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Nasal Naloxone for Narcotic Overdose

Primary Purpose

Drug Overdose

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Intranasal (IN) naloxone

Intravenous (IV) naloxone

Intramuscular (IM) naloxone

Intraosseus (IO) naloxone

About this trial

This is an interventional treatment trial for Drug Overdose focused on measuring heroin, prescription pain killers, narcotics

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clermont County
Scioto County
Adams County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intranasal (IN) naloxone

Standard of Care (TAU)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of patients with adequate respiration within 10 minutes

Secondary Outcome Measures

Number of patients requiring second dose of naloxone

Time to first naloxone administration

Time between emergency call and administration of naloxone.

Opioid Withdrawal Symptoms

Naloxone Adverse Events

Proportion of Patients breathing unassisted upon arrival to the hospital

Days of hospitalization following naloxone administration

Mortality rate

Full Information

NCT ID

NCT01912573

First Posted

July 29, 2013

Last Updated

July 29, 2013

Sponsor

Judith Feinberg

1. Study Identification

Unique Protocol Identification Number

NCT01912573

Brief Title

Nasal Naloxone for Narcotic Overdose

Official Title

Nasal Naloxone for Narcotic Overdose

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Judith Feinberg

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Overdose

Keywords

heroin, prescription pain killers, narcotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intranasal (IN) naloxone

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of Care (TAU)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intranasal (IN) naloxone

Other Intervention Name(s)

Narcan

Intervention Type

Drug

Intervention Name(s)

Intravenous (IV) naloxone

Other Intervention Name(s)

Narcan

Intervention Type

Drug

Intervention Name(s)

Intramuscular (IM) naloxone

Other Intervention Name(s)

Narcan

Intervention Type

Drug

Intervention Name(s)

Intraosseus (IO) naloxone

Other Intervention Name(s)

Narcan

Primary Outcome Measure Information:

Title

Proportion of patients with adequate respiration within 10 minutes

Time Frame

10 minutes after intervention administration

Secondary Outcome Measure Information:

Title

Number of patients requiring second dose of naloxone

Time Frame

within 10 minutes of initial dose

Title

Time to first naloxone administration

Description

Time between emergency call and administration of naloxone.

Time Frame

at baseline

Title

Opioid Withdrawal Symptoms

Time Frame

baseline

Title

Naloxone Adverse Events

Time Frame

3 hours

Title

Proportion of Patients breathing unassisted upon arrival to the hospital

Time Frame

within 1 hour

Title

Days of hospitalization following naloxone administration

Time Frame

7 days

Title

Mortality rate

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith Feinberg, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clermont County

City

Batavia

State/Province

Ohio

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joe Renusch, MD

Facility Name

Scioto County

City

Portsmouth

State/Province

Ohio

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian Barhorst, MD

Facility Name

Adams County

City

West Union

State/Province

Ohio

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruce Ashley, MD

12. IPD Sharing Statement

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Nasal Naloxone for Narcotic Overdose

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