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Overdose Risk Management and Naloxone

NCT03933345 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2019-05-01

No results posted yet for this study

Summary

A growing body of research underscores the life- and cost-saving advantages of equipping people who use opioids with naloxone, but very little is known about: 1) barriers to naloxone awareness and access, and 2) the potential psychosocial and behavioral impacts of being "protected" by naloxone while engaging in overdose risk behaviors, of using naloxone on someone else, and of surviving an overdose in which naloxone is used. This research will provide insight into both of these domains to yield a richly contextualized understanding of the processes and mechanisms underlying changes in overdose risk behaviors related to naloxone access and use and will illuminate the disparities that may limit access to naloxone for some or result in compensatory behavior following naloxone exposure for others. Findings from this study will provide an empirical basis to strengthen and refine existing overdose prevention efforts and to design tailored interventions to engage opioid users who have recently survived or reversed an overdose.

Conditions

  • Opioid Use

Interventions

OTHER

Study provides naloxone to participants who wish to have it. Not required to accept naloxone and no control.

At enrollment, participants will complete a detailed survey instrument establishing histories of substance use, naloxone exposure, and other potential barriers to the uptake of naloxone training. Because extant research establishes a clear public health and ethical imperative to provide PWUIO with naloxone, we will also offer all participants training to become naloxone-equipped OD responders at enrollment. We will follow the sample for two years using a mixed-methods approach involving text-message-based exposure tracking, monthly surveys using a state-of-the-art online data collection portal, and a qualitative subsample to ensure that naloxone exposures and changes in OD risk behavior are carefully tracked and contextualized by ethnographic data about the psychosocial and sociocultural mechanisms underlying participant experiences.

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • Brandeis University

    collaborator OTHER

  • Drexel University

    collaborator OTHER

  • New York University

    collaborator OTHER

  • National Development and Research Institutes, Inc.

    lead OTHER

Principal Investigators

  • Andrew Rosenblum · National Development & Research Institutes (NDRI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2022-08-01
Completion
2023-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933345 on ClinicalTrials.gov