Nasal Naloxone for Narcotic Overdose

NCT01912573 — Phase 4, Unknown, 236 participants, Judith Feinberg

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Registry	NCT01912573
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	236 (Estimated)
Sponsor	Judith Feinberg (Other)
Conditions	Drug Overdose
Interventions	Intranasal (IN) naloxone, Intravenous (IV) naloxone, Intramuscular (IM) naloxone, Intraosseus (IO) naloxone (Drug)
Dates	start 2013-09-01, primary completion 2014-09-01 (estimated), completion 2015-03-01 (estimated), first posted 2013-07-31, last updated 2013-07-31
Locations	3 sites in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intranasal (IN) naloxone	Experimental	Drug: Intranasal (IN) naloxone	Intranasal (IN) naloxone as initial response to suspected opioid overdose
Standard of Care (TAU)	Active comparator	Drug: Intravenous (IV) naloxone; Drug: Intramuscular (IM) naloxone; Drug: Intraosseus (IO) naloxone	Standard of care (intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\]delivery of naloxone) as initial response to suspected opioid overdose.

Intranasal (IN) naloxone (Drug), also known as Narcan
Intravenous (IV) naloxone (Drug), also known as Narcan
Intramuscular (IM) naloxone (Drug), also known as Narcan
Intraosseus (IO) naloxone (Drug), also known as Narcan

+Outcome measures

Primary outcomes

Proportion of patients with adequate respiration within 10 minutes [10 minutes after intervention administration]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 12 Years to any

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 (3)

Facility	City	Country
Clermont County	Batavia, Ohio	United States
Scioto County	Portsmouth, Ohio	United States
Adams County	West Union, Ohio	United States

+Investigators

Judith Feinberg, MD, Principal investigator, University of Cincinnati