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OpenTrials
Completed

NCT Number: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lighthouse Studies at Peer Point

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer Education

Behavioral

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

Other names: Experimental arm

Narcan Nasal Product

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2019
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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