CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 395 enrolled
Drug / intervention
Naloxone Auto-Injectorbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02669901
NCT02669901N/ACompleted

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

University of New Mexico·interventional·Posted Feb 1, 2016·Updated Aug 12, 2024

In Brief

A clinical study evaluating Naloxone Auto-Injector for Opiate Antagonist Overdose and Opioid-Related Disorders. Completed, enrolled 395 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsKaleo Inc.

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 1, 2016
Enrollment StartApr 4, 2016
Primary CompletionMay 16, 2017
Study CompletionAug 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.4 years ago

Interventions

Naloxone Auto-Injectorbehavioral

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.