NCT01912573

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
236

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

July 29, 2013

Last Update Submit

July 29, 2013

Conditions

Drug Overdose

Keywords

heroinprescription pain killersnarcotics

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with adequate respiration within 10 minutes

    10 minutes after intervention administration

Secondary Outcomes (7)

  • Number of patients requiring second dose of naloxone

    within 10 minutes of initial dose

  • Time to first naloxone administration

    at baseline

  • Opioid Withdrawal Symptoms

    baseline

  • Naloxone Adverse Events

    3 hours

  • Proportion of Patients breathing unassisted upon arrival to the hospital

    within 1 hour

  • +2 more secondary outcomes

Study Arms (2)

Intranasal (IN) naloxone

EXPERIMENTAL

Intranasal (IN) naloxone as initial response to suspected opioid overdose

Drug: Intranasal (IN) naloxone

Standard of Care (TAU)

ACTIVE COMPARATOR

Standard of care (intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\]delivery of naloxone) as initial response to suspected opioid overdose.

Drug: Intravenous (IV) naloxoneDrug: Intramuscular (IM) naloxoneDrug: Intraosseus (IO) naloxone

Interventions

Intranasal (IN) naloxoneDRUG
Also known as: Narcan
Intranasal (IN) naloxone
Intravenous (IV) naloxoneDRUG
Also known as: Narcan
Standard of Care (TAU)
Intramuscular (IM) naloxoneDRUG
Also known as: Narcan
Standard of Care (TAU)
Intraosseus (IO) naloxoneDRUG
Also known as: Narcan
Standard of Care (TAU)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of hyperventilation or respiratory arrest OR
  • EMS assessment that the person needs naloxone for possible opioid or unknown drug overdose

You may not qualify if:

  • EMS assessment that the participant is less than 12 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clermont County

Batavia, Ohio, United States

Location

Scioto County

Portsmouth, Ohio, United States

Location

Adams County

West Union, Ohio, United States

Location

MeSH Terms

Conditions

Drug Overdose

Interventions

NaloxoneInjections, IntramuscularJupiter

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsInjectionsDrug Administration RoutesDrug TherapyTherapeuticsPlanetsSolar SystemAstronomical ObjectsAstronomical PhenomenaPhysical Phenomena

Study Officials

  • Judith Feinberg, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc Chair of Medicine

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(3)