Drug OverdosePhase 2NCT01939444
A Pilot Study of the Bioavailability of Nasal Naloxone
A Phase 2 study testing naloxone intranasal and naloxone intravenous in people with Drug Overdose, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters: Preliminary estimation of bioavailability of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Drug Overdose
- What is being tested?
- naloxone intranasal and naloxone intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Nov 2014
- 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
- informed consent
Who cannot join
- history of liver disease
- taking any medications including herbal medicines the last week history of drug abuse
- any local nasal disease or nasal surgery or recent cold for the last week
- any history of drug allergies
Trial locations and contacts
1 site in 1 country.
About this study
The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:
- Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers
- Preliminary estimation of the maximum serum concentration (Cmax) of this formulation
- Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation
- Safety of the formulation
- Conditions
- Drug Overdose
- Being tested
- naloxone intranasal, naloxone intravenous
- Keywords
- Antidotes, naloxone, administration, intravenous, administration, intranasal, pharmacology
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naloxone intranasalDrug
If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally
naloxone intravenousDrug
The parenteral dose reflects clinically used doses for overdoses (0.4 - 1.0 mg). A washout period of at least 3 days between each intervention. IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position
| Study group | Role | What they receive |
|---|---|---|
| naloxone intranasal | Experimental | 2.0 mg by the nasal route Receives: Drug: naloxone intranasal |
| naloxone intravenous | Active comparator | 1.0 mg intravenous Receives: Drug: naloxone intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
preliminary bioavailability of nasal naloxone
measured as ratio of area under the time concentration curve for nasal over intravenous naloxone x 100. Plasma concentration data will be analyzed by non-compartmental techniques.
Measured: 2 weeks
Secondary outcomes (2)
time to maximum concentrations
Measured: 2 weeks
maximum concentration
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug OverdoseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University of Iceland
- Responsible party
- Sponsor
- Investigators
- Øyvind Ellingsen, MD PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939444
- Sponsor's protocol ID
- OPI-12-001
- Other IDs
- 2012-004989-18
- Status last verified
- Oct 2021
- First submitted
- 2 Sep 2013
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen. 2019 Sep 23;139(13). doi: 10.4045/tidsskr.19.0162. Print 2019 Sep 24. English, Norwegian.
PubMed 31556537
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Bioavailability of Nasal Naloxone
- ClinicalTrials.gov ID
- NCT01939444
- Acronym / sponsor ID
- OPI-12-001
- Conditions
- Drug Overdose
- Keywords
- Antidotes, naloxone, administration, intravenous, administration, intranasal, pharmacology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University of Iceland
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Sep 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 overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:
- Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers
- Preliminary estimation of the maximum serum concentration (Cmax) of this formulation
- Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation
- Safety of the formulation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naloxone intranasal | Experimental | Drug: naloxone intranasal2.0 mg by the nasal route |
| naloxone intravenous | Active comparator | Drug: naloxone intravenous1.0 mg intravenous |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
- informed consent
Key exclusion criteria (4 listed)
- history of liver disease
- taking any medications including herbal medicines the last week history of drug abuse
- any local nasal disease or nasal surgery or recent cold for the last week
- any history of drug allergies
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 |
|---|---|---|
| naloxone intranasalIf bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally | Drug | naloxone intranasal |
| naloxone intravenousThe parenteral dose reflects clinically used doses for overdoses (0.4 - 1.0 mg). A washout period of at least 3 days between each intervention. IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position | Drug | naloxone intravenous |
Primary outcome
preliminary bioavailability of nasal naloxone
Time frame: 2 weeks
measured as ratio of area under the time concentration curve for nasal over intravenous naloxone x 100. Plasma concentration data will be analyzed by non-compartmental techniques.
2 secondary outcomes
time to maximum concentrations
Time frame: 2 weeks
maximum concentration
Time frame: 2 weeks
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 3 Nov 2021.
- Results publication: PubMed 31556537Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen. 2019 Sep 23;139(13). doi: 10.4045/tidsskr.19.0162. Print 2019 Sep 24. English, Norwegian.
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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.
Øyvind Ellingsen, MD PhD study director
Norwegian University of Science and Technology
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 naloxone intranasal and naloxone intravenous in people with Drug Overdose, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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 3 Nov 2021. 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 Norway. 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?
preliminary bioavailability of nasal naloxone (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01939444, which also lists 1 linked publication.
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 3 Nov 2021.