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Drug Overdose | Nasal Naloxone for Narcotic Overdose

Drug Overdose research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Drug Overdose

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Intranasal (IN) naloxone

Drug:Intravenous (IV) naloxone

Drug:Intramuscular (IM) naloxone

Drug:Intraosseus (IO) naloxone

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Unknown status

Start Date: September 2013

Completed Date: March 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Proportion of patients with adequate respiration within 10 minutes

Secondary Outcome: Number of patients requiring second dose of naloxone

Study sponsors, principal investigator, and references

Principal Investigator: Judith Feinberg, MD

Lead Sponsor: Judith Feinberg

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01912573

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