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Social Network Intervention for Opioid Overdose

N/A

Waitlist Available

Led By Carl A. Latkin, PhD

Research Sponsored by Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will help to assess the feasibility and effectiveness of this peer mentor intervention in preventing and responding to overdoses.

Who is the study for?

This trial is for adults over 18 living in the Baltimore area who use opiates like heroin, fentanyl, or prescription drugs to get high at least twice in the past two weeks. They must see a friend they can invite to the study twice a week and not be part of another Lighthouse study.Check my eligibility

What is being tested?

The study tests a peer mentor program aimed at preventing opioid overdoses. Participants will have three sessions with trained staff; one includes bringing someone from their social network to learn about overdose prevention together.See study design

What are the potential side effects?

Since this intervention involves education rather than medication, there are no direct medical side effects. However, discussing sensitive topics may cause emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Network Enrollment

Secondary outcome measures

Drug treatment entry

Overdose Risk

Side effects data

From 2017 Phase 4 trial • 570 Patients • NCT02032433

13%

Gastrointestinal

10%

Psychiatric

10%

Nervous system disorders

Infections and infestations

Injury, poisoning and procedural complications

Injury poisoning and procedural complications

Musculoskeletal and connective tissue disorders

General Disorders and Administration Site Conditions

Investigations

Skin and subcutaneous tissue disorders

Respiratory, thoracic, and mediastinal disorders

Metabolism and nutrition

Eye disorders

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Reproductive system and breast disorders

General disorders and administration site conditions

100%

80%

60%

40%

20%

Study treatment Arm

Extended-Release Naltrexone

Buprenorphine-Naloxone

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peer EducationExperimental Treatment2 Interventions

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.

Group II: Standard of careActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Narcan Nasal Product

2019

N/A

~620

Peer Education

2019

N/A

~830