- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04212364
An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses
The purpose of this study is to pilot and implement a peer mentor intervention focused on overdose prevention and care.
The intervention consists of 3 sessions. During the first and second session, each participant will meet individually with a trained staff member. In the 3rd session, the participant will invite a social network member to attend the session, and these 2 participants will meet with a trained staff member.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific aims of the study are:
- Conduct a pilot of an HIV/HCV/overdose prevention and care intervention for people who use opiates.
- Evaluate the feasibility of collecting donated drug preparation containers (i.e., cookers) to assess the presence of fentanyl, HCV, and HIV.
- Conduct a randomized controlled trial to assess efficacy of the experimental Peer Mentor condition on (a) overdose prevention and care education to drug network members, (b) naloxone availability, and (c) drug treatment readiness and entry.
There are two types of participants: Index participants and network participants. Both type of participant will currently used opiates. Participants will take part in a baseline visit and up to 3 follow-up visits. Index participants will be randomized into the intervention or control arm of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carl A. Latkin, PhD
- Phone Number: 4109553972
- Email: carl.latkin@jhu.edu
Study Contact Backup
- Name: Melissa A Davey-Rothwell, PhD
- Phone Number: 410-502-5368
- Email: mdavey1@jhu.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Lighthouse Studies at Peer Point
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for Index participants:
- self-reported use of opiates including heroin, fentanyl, or prescription opiates to get high at least 2 times in the last two weeks;
- willing to invite a network member who uses drugs to the study;
- ages 18-years or older;
- living in the Baltimore metropolitan region, and
- not previously enrolled in the study or currently enrolled in another Lighthouse study.
Inclusion Criteria for network participants:
- self-reported use of illicit injecting or non-injecting opiates at least 2 times in the last two weeks;
- sees the Index participant 2 or more times in the past week;
- ages 18 years or older; and
- living in the Baltimore metropolitan region.
Exclusion Criteria:
- Index participants may not take part in the study as a Network participant.
- Network participants may not take part in the study as an Index participant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peer Education
|
In this intervention, people who use opiates will be trained to be peer educators.
Other Names:
All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.
|
Active Comparator: Standard of care
|
All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Network Enrollment
Time Frame: 6 months
|
The question will be: How many people in their social network did Index participants recruit to the study?
Participants provide a number of 0 or higher.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug treatment entry
Time Frame: 12 months
|
The question will be: In the past 12 months, did you enroll in a drug treatment program including a medically assisted treatment program?
The response options are yes and no.
|
12 months
|
Overdose Risk
Time Frame: 12 months
|
Change in risk will be measured by a score that includes frequency of naloxone availability when using opiates, testing drugs before injecting, and drug use alone.
Higher scores will indicate increased overdose risk.
Scores will be measured from 0-9
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carl A. Latkin, PhD, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01CE003021 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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