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Nasal Naloxone for Narcotic Overdose

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Overdose

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

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Judith Feinberg

Official(s) and/or principal investigator(s):
Judith Feinberg, MD, Principal Investigator, Affiliation: University of Cincinnati

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.

Clinical Details

Official title: Nasal Naloxone for Narcotic Overdose

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Number of patients requiring second dose of naloxone

Time to first naloxone administration

Opioid Withdrawal Symptoms

Naloxone Adverse Events

Proportion of Patients breathing unassisted upon arrival to the hospital

Days of hospitalization following naloxone administration

Mortality rate

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.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Clermont County, Batavia, Ohio, United States; Not yet recruiting
Joe Renusch, MD

Scioto County, Portsmouth, Ohio, United States; Not yet recruiting
Brian Barhorst, MD

Adams County, West Union, Ohio, United States; Not yet recruiting
Bruce Ashley, MD

Additional Information

Starting date: September 2013
Last updated: July 29, 2013

Page last updated: August 23, 2015

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