Back to resultsNaloxone Auto-injector as a Universal Precaution for Patients With Opioid Substance Use Disorder
Primary Purpose
Opiate Antagonist Overdose, Opioid-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naloxone Auto-Injector
Sponsored by
About this trial
This is an interventional prevention trial for Opiate Antagonist Overdose focused on measuring Opioid-Related Disorders, Naloxone, Harm Reduction, Drug Overdose Deaths, Opioid Misuse, Naloxone Coprescribing, Universal Precautions, Opioid Substance Use Disorder
Eligibility Criteria
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.
Sites / Locations
- UNM Hospitals - Alcohol and Substance Abuse Program
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with opioid substance abuse disorders
Arm Description
All participants will receive Naloxone autoinjector as a preventative tool for accidental opioid overdose
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02669901
First Posted
December 21, 2015
Last Updated
September 6, 2022
Sponsor
University of New Mexico
Collaborators
Kaleo Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02669901
Brief Title
Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Substance Use Disorder
Official Title
Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Substance Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2016 (Actual)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
August 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
Kaleo Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Antagonist Overdose, Opioid-Related Disorders
Keywords
Opioid-Related Disorders, Naloxone, Harm Reduction, Drug Overdose Deaths, Opioid Misuse, Naloxone Coprescribing, Universal Precautions, Opioid Substance Use Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with opioid substance abuse disorders
Arm Type
Other
Arm Description
All participants will receive Naloxone autoinjector as a preventative tool for accidental opioid overdose
Intervention Type
Behavioral
Intervention Name(s)
Naloxone Auto-Injector
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
Patients on chronic opioid therapy will be co-prescribed a naloxone-autoinjector rescue kit to decrease the accidental overdose rate associated with these medications.
Time Frame
2 years
Title
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)
Description
Patients on chronic opioid therapy will be co-prescribed a naloxone-autoinjector rescue kit to decrease the accidental overdose rate associated with these medications.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
UNM Hospitals - Alcohol and Substance Abuse Program
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Substance Use Disorder
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