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CompletedNCT01293058Updated Feb 10, 2011

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

A Phase 2 interventional study of Intranasal naloxone and Intravenous in Morphinan Opioid Overdose, sponsored by Isfahan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 15 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-10.

Sponsored by Isfahan University of Medical Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
15 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Morphinan Opioid Overdose

Keywords

  • opioid
  • overdose
  • naloxone
  • intranasal
03

In context

Drug Overdose

139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 98 interventional studies indexed under Drug Overdose.

Browse Drug Overdose studies →

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Not giving response to naloxone and suspicious to have another reason for loss of consciousness
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Other
    Intravenous

    The investigators administered intravenous naloxone for our opioid overdose patients

    Drug: Intravenous

  • Other
    Intranasal

    The investigators administered intranasal naloxone for treatment of our patients

    Drug: Intranasal naloxone

Interventions

  • DrugIntranasal naloxone

    spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness

  • DrugIntravenous

    Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness

06

What researchers measure

Primary outcomes

  1. level of consciousness

    The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration

    Time frame: 4 min after naloxone administration

Secondary outcomes

  1. blood pressure

    The investigators evaluated blood pressure 4 minutes after naloxone administration

    Time frame: at 4 min after naloxone administration

07

Study locations

1 site
  • Noor university hospital
    Isfahan, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01293058
Lead sponsor
Isfahan University of Medical Sciences
First posted
Feb 10, 2011
Start date
Mar 2007
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Feb 10, 2011

Study contacts

Nastaran Izadi, A.Professor
principal investigator · Isfahan University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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