Opioid-use DisorderPhase 1NCT03386591
Comparison of Naloxone Pharmacokinetics
A Phase 1 study testing Naloxone, Mucosal atomization device and syringe and Narcan in people with Opioid-use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Naloxone, Mucosal atomization device and syringe and Narcan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 6 Mar 2018
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18 to 55 years of age, inclusive
- Provide written informed consent
- BMI ranging from 18 to 32 kg/m2, inclusive
- Adequate venous access
- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG
- Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration
- Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited
- Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study
Who cannot join
- Contact site directly for more information
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.
- Conditions
- Opioid-use Disorder
- Being tested
- Naloxone, Mucosal atomization device and syringe, Narcan, Intramuscular Auto Injector
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaloxoneDrug
Comparing pharmacokinetics of naloxone
Mucosal atomization device and syringeDevice
Injection
NarcanDevice
Nasal Spray
Intramuscular Auto InjectorDevice
Also called Evzio
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Mucosal Atomization (1 administration) | Experimental | One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril) Receives: Drug: Naloxone; Device: Mucosal atomization device and syringe |
| Mucosal Atomization (2 administrations) | Experimental | Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart Receives: Drug: Naloxone; Device: Mucosal atomization device and syringe |
| Narcan 2mg | Experimental | One Intranasal administration of 2 mg naloxone using Narcan nasal spray Receives: Drug: Naloxone; Device: Narcan |
| Narcan 4mg | Experimental | One Intranasal administration of 4 mg naloxone using Narcan nasal spray Receives: Drug: Naloxone; Device: Narcan |
| Intramuscular auto injector | Experimental | One Intramuscular administration of 2 mg naloxone using Evzio auto-injector Receives: Drug: Naloxone; Device: Intramuscular Auto Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of naloxone
Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve
Measured: 11 days
Secondary outcomes (1)
Safety Assessments
Number of participants with AEs, vital signs, ECG, laboratory changes and nasal irritation following the administration of naloxone.
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start3 Jan 2018
- Primary completion8 Feb 2018
- Study completion6 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra Kelsh, MD, Principal investigator, Vince and Associates Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386591
- Sponsor's protocol ID
- Naloxone P1a-003
- Status last verified
- Mar 2018
- First submitted
- 18 Dec 2017
- Last updated
- 9 Mar 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices
- ClinicalTrials.gov ID
- NCT03386591
- Acronym / sponsor ID
- Naloxone P1a-003
- Conditions
- Opioid-use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 29 Dec 2017 (actual)
- 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.
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.
| Arm | Type | Receives |
|---|---|---|
| Mucosal Atomization (1 administration) | Experimental | Drug: Naloxone, Device: Mucosal atomization device and syringeOne Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril) |
| Mucosal Atomization (2 administrations) | Experimental | Drug: Naloxone, Device: Mucosal atomization device and syringeTwo Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart |
| Narcan 2mg | Experimental | Drug: Naloxone, Device: NarcanOne Intranasal administration of 2 mg naloxone using Narcan nasal spray |
| Narcan 4mg | Experimental | Drug: Naloxone, Device: NarcanOne Intranasal administration of 4 mg naloxone using Narcan nasal spray |
| Intramuscular auto injector | Experimental | Drug: Naloxone, Device: Intramuscular Auto InjectorOne Intramuscular administration of 2 mg naloxone using Evzio auto-injector |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females 18 to 55 years of age, inclusive
- Provide written informed consent
- BMI ranging from 18 to 32 kg/m2, inclusive
- Adequate venous access
- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG
Key exclusion criteria (1 listed)
- Contact site directly for more information
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 |
|---|---|---|
| NaloxoneComparing pharmacokinetics of naloxone | Drug | Intramuscular auto injector, Mucosal Atomization (1 administration), Mucosal Atomization (2 administrations), Narcan 2mg, Narcan 4mg |
| Mucosal atomization device and syringeInjection | Device | Mucosal Atomization (1 administration), Mucosal Atomization (2 administrations) |
| NarcanNasal Spray | Device | Narcan 2mg, Narcan 4mg |
| Intramuscular Auto InjectorAlso: EvzioIntramuscular injection | Device | Intramuscular auto injector |
Primary outcome
Pharmacokinetic parameters of naloxone
Time frame: 11 days
Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve
1 secondary outcome
Safety Assessments
Time frame: 16 days
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 9 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Debra Kelsh, MD principal investigator
Vince and Associates Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naloxone, Mucosal atomization device and syringe and Narcan in people with Opioid-use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site 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 8 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 9 Mar 2018. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic parameters of naloxone (time frame: 11 days). 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 9 Mar 2018.