Drug OverdosePhase 4NCT01912573
Nasal Naloxone for Narcotic Overdose
A Phase 4 study testing Intranasal (IN) naloxone, Intravenous (IV) naloxone and Intramuscular (IM) naloxone in people with Drug Overdose, run by Judith Feinberg at 3 sites in United States.
Trial summary
The goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Drug Overdose
- What is being tested?
- Intranasal (IN) naloxone, Intravenous (IV) naloxone and Intramuscular (IM) naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2013to Mar 2015
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of hyperventilation or respiratory arrest OR
- EMS assessment that the person needs naloxone for possible opioid or unknown drug overdose
Who cannot join
- EMS assessment that the participant is less than 12 years old
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clermont County
Batavia, Ohio
Joe Renusch, MD
Scioto County
Portsmouth, Ohio
Brian Barhorst, MD
Adams County
West Union, Ohio
Bruce Ashley, MD
About this study
The goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO) methods.
Read the detailed description
This is a randomized, prospective trial that will compare clinical outcomes for parenteral naloxone according to the standard of care (TAU; administration via intravenous [IV], intramuscular [IM] or intraosseus [IO] delivery) versus intranasal [IN] for the prehospital emergency treatment of suspected opioid overdose. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to administer either standard care or IN naloxone as the initial response to a suspected opioid overdose.
- Conditions
- Drug Overdose
- Being tested
- Intranasal (IN) naloxone, Intravenous (IV) naloxone, Intramuscular (IM) naloxone, Intraosseus (IO) naloxone
- Keywords
- heroin, prescription pain killers, narcotics
- 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 (IN) naloxoneDrug
Also called Narcan
Intravenous (IV) naloxoneDrug
Also called Narcan
Intramuscular (IM) naloxoneDrug
Also called Narcan
Intraosseus (IO) naloxoneDrug
Also called Narcan
| Study group | Role | What they receive |
|---|---|---|
| Intranasal (IN) naloxone | Experimental | Intranasal (IN) naloxone as initial response to suspected opioid overdose Receives: Drug: Intranasal (IN) naloxone |
| Standard of Care (TAU) | Active comparator | Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose. Receives: Drug: Intravenous (IV) naloxone; Drug: Intramuscular (IM) naloxone; Drug: Intraosseus (IO) naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adequate respiration within 10 minutes
Measured: 10 minutes after intervention administration
Secondary outcomes (7)
Number of patients requiring second dose of naloxone
Measured: within 10 minutes of initial dose
Time to first naloxone administration
Time between emergency call and administration of naloxone.
Measured: at baseline
Opioid Withdrawal Symptoms
Measured: baseline
Naloxone Adverse Events
Measured: 3 hours
Proportion of Patients breathing unassisted upon arrival to the hospital
Measured: within 1 hour
Days of hospitalization following naloxone administration
Measured: 7 days
Mortality rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Judith Feinberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Judith Feinberg, University of Cincinnati
- Investigators
- Judith Feinberg, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912573
- Sponsor's protocol ID
- N3OD
- Other IDs
- Ohio Division of EMS Board
- Status last verified
- Jul 2013
- First submitted
- 29 Jul 2013
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Naloxone for Narcotic Overdose
- ClinicalTrials.gov ID
- NCT01912573
- Acronym / sponsor ID
- N3OD
- Conditions
- Drug Overdose
- Keywords
- heroin, prescription pain killers, narcotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Judith FeinbergUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 31 Jul 2013 (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 goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO) methods.
Detailed description
This is a randomized, prospective trial that will compare clinical outcomes for parenteral naloxone according to the standard of care (TAU; administration via intravenous [IV], intramuscular [IM] or intraosseus [IO] delivery) versus intranasal [IN] for the prehospital emergency treatment of suspected opioid overdose. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to administer either standard care or IN naloxone as the initial response to a suspected opioid overdose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal (IN) naloxone | Experimental | Drug: Intranasal (IN) naloxoneIntranasal (IN) naloxone as initial response to suspected opioid overdose |
| Standard of Care (TAU) | Active comparator | Drug: Intravenous (IV) naloxone, Drug: Intramuscular (IM) naloxone, Drug: Intraosseus (IO) naloxoneStandard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of hyperventilation or respiratory arrest OR
- EMS assessment that the person needs naloxone for possible opioid or unknown drug overdose
Key exclusion criteria (1 listed)
- EMS assessment that the participant is less than 12 years old
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 (IN) naloxoneAlso: Narcan | Drug | Intranasal (IN) naloxone |
| Intravenous (IV) naloxoneAlso: Narcan | Drug | Standard of Care (TAU) |
| Intramuscular (IM) naloxoneAlso: Narcan | Drug | Standard of Care (TAU) |
| Intraosseus (IO) naloxoneAlso: Narcan | Drug | Standard of Care (TAU) |
Primary outcome
Proportion of patients with adequate respiration within 10 minutes
Time frame: 10 minutes after intervention administration
7 secondary outcomes
Number of patients requiring second dose of naloxone
Time frame: within 10 minutes of initial dose
Time to first naloxone administration
Time frame: at baseline
Opioid Withdrawal Symptoms
Time frame: baseline
Naloxone Adverse Events
Time frame: 3 hours
Proportion of Patients breathing unassisted upon arrival to the hospital
Time frame: within 1 hour
Days of hospitalization following naloxone administration
Time frame: 7 days
Mortality rate
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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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.
Judith Feinberg, MD principal investigator
University of Cincinnati
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intranasal (IN) naloxone, Intravenous (IV) naloxone and Intramuscular (IM) naloxone in people with Drug Overdose, run by Judith Feinberg at 3 sites in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Proportion of patients with adequate respiration within 10 minutes (time frame: 10 minutes after intervention 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 31 Jul 2013.