Drug Overdose | Nasal Naloxone for Narcotic Overdose
Drug Overdose research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Intranasal (IN) naloxone
Drug:Intravenous (IV) naloxone
Drug:Intramuscular (IM) naloxone
Drug:Intraosseus (IO) naloxone
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Intranasal (IN) naloxoneIntranasal (IN) naloxone as initial response to suspected opioid overdose
Standard of Care (TAU)Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose.
Start Date: September 2013
Completed Date: March 2015
Phase: Phase 4
Primary Outcome: Proportion of patients with adequate respiration within 10 minutes
Secondary Outcome: Number of patients requiring second dose of naloxone
Study sponsors, principal investigator, and references
Principal Investigator: Judith Feinberg, MD
Lead Sponsor: Judith Feinberg