- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327061
Social Network Overdose Prevention and Education Intervention
April 12, 2024 updated by: Johns Hopkins Bloomberg School of Public Health
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
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carl Latkin, PhD
- Phone Number: (410)955-3972
- Email: carl.latkin@jhu.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins Bloomberg School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- self-reported illicit opioid use at least 2 times in the past two weeks;
- age 18 and older;
- living in the Baltimore metropolitan region;
- willing to engage in peer education; and
- having and willing to recruit at least one non-using network member.
Exclusion Criteria:
Participants without the cognitive ability to provide informed consent and have the physical ability to participate in in-person intervention sessions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Peer education and network support
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.
|
Participants are taught overdose prevention methods with network members.
|
Active Comparator: comparison: Standard of care of health education
In one session, participants will receive the standard of care for overdose prevention.
|
Participants will receive the standard of care for overdose prevention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of drug overdoses
Time Frame: 3-months
|
Number of drug overdoses in prior three months
|
3-months
|
Participant drug use
Time Frame: 3-months
|
Proportion of times participants tested positive for drugs of fentanyl and xylazine using test strips in the prior 3 months.
|
3-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Network member contacts
Time Frame: 3-months
|
Number of network members talked to about overdose prevention in prior 3 months
|
3-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Carl Latkin, PhD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
March 15, 2024
First Submitted That Met QC Criteria
March 15, 2024
First Posted (Actual)
March 25, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA058659 (U.S. NIH Grant/Contract)
- IRB00026607 (Other Identifier: JHSPH IRB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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