Morphinan Opioid OverdosePhase 2NCT01293058
Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
A Phase 2 study testing Intranasal naloxone and Intravenous in people with Morphinan Opioid Overdose, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which route of administration is better for treatment of opioid overdosed patients Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Morphinan Opioid Overdose
- What is being tested?
- Intranasal naloxone and Intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Mar 2007to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Not giving response to naloxone and suspicious to have another reason for loss of consciousness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Routs of Naloxone Administration for Opioid Overdosed Patients
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.
- Conditions
- Morphinan Opioid Overdose
- Being tested
- Intranasal naloxone, Intravenous
- Keywords
- opioid, overdose, naloxone, intranasal
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal naloxoneDrug
spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness
IntravenousDrug
Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness
| Study group | Role | What they receive |
|---|---|---|
| Intravenous | Other | The investigators administered intravenous naloxone for our opioid overdose patients Receives: Drug: Intravenous |
| Intranasal | Other | The investigators administered intranasal naloxone for treatment of our patients Receives: Drug: Intranasal naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of consciousness
The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration
Measured: 4 min after naloxone administration
Secondary outcomes (1)
blood pressure
The investigators evaluated blood pressure 4 minutes after naloxone administration
Measured: at 4 min after naloxone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startMar 2007
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morphinan Opioid OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Nastaran Izadi, A.Professor, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293058
- Sponsor's protocol ID
- ASD-1213-16
- Status last verified
- Mar 2007
- First submitted
- 9 Feb 2011
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Routs of Naloxone Administration for Opioid Overdosed Patients
- ClinicalTrials.gov ID
- NCT01293058
- Acronym / sponsor ID
- ASD-1213-16
- Conditions
- Morphinan Opioid Overdose
- Keywords
- opioid, overdose, naloxone, intranasal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous | Other | Drug: IntravenousThe investigators administered intravenous naloxone for our opioid overdose patients |
| Intranasal | Other | Drug: Intranasal naloxoneThe investigators administered intranasal naloxone for treatment of our patients |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with the range of 15-50 years old
Key exclusion criteria (1 listed)
- Not giving response to naloxone and suspicious to have another reason for loss of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal naloxonespray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness | Drug | Intranasal |
| IntravenousAmp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness | Drug | Intravenous |
Primary outcome
level of consciousness
Time frame: 4 min after naloxone administration
The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration
1 secondary outcome
blood pressure
Time frame: at 4 min after naloxone administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
- Isfahan university of medical sciencesLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nastaran Izadi, A.Professor principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal naloxone and Intravenous in people with Morphinan Opioid Overdose, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of consciousness (time frame: 4 min after naloxone administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2011.