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Nasal Naloxone for Narcotic Overdose

NCT01912573 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2013-07-31

No results posted yet for this study

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.

Conditions

  • Drug Overdose

Interventions

DRUG

Intranasal (IN) naloxone

DRUG

Intravenous (IV) naloxone

DRUG

Intramuscular (IM) naloxone

DRUG

Intraosseus (IO) naloxone

Sponsors & Collaborators

  • Judith Feinberg

    lead OTHER

Principal Investigators

  • Judith Feinberg, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-30
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01912573 on ClinicalTrials.gov