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

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669901
• Other study ID #: 15-616
• Status: Completed
• Phase: N/A
• Start date: April 4, 2016
• Est. completion date: August 20, 2020

Study information

• Verified date: September 2022
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: August 20, 2020
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Disease
• Drug Overdose
• Opiate Antagonist Overdose
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Naloxone Auto-Injector
Naloxone auto-injector is the only product 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.

Locations

Country	Name	City	State
United States	UNM Hospitals - Alcohol and Substance Abuse Program	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Kaleo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of fatal over dose deaths by use of naloxone auto-injector co-prescribing from the University of New Mexico Addiction and Substance Abuse Program (UNM ASAP)	Patients on chronic opioid therapy will be co-prescribed a naloxone-autoinjector rescue kit to decrease the accidental overdose rate associated with these medications.	2 years
Primary	number of near fatal overdoses prevented by use of naloxone auto-injector co-prescribing from the University of New Mexico Addiction and Substance Abuse Program (UNM ASAP)	Patients on chronic opioid therapy will be co-prescribed a naloxone-autoinjector rescue kit to decrease the accidental overdose rate associated with these medications.	2 years