Overdose AntidoteEarly Phase 1NCT05099614
Naloxone Auto-injection in Healthy Volunteers
A Early Phase 1 study testing Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system in people with Overdose Antidote, run by University of Washington at 1 site in United States.
Trial summary
This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overdose Antidote
- What is being tested?
- Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 5 Apr 2021
- Phase
- Early 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male/female volunteers
- >18 years
- No allergy to naloxone or ingredients in its formulation
- Ability to read and understand English
- Written informed consent obtained from subject
- Ability to comply with study requirements
Who cannot join
- History of alcohol or substance abuse
- History of unusual pain sensitivity, lack of sensitivity
- History of chronic myofascial, inflammatory, neuropathic pain
- Chronic use of medication known to interfere with naloxone
- Pregnant women and nursing mothers
- Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise subject safety or the quality of the data (e.g., persons with liver disease, renal insufficiency/failure)
- Alcohol on the breath
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Naloxone Administration Via Auto-injection in Healthy Volunteers
This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.
- Conditions
- Overdose Antidote
- Being tested
- Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing systemCombination product
1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Experimental | Healthy adults will receive 1.2 mg of naloxone hydrochloride injection solution, administered once via a wearable auto-injector, West Pharma SmartDose Generation I system. The respiratory sensing system under study is used to detect slowed breathing for the purpose of triggering the administration of the naloxone. Receives: Combination Product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of slowed breathing that triggers the successful actuation of the auto-injector
Ability of the accelerometer-based system to detect slowed breathing and trigger the successful auto injection of medication
Measured: The participant breathes to 8 breaths per minute and the breath hold (15 - 30 seconds) triggers the auto-injector. This will take place over 1 -3 minutes.
Plasma concentration of naloxone in blood samples
The concentration of naloxone in the plasma is measured by blood at two time points
Measured: Blood sampling at 3 and 8 minutes after the auto injector is triggered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start10 Mar 2021
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overdose AntidoteStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Principal investigator, Jacob Sunshine, University of Washington
- Investigators
- Jacob Sunshine, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099614
- Sponsor's protocol ID
- STUDY00005944
- Other IDs
- 1914873
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naloxone Administration Via Auto-injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05099614
- Acronym / sponsor ID
- STUDY00005944
- Conditions
- Overdose Antidote
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 29 Oct 2021 (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.
This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | Experimental | Combination Product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing systemHealthy adults will receive 1.2 mg of naloxone hydrochloride injection solution, administered once via a wearable auto-injector, West Pharma SmartDose Generation I system. The respiratory sensing system under study is used to detect slowed breathing for the purpose of triggering the administration of the naloxone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male/female volunteers
- >18 years
- No allergy to naloxone or ingredients in its formulation
- Ability to read and understand English
- Written informed consent obtained from subject
Key exclusion criteria (7 listed)
- History of alcohol or substance abuse
- History of unusual pain sensitivity, lack of sensitivity
- History of chronic myofascial, inflammatory, neuropathic pain
- Chronic use of medication known to interfere with naloxone
- Pregnant women and nursing mothers
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 hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system. | Combination product | Healthy adults |
Primary outcome
Detection of slowed breathing that triggers the successful actuation of the auto-injector
Time frame: The participant breathes to 8 breaths per minute and the breath hold (15 - 30 seconds) triggers the auto-injector. This will take place over 1 -3 minutes.
Ability of the accelerometer-based system to detect slowed breathing and trigger the successful auto injection of medication
Plasma concentration of naloxone in blood samples
Time frame: Blood sampling at 3 and 8 minutes after the auto injector is triggered
The concentration of naloxone in the plasma is measured by blood at two time points
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 29 Oct 2021.
- 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.
Jacob Sunshine, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system in people with Overdose Antidote, run by University of Washington 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 6 inclusion and 7 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 29 Oct 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Detection of slowed breathing that triggers the successful actuation of the auto-injector (time frame: The participant breathes to 8 breaths per minute and the breath hold (15 - 30 seconds) triggers the auto-injector. This will take place over 1 -3 minutes.). The study lists 2 primary outcomes in all. 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 29 Oct 2021.