Nasal Naloxone for Narcotic Overdose

Judith Feinberg

Status and phase: Unknown; Phase 4

Conditions: Drug Overdose

Treatments: Drug: Intramuscular (IM) naloxone; Drug: Intranasal (IN) naloxone; Drug: Intraosseus (IO) naloxone; Drug: Intravenous (IV) naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT01912573

N3OD

Ohio Division of EMS Board (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Intranasal (IN) naloxone

Experimental group

Description:

Intranasal (IN) naloxone as initial response to suspected opioid overdose

Treatment:

Drug: Intranasal (IN) naloxone

Standard of Care (TAU)

Active Comparator group

Description:

Standard of care (intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\]delivery of naloxone) as initial response to suspected opioid overdose.

Treatment:

Drug: Intravenous (IV) naloxone

Drug: Intraosseus (IO) naloxone

Drug: Intramuscular (IM) naloxone