Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT05645016
Status:
SUSPENDED
Last Update Posted:
2025-09-05
First Post:
2022-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailoring Overdose Education for Black Churches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083682', 'term': 'Opiate Overdose'}], 'ancestors': [{'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The design is a two-arm cluster randomized trial with randomization at the level of the church (4 Churches), and analyses at the level of the individual participants (i.e., church members).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'whyStopped': 'The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Frequency of Naloxone Utilization/Overdose Intervention', 'timeFrame': 'Baseline and 6 Months after COEST training', 'description': 'All study participants will receive an overdose response kit containing two doses of intranasal naloxone. Participants are asked to notify study staff immediately if they utilize naloxone in an attempt to reverse an opioid overdose.'}], 'secondaryOutcomes': [{'measure': 'Opioid Overdose Knowledge Scale (OOKS)', 'timeFrame': 'Baseline and 6 Months after COEST training', 'description': 'The OOKS measures knowledge about risk factors for having an opioid overdose, signs of an opioid overdose, actions to be taken in an overdose situation, naloxone effects and administration, adverse effects and aftercare procedures. The scale also identifies misinformation. The OOKS is a 14-item scale (Score Range: 0-45).'}, {'measure': 'Brief Opioid Stigma Scale (BOOS)', 'timeFrame': 'Baseline and 6 Months after COEST training', 'description': 'The BOSS was developed to assess stereotype awareness ("aware"), stereotype agreement ("agree"), and self-esteem decrement ("harm") surrounding opioid dependence. The BOSS is a 12-item scale (Score Range: 12-60)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Overdose']}, 'descriptionModule': {'briefSummary': 'Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. For Overdose Education and Naloxone Distribution (OEND) to be efficacious in Black churches, tailoring may be needed. For this audience, standard OEND curricula may need to be adapted to their level of knowledge of substance use disorders (SUDs), and limited general mental health literacy, and specifically address stigma related to SUDs and medications for opioid use disorder (MOUD). Finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. The proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., COEST) to target Black communities of faith. In a pilot randomized controlled trial (RTC) of adapted COEST in a stepped-wedge design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Identify as one of the following group members of the Black church: Clergy; Individual with OUD and/or stimulant use disorder; Family member or friend of an individual with OUD; Formerly incarcerated.\n2. Age 18 and older.\n\nExclusion Criteria:\n\n1. Unable to provide informed consent.\n2. Less than 18 years old.\n3. Does not identify as belonging to one of the four stakeholder groups.'}, 'identificationModule': {'nctId': 'NCT05645016', 'briefTitle': 'Tailoring Overdose Education for Black Churches', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Church-Tailored Opioid Overdose Education and Naloxone Distribution to Target Overdose and Stigma Among African-American Communities', 'orgStudyIdInfo': {'id': '8208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapted Comprehensive Overdose Education and Skills Training (COEST)', 'interventionNames': ['Behavioral: COEST']}], 'interventions': [{'name': 'COEST', 'type': 'BEHAVIORAL', 'description': 'Adapted version of our COEST training, targeting Black church members.', 'armGroupLabels': ['Adapted Comprehensive Overdose Education and Skills Training (COEST)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Neurobiology', 'investigatorFullName': 'Jermaine D. Jones', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}