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Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder

NCT02669901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2024-08-12

Study results available
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Summary

The purpose of this pilot-study is to to distribute naloxone auto-injector in a "Universal Precaution" manner to patients with opioid substance use disorder. The objectives are to decrease the number of fatal and nonfatal overdose deaths, to examine and understand the risk factors for serious opioid toxicity and overdose, and to evaluate the unintentional opioid overdose risk utilizing an evidence-based screening questionnaire.

Conditions

  • Opiate Antagonist Overdose
  • Opioid-Related Disorders

Interventions

BEHAVIORAL

Naloxone Auto-Injector

Naloxone auto-injector is FDA approved and labeled for use by family members or caregivers for emergency therapy and rescue wherever opioids are present. Bystanders of patient are able to provide naloxone when drug overdose occurs.

Sponsors & Collaborators

  • Kaleo Inc.

    collaborator OTHER

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Joanna Katzman, MD · University of New Mexico School of Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-04
Primary Completion
2017-05-16
Completion
2020-08-20

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 NCT02669901 on ClinicalTrials.gov