Nasal Naloxone for Narcotic Overdose

July 29, 2013 updated by: Judith Feinberg
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

236

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Batavia, Ohio, United States
        • Clermont County
        • Contact:
          • Joe Renusch, MD
      • Portsmouth, Ohio, United States
        • Scioto County
        • Contact:
          • Brian Barhorst, MD
      • West Union, Ohio, United States
        • Adams County
        • Contact:
          • Bruce Ashley, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intranasal (IN) naloxone
Intranasal (IN) naloxone as initial response to suspected opioid overdose
Drug: Intranasal (IN) naloxone
Other Names:
  • Narcan
ACTIVE_COMPARATOR: Standard of Care (TAU)
Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose.
Drug: Intravenous (IV) naloxone
Other Names:
  • Narcan
Drug: Intramuscular (IM) naloxone
Other Names:
  • Narcan
Drug: Intraosseus (IO) naloxone
Other Names:
  • Narcan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Judith Feinberg

Investigators

  • Principal Investigator: Judith Feinberg, MD, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (ESTIMATE)

July 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N3OD
  • Ohio Division of EMS Board (OTHER_GRANT: Ohio Department of Public Safety)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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