NCT06327061

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Jun 2024Apr 2029

First Submitted

Initial submission to the registry

March 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

March 15, 2024

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of drug overdoses

    Number of drug overdoses in prior three months

    3-months

  • Participant drug use

    Proportion of times participants tested positive for drugs of fentanyl and xylazine using test strips in the prior 3 months.

    3-months

Secondary Outcomes (1)

  • Number of Network member contacts

    3-months

Study Arms (2)

Experimental: Peer education and network support

EXPERIMENTAL

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.

Behavioral: Network overdose prevention

comparison: Standard of care of health education

ACTIVE COMPARATOR

In one session, participants will receive the standard of care for overdose prevention.

Behavioral: Standard of care health education

Interventions

Participants will receive the standard of care for overdose prevention.

comparison: Standard of care of health education

Participants are taught overdose prevention methods with network members.

Experimental: Peer education and network support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants without the cognitive ability to provide informed consent and have the physical ability to participate in in-person intervention sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Carl Latkin, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Latkin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Both groups receive overdose prevention training
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: a standard two-group clinical trial, one group is the experimental, the other the control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 25, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations