Nasal Naloxone for Narcotic Overdose

Phase 4

• Conditions: Drug Overdose
• Interventions: Drug: Intranasal (IN) naloxone; Drug: Intravenous (IV) naloxone; Drug: Intramuscular (IM) naloxone; Drug: Intraosseus (IO) naloxone

• Registration Number: NCT01912573
• Lead Sponsor: Judith Feinberg

Brief Summary

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

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.

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-29
• Last Update Submitted: 2013-07-29
• Study First Posted: 2013-07-31
• Last Update Posted: 2013-07-31
• Study Start: 2013-09
• Primary Completion: 2014-09
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal (IN) naloxone	Intranasal (IN) naloxone	Intranasal (IN) naloxone as initial response to suspected opioid overdose
Standard of Care (TAU)	Intravenous (IV) naloxone	Standard of care (intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\]delivery of naloxone) as initial response to suspected opioid overdose.
Standard of Care (TAU)	Intramuscular (IM) naloxone	Standard of care (intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\]delivery of naloxone) as initial response to suspected opioid overdose.
Standard of Care (TAU)	Intraosseus (IO) naloxone	Standard of care (intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\]delivery of naloxone) as initial response to suspected opioid overdose.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with adequate respiration within 10 minutes	10 minutes after intervention administration

Secondary Outcome Measures

Name	Time	Method
Number of patients requiring second dose of naloxone	within 10 minutes of initial dose
Time to first naloxone administration	at baseline	Time between emergency call and administration of naloxone.
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

Trial Locations

Locations (3)

Scioto County; 🇺🇸 Portsmouth, Ohio, United States

Adams County; 🇺🇸 West Union, Ohio, United States

Clermont County; 🇺🇸 Batavia, Ohio, United States