Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-26 @ 7:00 AM
Study NCT ID:
NCT06327061
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Network Overdose Prevention and Education Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062787', 'term': 'Drug Overdose'}], 'ancestors': [{'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Both groups receive overdose prevention training'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a standard two-group clinical trial, one group is the experimental, the other the control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-04-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of drug overdoses', 'timeFrame': '3-months', 'description': 'Number of drug overdoses in prior three months'}, {'measure': 'Participant drug use', 'timeFrame': '3-months', 'description': 'Proportion of times participants tested positive for drugs of fentanyl and xylazine using test strips in the prior 3 months.'}], 'secondaryOutcomes': [{'measure': 'Number of Network member contacts', 'timeFrame': '3-months', 'description': 'Number of network members talked to about overdose prevention in prior 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Overdose']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs).', 'detailedDescription': 'The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs). The investigators have utilized PEs for overdose prevention in interventions that have focused on training network members who use drugs to respond to an overdose. Yet, many overdoses are witnessed by people who do not use drugs. Additionally, many PWUO report using drugs at home and living with someone who does not use drugs, which highlights the importance of training non-using network members on overdose response. Based on pilot data, the investigators propose expanding an overdose peer education intervention to focus on non-using network members. The intervention seeks to prepare network members to respond to an overdose and normalize discussions about overdose prevention planning between index PWUO and non-using network members. The intervention condition consists of 3 individual sessions focused on overdose prevention and response. This condition is designed to train index study participants to be Peer Educators. In addition to the three sessions, the non-drug using network member will be offered one session. The control condition is only 1 session focused on overdose prevention and response. Both intervention and control participants will invite social network members to take part in data collection activities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-reported illicit opioid use at least 2 times in the past two weeks;\n* age 18 and older;\n* living in the Baltimore metropolitan region;\n* willing to engage in peer education; and\n* having and willing to recruit at least one non-using network member.\n\nExclusion Criteria:\n\nParticipants without the cognitive ability to provide informed consent and have the physical ability to participate in in-person intervention sessions.'}, 'identificationModule': {'nctId': 'NCT06327061', 'briefTitle': 'Social Network Overdose Prevention and Education Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'A Social Diffusion Fatal Overdose Prevention Intervention: Assessing the Effectiveness of People Who Use Opioids as Peer Educators in Training Using & Non-using Networks on Overdose & Stigma Reduction', 'orgStudyIdInfo': {'id': 'R01DA058659', 'link': 'https://reporter.nih.gov/quickSearch/R01DA058659', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'IRB00026607', 'type': 'OTHER', 'domain': 'JHSPH IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Peer education and network support', 'description': 'During sessions 1 and 2, participants will be taught information and skills pertaining to overdose prevention and response. During the 3rd session, participants will trained to talk to their non drug using network members in overdose prevention and response.', 'interventionNames': ['Behavioral: Network overdose prevention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comparison: Standard of care of health education', 'description': 'In one session, participants will receive the standard of care for overdose prevention.', 'interventionNames': ['Behavioral: Standard of care health education']}], 'interventions': [{'name': 'Network overdose prevention', 'type': 'BEHAVIORAL', 'description': 'Participants are taught overdose prevention methods with network members.', 'armGroupLabels': ['Experimental: Peer education and network support']}, {'name': 'Standard of care health education', 'type': 'BEHAVIORAL', 'description': 'Participants will receive the standard of care for overdose prevention.', 'armGroupLabels': ['comparison: Standard of care of health education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carl Latkin, PhD', 'role': 'CONTACT', 'email': 'clatkin@jhsph.edu', 'phone': '410-955-3972'}, {'name': 'Carl Latkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins Bloomberg School of Public Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Carl Latkin, PhD', 'role': 'CONTACT', 'email': 'carl.latkin@jhu.edu', 'phone': '(410)955-3972'}], 'overallOfficials': [{'name': 'Carl Latkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}