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

NCT02669901 | Completed Results DMC

• 1 other identifier: 15-616
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Opioid-Related Disorders; Naloxone; Harm Reduction; Drug Overdose Deaths; Opioid Misuse; Naloxone Coprescribing; Universal Precautions; Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• To Measure the Association of Take-home Naloxone With Overdose Reversals Performed by Patients With Opioid Use Disorder Enrolled in an Opioid Treatment Program

  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.

  1 year after enrollment

Study Arms (1)

Patients with opioid use disorder

OTHER

All participants received Naloxone autoinjector as a preventative tool for accidental opioid overdose

Behavioral: Naloxone Auto-Injector

Interventions

Naloxone Auto-Injector BEHAVIORAL

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.

Patients with opioid use disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients treated with methadone, naltrexone or buprenorphine as medication assisted treatment at the UNM Addiction and Substance Abuse Program (UNM ASAP) aged 18 or older

You may not qualify if:

• Subjects who are allergic to naloxone and its inactive ingredients. Inactive ingredients include buffering agents.
• Subjects younger than 18.
• Subjects not being treated at UNM ASAP.

Sponsors & Collaborators

• University of New Mexico: lead
• Kaleo Inc.: collaborator

Study Sites (1)

UNM Hospitals - Alcohol and Substance Abuse Program

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (1)

• Katzman JG, Takeda MY, Greenberg N, Moya Balasch M, Alchbli A, Katzman WG, Salvador JG, Bhatt SR. Association of Take-Home Naloxone and Opioid Overdose Reversals Performed by Patients in an Opioid Treatment Program. JAMA Netw Open. 2020 Feb 5;3(2):e200117. doi: 10.1001/jamanetworkopen.2020.0117.

  PMID: 32101312 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Harm Reduction

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dr. Joanna Katzman, Principal Investigator
• Organization: Univesity of New Mexico School of Medicine

JKatzman@salud.unm.edu

(505) 272-2321

Study Officials

• Joanna Katzman, MD

  University of New Mexico School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Joanna Katzman

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: February 1, 2016
• Study Start: April 4, 2016
• Primary Completion: May 16, 2017
• Study Completion: August 20, 2020
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)