use disorder. Peer support specialists will maintain scheduled contact with participants via telehealth to provide ongoing support and monitor participant progress. Follow-up assessments at 1 and 3 months will be completed remotely via survey links sent to participants' cell phones and/or emails through REDCap, with reminder messages sent twice daily for 5 days prior to each assessment.", 'armGroupLabels': ['Experimental (Bundled Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'contacts': [{'name': 'Li Li, MD;PhD', 'role': 'CONTACT', 'email': 'liyli@uabmc.edu', 'phone': '2059346269'}, {'name': 'Li Li, MD;PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UAB', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Li Li, MD;PhD', 'role': 'CONTACT', 'email': 'liyli@uabmc.edu', 'phone': '2059346269'}], 'overallOfficials': [{'name': 'Li Li, MD;PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'we have not started the enrollment yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Li Li', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}