An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses

NCT04212364 | Completed DMC

• 1 other identifier: 1R01CE003021
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overdose

Keywords

peer education; social networks

Outcome Measures

Primary Outcomes (1)

• Network Enrollment

  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 Outcomes (2)

• Drug treatment entry

  12 months

• Overdose Risk

  12 months

Study Arms (2)

Peer Education

EXPERIMENTAL

* During Session 1, participants will be trained in Peer Education and how to use Nasal Narcan. They will be given two Nasal Narcan kit that includes 2 doses. One kit if for their use and one kit is to give someone in their social network after they have trained them in how to use it. * A week after Session 1, participants will be scheduled for Session 2. * During session 1 and 2 participants, Index participants will be taught information and skills pertaining to overdose prevention and response and how to train network members in overdose prevention and response. * At the 2nd session, index participants will be given 1 coupon to give to 1 member from their social network to attend Session 3. * Session 3 will be a dyad session where Index participants will use their peer mentors' skills to train their network member in overdose prevention and response. * Index participants will also be invited to up to 3 Booster Session (monthly) after they complete Sessions 1-3.

Behavioral: Peer Education; Drug: Narcan Nasal Product

Standard of care

ACTIVE COMPARATOR

* Participants randomized to this condition will participate in one 1-hour session. This session will be an individual session where the participant will meet with a trained staff member in a private room at the Lighthouse. * This session will be standard overdose prevention and response information. Participants will also be trained in Narcan administration. Participants will be given 1 nasal Narcan kit. * At the end of this session, participants will be asked to refer a network member to the study for survey visits

Drug: Narcan Nasal Product

Interventions

Peer Education BEHAVIORAL

In this intervention, people who use opiates will be trained to be peer educators.

Also known as: Experimental arm

Peer Education

Narcan Nasal Product DRUG

All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.

Peer Education; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Lighthouse Studies at Peer Point

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Carl A. Latkin, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Index participants will be randomized into 1 of two study arms.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: December 27, 2019
• Study Start: March 15, 2019
• Primary Completion: December 29, 2023
• Study Completion: December 31, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

US (1)