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

Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212364
• Other study ID #: 1R01CE003021
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The specific aims of the study are: 1. Conduct a pilot of an HIV/HCV/overdose prevention and care intervention for people who use opiates. 2. Evaluate the feasibility of collecting donated drug preparation containers (i.e., cookers) to assess the presence of fentanyl, HCV, and HIV. 3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: December 31, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Overdose

Intervention

Behavioral:
• Peer Education
In this intervention, people who use opiates will be trained to be peer educators.

Drug:
• Narcan Nasal Product
All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.

Locations

Country	Name	City	State
United States	Lighthouse Studies at Peer Point	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Drug treatment entry	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
Secondary	Overdose Risk	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