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

Study Overview
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Brief Summary
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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.

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

Conditions
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Opiate Antagonist Overdose, Opioid-Related Disorders

Intervention / Treatment
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* Behavioral: Naloxone Auto-Injector


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with opioid substance abuse disorders<br>All participants will receive Naloxone autoinjector as a preventative tool for accidental opioid overdose | Behavioral: Naloxone Auto-Injector<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid-Related Disorders, Naloxone, Harm Reduction, Drug Overdose Deaths, Opioid Misuse, Naloxone Coprescribing, Universal Precautions, Opioid Substance Use Disorder