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Nasal Naloxone for Narcotic Overdose

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by University of Cincinnati.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Judith Feinberg, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01912573
First received: July 29, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Drug Overdose
Drug: Intranasal (IN) naloxone
Drug: Intravenous (IV) naloxone
Drug: Intramuscular (IM) naloxone
Drug: Intraosseus (IO) naloxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nasal Naloxone for Narcotic Overdose

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Proportion of patients with adequate respiration within 10 minutes [ Time Frame: 10 minutes after intervention administration ]

Secondary Outcome Measures:
  • Number of patients requiring second dose of naloxone [ Time Frame: within 10 minutes of initial dose ]
  • Time to first naloxone administration [ Time Frame: at baseline ]
    Time between emergency call and administration of naloxone.

  • Opioid Withdrawal Symptoms [ Time Frame: baseline ]
  • Naloxone Adverse Events [ Time Frame: 3 hours ]
  • Proportion of Patients breathing unassisted upon arrival to the hospital [ Time Frame: within 1 hour ]
  • Days of hospitalization following naloxone administration [ Time Frame: 7 days ]
  • Mortality rate [ Time Frame: 7 days ]

Estimated Enrollment: 236
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal (IN) naloxone
Intranasal (IN) naloxone as initial response to suspected opioid overdose
Drug: Intranasal (IN) naloxone
Other Name: Narcan
Active Comparator: Standard of Care (TAU)
Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose.
Drug: Intravenous (IV) naloxone
Other Name: Narcan
Drug: Intramuscular (IM) naloxone
Other Name: Narcan
Drug: Intraosseus (IO) naloxone
Other Name: Narcan

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.
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912573

Locations
United States, Ohio
Clermont County Not yet recruiting
Batavia, Ohio, United States
Contact: Joe Renusch, MD         
Scioto County Not yet recruiting
Portsmouth, Ohio, United States
Contact: Brian Barhorst, MD         
Adams County Not yet recruiting
West Union, Ohio, United States
Contact: Bruce Ashley, MD         
Sponsors and Collaborators
Judith Feinberg
Investigators
Principal Investigator: Judith Feinberg, MD University of Cincinnati
  More Information

Responsible Party: Judith Feinberg, Assoc Chair of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01912573     History of Changes
Other Study ID Numbers: N3OD
Ohio Division of EMS Board ( Other Grant/Funding Number: Ohio Department of Public Safety )
Study First Received: July 29, 2013
Last Updated: July 29, 2013

Keywords provided by University of Cincinnati:
heroin
prescription pain killers
narcotics

Additional relevant MeSH terms:
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Narcotics
Naloxone
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on May 23, 2017