Nasal Naloxone for Narcotic Overdose

Drug Overdose Clinical Trial

Official title:

Nasal Naloxone for Narcotic Overdose

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01912573
• Other study ID #: N3OD
• Secondary ID: Ohio Division of
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 29, 2013
• Last updated: July 29, 2013
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: July 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 236
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Drug Overdose

Intervention

Drug:
• Intranasal (IN) naloxone

• Intravenous (IV) naloxone

• Intramuscular (IM) naloxone

• Intraosseus (IO) naloxone

Locations

Country	Name	City	State
United States	Clermont County	Batavia	Ohio
United States	Scioto County	Portsmouth	Ohio
United States	Adams County	West Union	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Judith Feinberg

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with adequate respiration within 10 minutes		10 minutes after intervention administration	Yes
Secondary	Number of patients requiring second dose of naloxone		within 10 minutes of initial dose	Yes
Secondary	Time to first naloxone administration	Time between emergency call and administration of naloxone.	at baseline	No
Secondary	Opioid Withdrawal Symptoms		baseline	No
Secondary	Naloxone Adverse Events		3 hours	Yes
Secondary	Proportion of Patients breathing unassisted upon arrival to the hospital		within 1 hour	No
Secondary	Days of hospitalization following naloxone administration		7 days	No
Secondary	Mortality rate		7 days	Yes