MedDataX Logo

Nasal Naloxone for Narcotic Overdose

NCT ID: NCT01912573

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Drug Overdose

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

heroin prescription pain killers narcotics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intranasal (IN) naloxone

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

Group Type EXPERIMENTAL

Intranasal (IN) naloxone

Intervention Type DRUG

Standard of Care (TAU)

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

Group Type ACTIVE_COMPARATOR

Intravenous (IV) naloxone

Intervention Type DRUG

Intramuscular (IM) naloxone

Intervention Type DRUG

Intraosseus (IO) naloxone

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intranasal (IN) naloxone

Intervention Type DRUG

Intravenous (IV) naloxone

Intervention Type DRUG

Intramuscular (IM) naloxone

Intervention Type DRUG

Intraosseus (IO) naloxone

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Narcan Narcan Narcan Narcan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Judith Feinberg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Judith Feinberg

Assoc Chair of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judith Feinberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clermont County

Batavia, Ohio, United States

Site Status

Scioto County

Portsmouth, Ohio, United States

Site Status

Adams County

West Union, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Joe Renusch, MD

Role: primary

Brian Barhorst, MD

Role: primary

Bruce Ashley, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ohio Division of EMS Board

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N3OD

Identifier Type: -

Identifier Source: org_study_id