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Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01293058
First received: February 9, 2011
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

The purpose of this study is to determine which route of administration is better for treatment of opioid overdosed patients


Condition Intervention Phase
Morphinan Opioid Overdose
Drug: Intranasal naloxone
Drug: Intravenous
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Routs of Naloxone Administration for Opioid Overdosed Patients

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • level of consciousness [ Time Frame: 4 min after naloxone administration ] [ Designated as safety issue: Yes ]
    The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration


Secondary Outcome Measures:
  • blood pressure [ Time Frame: at 4 min after naloxone administration ] [ Designated as safety issue: Yes ]
    The investigators evaluated blood pressure 4 minutes after naloxone administration


Enrollment: 100
Study Start Date: March 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intravenous
The investigators administered intravenous naloxone for our opioid overdose patients
Drug: Intravenous
Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness
Intranasal
The investigators administered intranasal naloxone for treatment of our patients
Drug: Intranasal naloxone
spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness

Detailed Description:

In intravenous drug abusers (IDUs), as a result of previous intravenous substance abuse, the predictable difficult cannulate exist and cause the delay administration of antidote therapy. Additionally, IDUs are also at increased risk of carrying blood borne infections that could be transmitted to healthcare workers through needle stick injuries. The investigators aimed to compare intranasal administration of naloxone with intravenous route.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with the range of 15-50 years old

    • Who were suspicious to opioid overdoses based on history and having clinical appearance such as miotic pupils with loss of consciousness
    • Give response to naloxone with increasing the level of consciousness

Exclusion Criteria:

  • Not giving response to naloxone and suspicious to have another reason for loss of consciousness
  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: NCT01293058

Locations
Iran, Islamic Republic of
Noor university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Nastaran Izadi, A.Professor Isfahan University of Medical Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01293058     History of Changes
Other Study ID Numbers: ASD-1213-16
Study First Received: February 9, 2011
Last Updated: February 9, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
opioid
overdose
naloxone
intranasal

Additional relevant MeSH terms:
Drug Overdose
Chemically-Induced Disorders
Substance-Related Disorders
Naloxone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014