Randomized Trial of Intranasal Versus Intravenous Naloxon... | NCT01293058

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

NCT01293058

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Feb 10, 2011Estimated

Enrollment

100Actual

Phase

Phase 2

Conditions

Morphinan Opioid Overdose

Interventions

Intranasal naloxone
Intravenous

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Feb 9, 2011

First Submission Date that Met QC Criteria

Feb 9, 2011

First Posted Date

Feb 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2011

Last Update Posted Date

Feb 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intranasal naloxone	Drug	spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness	Intranasal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
blood pressure	The investigators evaluated blood pressure 4 minutes after naloxone administration	at 4 min after naloxone administration

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nastaran Izadi, A.Professor	Isfahan University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Noor university hospital		Isfahan	Isfahan		Iran

Label	URL
Isfahan university of medical sciences	View source

Condition Browse Module

MeSH Terms

ID	Term
D062787	Drug Overdose

Ancestor Terms

ID	Term
D063487	Prescription Drug Misuse
D000076064	Drug Misuse
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided