NCT02669901

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

Completed NA Results posted Last updated 12 August 2024

What this trial tests

NA trial testing Naloxone Auto-Injector in Opiate Antagonist Overdose in 395 participants. Completed in 20 August 2020.

Timeline

4 April 2016

Primary endpoint
16 May 2017

20 August 2020

Quick facts

Lead sponsor	University of New Mexico
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	395
Start date	4 April 2016
Primary completion	16 May 2017
Estimated completion	20 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Naloxone Auto-Injector

Conditions studied

• Opiate Antagonist Overdose — all drugs for Opiate Antagonist Overdose →
• Opioid-Related Disorders — all drugs for Opioid-Related Disorders →

Sponsor

University of New Mexico

Who can join

18 and older, any sex, with Opiate Antagonist Overdose or Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

To Measure the Association of Take-home Naloxone With Overdose Reversals Performed by Patients With Opioid Use Disorder Enrolled in an Opioid Treatment Program Primary · 1 year after enrollment

The study participants received 2 naloxone kits at their initial visit. They were educated on how to recognize the signs and symptoms of an OD, the importance of calling 911, rescue breathing techniques, and staying with the person experiencing the OD until medical help has arrived. They were asked about their use of naloxone every 3 months, including the situation of the naloxone kits, dose, and to whom they used.

Group	Value	95% CI
Patients With Opioid Use Disorder	73
Patients With Opioid Use Disorder	263

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association of Take-Home Naloxone and Opioid Overdose Reversals Performed by Patients in an Opioid Treatment Program.
   Katzman JG, Takeda MY, Greenberg N, Moya Balasch M, et al · · 2020 · cited 38× · PMID 32101312 · DOI 10.1001/jamanetworkopen.2020.0117
2. An Innovative Model for Naloxone Use Within an OTP Setting: A Prospective Cohort Study.
   Katzman JG, Takeda MY, Bhatt SR, Moya Balasch M, et al · · 2018 · cited 13× · PMID 29227321 · DOI 10.1097/adm.0000000000000374