An interventional study of Syringe and needle and Intranasal mucosal atomization device in Drug Overdose, sponsored by State University of New York - Upstate Medical University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-08.
Sponsored by State University of New York - Upstate Medical University · Not applicable, Interventional, and Other
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.
Objectives:
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:
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.
Exclusion Criteria:
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.
Device: Syringe and needle
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.
Device: Intranasal mucosal atomization device
Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin.
Device: Nasal spray
Intramuscular administration of simulated naloxone
Intranasal atomizer administration of simulated naloxone
Nasal spray administration of simulated naloxone
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.
Time frame: 10 minutes
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.
Time frame: 10 minutes
| Milestone | Intramuscular Administration | Intranasal (Atomizer) | Intranasal (Spray) |
|---|---|---|---|
| Started | 46 | 46 | 46 |
| Completed | 46 | 46 | 46 |
| Not completed | 0 | 0 | 0 |
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.
| Participants | Intramuscular Administration | Intranasal (Atomizer) | Intranasal (Spray) |
|---|---|---|---|
| Successful Administration of Naloxone | 32 | 41 | 46 |
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.
| Seconds | Intramuscular Administration | Intranasal (Atomizer) | Intranasal (Spray) |
|---|---|---|---|
| Time to Successful Administration of Naloxone | 99.9 (50 to 420) | 110.3 (68.3 to 288.9) | 34.3 (16.3 to 59.7) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intramuscular Administration | — | 0/46 (0%) | 0/46 (0%) |
| Intranasal (Atomizer) | — | 0/46 (0%) | 0/46 (0%) |
| Intranasal (Spray) | — | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(Years) | Intramuscular Administration | Intranasal (Atomizer) | Intranasal (Spray) | Total |
|---|---|---|---|---|
| Median | 53 (18 to 77) | 51.5 (22 to 81) | 51 (18 to 79) | 52 (18 to 81) |
| Sex: Female, Male(Participants) | Intramuscular Administration | Intranasal (Atomizer) | Intranasal (Spray) | Total |
|---|---|---|---|---|
| Female | 39 | 37 | 33 | 109 |
| Male | 7 | 9 | 13 | 29 |
| Region of Enrollment(participants) | Intramuscular Administration | Intranasal (Atomizer) | Intranasal (Spray) | Total |
|---|---|---|---|---|
| United States | 46 | 46 | 46 | 138 |
| Right Handedness(Participants) | Intramuscular Administration | Intranasal (Atomizer) | Intranasal (Spray) | Total |
|---|---|---|---|---|
| Count of participants | 39 | 40 | 44 | 123 |
| College Degree(Participants) | Intramuscular Administration | Intranasal (Atomizer) | Intranasal (Spray) | Total |
|---|---|---|---|---|
| Count of participants | 21 | 12 | 21 | 54 |
No study locations are listed for this record.
Plan to share: No
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State University of New York - Upstate Medical University