Drug OverdoseNCT03309449
A Usability Assessment of Naloxone by Community Members
A study testing Syringe and needle, Intranasal mucosal atomization device and Nasal spray in people with Drug Overdose, run by State University of New York - Upstate Medical University.
Trial summary
This will be a usability trial to assess administration of naloxone via intramuscular, atomized intranasal, and nasal spray routes by nonmedical community members. Participants will undergo blocked randomization to naloxone kits containing supplies for one of the aforementioned routes and view an instructional video… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Overdose
- What is being tested?
- Syringe and needle, Intranasal mucosal atomization device and Nasal spray
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 adults at least 18 years of age
Who cannot join
- severely visually or hearing impaired (defined as: legally deaf, legally blind, unable to read print size provided on instructional handout, or unable to hear video audio), previous naloxone administration training, not English proficient, previously participated in the trial, or pregnant
About this study
Official title: A Usability Assessment of Intramuscular, Atomized Intranasal, and Nasal Spray Administration of Naloxone by Community Members
This will be a usability trial to assess administration of naloxone via intramuscular, atomized intranasal, and nasal spray routes by nonmedical community members. Participants will undergo blocked randomization to naloxone kits containing supplies for one of the aforementioned routes and view an instructional video on how to appropriately administer the kit they were assigned. Participants will then have the opportunity to administer the simulated drug to a mannequin designated to simulate the route of administration assigned to the participant. The rate of successful administration will be determined for each route.
Read the detailed description
Objectives:
- Primary: The successful administration of simulated naloxone. A successful administration will be defined as administration of the simulated naloxone to the mannequin head or simulated flesh pad within 10 minutes and without any critical errors (defined below).
- Secondary: Total time required to successfully administer the simulated naloxone.
Design: Single site, open-label, randomized usability assessment of intramuscular, intranasal, and nasal spray administration of simulated naloxone. A convenience sample of participants will consent to volunteer in the study at a public venue. Participants will provide verbal consent and will be randomly assigned a simulated naloxone kit containing either intramuscular, intranasal, or nasal spray administration materials. Participants will be shown an instructional video demonstrating how to appropriately assemble and administer the simulated naloxone kit they were randomly assigned. Once the video is complete the individual will enter a use scenario station where they will be asked to assemble and administer the simulated naloxone kit to a mannequin (intranasal and nasal spray) or simulated flesh pad (intramuscular). The participant will be instructed to start and will be timed until the simulated naloxone has been successfully administered or 10 minutes has elapsed. The participant will be observed by one trained investigator who will assess for successful administration of the simulated naloxone and critical errors. The environment will contain distractors (radio playing) and items that will simulate a community based dwelling (table, chairs, and an inflatable mattress). The mannequin and simulated flesh pad will be located on the mattress. Once the participant has successfully administered simulated naloxone or 10 minutes elapses the timer will be stopped. Successful administration of simulated naloxone will be defined as administration of the agent without any critical errors occurring (defined below). Data collected will include demographics (defined below), successful administration of simulated naloxone, and time to successful administration of simulated naloxone.
Statistical Methods: All data will be analyzed using IBM SPSS Statistics software. Demographics data will be analyzed using descriptive statistics for continuous measures and percentages for categorical measures. The successful administration of naloxone will be compared between groups using the Chi-square test and a significant difference will be defined as a p-value of less than 0.05 for the result. The time to administration between groups will be assessed using a one-way ANOVA and a significant difference will be defined as a p-value of less than 0.05 for the result.
Data Analysis/Interpretation: As stated above data will be collected to assess both the successful administration of and time to administration of naloxone. The rate of successful administration will be reported as a percentage for each of the three groups and analyzed using the Chi-square test. Successful administration is defined as administration of the simulated naloxone within 10 minutes without committing any critical errors. Critical errors are as follows:
- Intranasal (atomizer): failure to remove both yellow caps from bristoject, failure to remove cap from simulated naloxone, failure to attach atomizer, failure to attach simulated naloxone, drug leak prior to administration, administration in only one nostril, and failure to administer within 10 minutes.
- Intramuscular: failure to attach the needle to the syringe, failure to remove cap from simulated naloxone, failure to draw up >90% (0.9 mL) of the simulated naloxone, failure to puncture simulated flesh pad with needle, failure to push entire volume of fluid in the syringe into the simulated flesh pad, and failure to administer within 10 minutes.
- Intranasal (spray): failure to place the tip of the device into one nostril, failure to depress the device and release the simulated naloxone, failure to administer within 10 minutes.
Time to successful administration will be reported using descriptive statistics (mean time to administration) and analyzed using a one-way ANOVA. Times for participants who commit a critical error or who do no administer the simulated naloxone within 10 minutes will not be included in the analysis.
A route of administration will be considered to be more user-friendly if it demonstrates a statistically significantly higher rate of successful administration compared to another route of administration.
Study Procedures: No study procedures will be performed on study participants.
- Conditions
- Drug Overdose
- Being tested
- Syringe and needle, Intranasal mucosal atomization device, Nasal spray
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syringe and needleDevice
Intramuscular administration of simulated naloxone
Intranasal mucosal atomization deviceDevice
Intranasal atomizer administration of simulated naloxone
Nasal sprayDevice
Nasal spray administration of simulated naloxone
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular administration | Other | Participants in this arm will be provided with the training and supplies to administer intramuscular simulated naloxone using a syringe and needle to a simulated flesh pad on a mannequin. Receives: Device: Syringe and needle |
| Intranasal (Atomizer) | Other | Participants in this arm will be provided with the training and supplies to administer atomized intranasal simulated naloxone to a mannequin via a syringe using an intranasal mucosal atomization device. Receives: Device: Intranasal mucosal atomization device |
| Intranasal (Spray) | Other | Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin. Receives: Device: Nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Administration of Naloxone
A successful administration will be defined as administration of the simulated naloxone to the mannequin head or simulated flesh pad within 10 minutes and without any critical errors. Critical errors include: Failure to attach the needle to the syringe, failure to place the device tip into a nostril, failure to remove both caps from the device, failure to remove the cap from the naloxone, failure to depress the device and release the naloxone into the nostril, failure to remove cap from the naloxone, failure to draw up > 90% (0.9 ml) of the naloxone, failure to attach atomizer to the device, failure to puncture the simulated flesh pad with the needle, failure to attach the naloxone to the device, failure to push the naloxone into the simulated flesh pad, drug leakage before administration, and administration of the total volume in a single nostril.
Measured: 10 minutes
Secondary outcomes (1)
Time to Successful Administration of Naloxone
The time required to successfully administer the simulated naloxone will be reported for each group. Only participants who were successful administering naloxone were included in this analysis.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study startAug 2016
- Primary completionSep 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Eggleston, PharmD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309449
- Sponsor's protocol ID
- 922070-1
- Status last verified
- Jun 2023
- First submitted
- 11 Jul 2016
- Last updated
- 8 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Usability Assessment of Intramuscular, Atomized Intranasal, and Nasal Spray Administration of Naloxone by Community Members
- ClinicalTrials.gov ID
- NCT03309449
- Acronym / sponsor ID
- 922070-1
- Conditions
- Drug Overdose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a usability trial to assess administration of naloxone via intramuscular, atomized intranasal, and nasal spray routes by nonmedical community members. Participants will undergo blocked randomization to naloxone kits containing supplies for one of the aforementioned routes and view an instructional video on how to appropriately administer the kit they were assigned. Participants will then have the opportunity to administer the simulated drug to a mannequin designated to simulate the route of administration assigned to the participant. The rate of successful administration will be determined for each route.
Detailed description
Objectives:
- Primary: The successful administration of simulated naloxone. A successful administration will be defined as administration of the simulated naloxone to the mannequin head or simulated flesh pad within 10 minutes and without any critical errors (defined below).
- Secondary: Total time required to successfully administer the simulated naloxone.
Design: Single site, open-label, randomized usability assessment of intramuscular, intranasal, and nasal spray administration of simulated naloxone. A convenience sample of participants will consent to volunteer in the study at a public venue. Participants will provide verbal consent and will be randomly assigned a simulated naloxone kit containing either intramuscular, intranasal, or nasal spray administration materials. Participants will be shown an instructional video demonstrating how to appropriately assemble and administer the simulated naloxone kit they were randomly assigned. Once the video is complete the individual will enter a use scenario station where they will be asked to assemble and administer the simulated naloxone kit to a mannequin (intranasal and nasal spray) or simulated flesh pad (intramuscular). The participant will be instructed to start and will be timed until the simulated naloxone has been successfully administered or 10 minutes has elapsed. The participant will be observed by one trained investigator who will assess for successful administration of the simulated naloxone and critical errors. The environment will contain distractors (radio playing) and items that will simulate a community based dwelling (table, chairs, and an inflatable mattress). The mannequin and simulated flesh pad will be located on the mattress. Once the participant has successfully administered simulated naloxone or 10 minutes elapses the timer will be stopped. Successful administration of simulated naloxone will be defined as administration of the agent without any critical errors occurring (defined below). Data collected will include demographics (defined below), successful administration of simulated naloxone, and time to successful administration of simulated naloxone.
Statistical Methods: All data will be analyzed using IBM SPSS Statistics software. Demographics data will be analyzed using descriptive statistics for continuous measures and percentages for categorical measures. The successful administration of naloxone will be compared between groups using the Chi-square test and a significant difference will be defined as a p-value of less than 0.05 for the result. The time to administration between groups will be assessed using a one-way ANOVA and a significant difference will be defined as a p-value of less than 0.05 for the result.
Data Analysis/Interpretation: As stated above data will be collected to assess both the successful administration of and time to administration of naloxone. The rate of successful administration will be reported as a percentage for each of the three groups and analyzed using the Chi-square test. Successful administration is defined as administration of the simulated naloxone within 10 minutes without committing any critical errors. Critical errors are as follows:
- Intranasal (atomizer): failure to remove both yellow caps from bristoject, failure to remove cap from simulated naloxone, failure to attach atomizer, failure to attach simulated naloxone, drug leak prior to administration, administration in only one nostril, and failure to administer within 10 minutes.
- Intramuscular: failure to attach the needle to the syringe, failure to remove cap from simulated naloxone, failure to draw up >90% (0.9 mL) of the simulated naloxone, failure to puncture simulated flesh pad with needle, failure to push entire volume of fluid in the syringe into the simulated flesh pad, and failure to administer within 10 minutes.
- Intranasal (spray): failure to place the tip of the device into one nostril, failure to depress the device and release the simulated naloxone, failure to administer within 10 minutes.
Time to successful administration will be reported using descriptive statistics (mean time to administration) and analyzed using a one-way ANOVA. Times for participants who commit a critical error or who do no administer the simulated naloxone within 10 minutes will not be included in the analysis.
A route of administration will be considered to be more user-friendly if it demonstrates a statistically significantly higher rate of successful administration compared to another route of administration.
Study Procedures: No study procedures will be performed on study participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intramuscular administration | Other | Device: Syringe and needleParticipants in this arm will be provided with the training and supplies to administer intramuscular simulated naloxone using a syringe and needle to a simulated flesh pad on a mannequin. |
| Intranasal (Atomizer) | Other | Device: Intranasal mucosal atomization deviceParticipants in this arm will be provided with the training and supplies to administer atomized intranasal simulated naloxone to a mannequin via a syringe using an intranasal mucosal atomization device. |
| Intranasal (Spray) | Other | Device: Nasal sprayParticipants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults at least 18 years of age
Key exclusion criteria (1 listed)
- severely visually or hearing impaired (defined as: legally deaf, legally blind, unable to read print size provided on instructional handout, or unable to hear video audio), previous naloxone administration training, not English proficient, previously participated in the trial, or pregnant
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 |
|---|---|---|
| Syringe and needleIntramuscular administration of simulated naloxone | Device | Intramuscular administration |
| Intranasal mucosal atomization deviceIntranasal atomizer administration of simulated naloxone | Device | Intranasal (Atomizer) |
| Nasal sprayNasal spray administration of simulated naloxone | Device | Intranasal (Spray) |
Primary outcome
Successful Administration of Naloxone
Time frame: 10 minutes
A successful administration will be defined as administration of the simulated naloxone to the mannequin head or simulated flesh pad within 10 minutes and without any critical errors. Critical errors include: Failure to attach the needle to the syringe, failure to place the device tip into a nostril, failure to remove both caps from the device, failure to remove the cap from the naloxone, failure to depress the device and release the naloxone into the nostril, failure to remove cap from the naloxone, failure to draw up > 90% (0.9 ml) of the naloxone, failure to attach atomizer to the device, failure to puncture the simulated flesh pad with the needle, failure to attach the naloxone to the device, failure to push the naloxone into the simulated flesh pad, drug leakage before administration, and administration of the total volume in a single nostril.
1 secondary outcome
Time to Successful Administration of Naloxone
Time frame: 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
William Eggleston, PharmD principal investigator
State University of New York - Upstate Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Syringe and needle, Intranasal mucosal atomization device and Nasal spray in people with Drug Overdose, run by State University of New York - Upstate Medical University.
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 1 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 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Administration of Naloxone (time frame: 10 minutes). 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 8 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.