Nasal Naloxone for Narcotic Overdose

Study Overview
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Brief Summary
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The goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO) methods.

Detailed Description
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This is a randomized, prospective trial that will compare clinical outcomes for parenteral naloxone according to the standard of care (TAU; administration via intravenous [IV], intramuscular [IM] or intraosseus [IO] delivery) versus intranasal [IN] for the prehospital emergency treatment of suspected opioid overdose. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to administer either standard care or IN naloxone as the initial response to a suspected opioid overdose.

Official Title
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Nasal Naloxone for Narcotic Overdose

Conditions
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Drug Overdose

Intervention / Treatment
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* Drug: Intranasal (IN) naloxone
* Drug: Intravenous (IV) naloxone
* Drug: Intramuscular (IM) naloxone
* Drug: Intraosseus (IO) naloxone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of hyperventilation or respiratory arrest OR EMS assessment that the person needs naloxone for possible opioid or unknown drug overdose Exclusion Criteria: EMS assessment that the participant is less than 12 years old

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal (IN) naloxone<br>Intranasal (IN) naloxone as initial response to suspected opioid overdose | Drug: Intranasal (IN) naloxone<br> <br> * Other names: Narcan;|
| Active Comparator: Standard of Care (TAU)<br>Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose. | Drug: Intravenous (IV) naloxone<br> <br> * Other names: Narcan;Drug: Intramuscular (IM) naloxone<br> <br> * Other names: Narcan;Drug: Intraosseus (IO) naloxone<br> <br> * Other names: Narcan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with adequate respiration within 10 minutes |  | 10 minutes after intervention administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients requiring second dose of naloxone |  | within 10 minutes of initial dose | 
| Time to first naloxone administration | Time between emergency call and administration of naloxone. | at baseline | 
| Opioid Withdrawal Symptoms |  | baseline | 
| Naloxone Adverse Events |  | 3 hours | 
| Proportion of Patients breathing unassisted upon arrival to the hospital |  | within 1 hour | 
| Days of hospitalization following naloxone administration |  | 7 days | 
| Mortality rate |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heroin, prescription pain killers, narcotics