NCT01293058

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
Last Updated

February 10, 2011

Status Verified

March 1, 2007

Enrollment Period

3 months

First QC Date

February 9, 2011

Last Update Submit

February 9, 2011

Conditions

Morphinan Opioid Overdose

Keywords

opioidoverdosenaloxoneintranasal

Outcome Measures

Primary Outcomes (1)

  • level of consciousness

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

    4 min after naloxone administration

Secondary Outcomes (1)

  • blood pressure

    at 4 min after naloxone administration

Study Arms (2)

Intravenous

OTHER

The investigators administered intravenous naloxone for our opioid overdose patients

Drug: Intravenous

Intranasal

OTHER

The investigators administered intranasal naloxone for treatment of our patients

Drug: Intranasal naloxone

Interventions

Intranasal naloxoneDRUG

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

Intranasal
IntravenousDRUG

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

Intravenous

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noor university hospital

Isfahan, Isfahan, Iran

Location

Related Links

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Nastaran Izadi, A.Professor

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

March 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 10, 2011

Record last verified: 2007-03

Locations

IR(1)