Trial Outcomes & Findings for A Usability Assessment of Naloxone by Community Members (NCT NCT03309449)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

138 participants

Primary outcome timeframe

10 minutes

Results posted on

2023-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Intramuscular Administration 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. Syringe and needle: Intramuscular administration of simulated naloxone	Intranasal (Atomizer) 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. Intranasal mucosal atomization device: Intranasal atomizer administration of simulated naloxone	Intranasal (Spray) Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin. Nasal spray: Nasal spray administration of simulated naloxone
Overall Study STARTED	46	46	46
Overall Study COMPLETED	46	46	46
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Usability Assessment of Naloxone by Community Members

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intramuscular Administration n=46 Participants 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. Syringe and needle: Intramuscular administration of simulated naloxone	Intranasal (Atomizer) n=46 Participants 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. Intranasal mucosal atomization device: Intranasal atomizer administration of simulated naloxone	Intranasal (Spray) n=46 Participants Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin. Nasal spray: Nasal spray administration of simulated naloxone	Total n=138 Participants Total of all reporting groups
Age, Continuous	53 Years n=5 Participants	51.5 Years n=7 Participants	51 Years n=5 Participants	52 Years n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	37 Participants n=7 Participants	33 Participants n=5 Participants	109 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	46 participants n=5 Participants	46 participants n=7 Participants	46 participants n=5 Participants	138 participants n=4 Participants
Right Handedness	39 Participants n=5 Participants	40 Participants n=7 Participants	44 Participants n=5 Participants	123 Participants n=4 Participants
College Degree	21 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants	54 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intramuscular Administration n=46 Participants 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. Syringe and needle: Intramuscular administration of simulated naloxone	Intranasal (Atomizer) n=46 Participants 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. Intranasal mucosal atomization device: Intranasal atomizer administration of simulated naloxone	Intranasal (Spray) n=46 Participants Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin. Nasal spray: Nasal spray administration of simulated naloxone
Successful Administration of Naloxone	32 Participants	41 Participants	46 Participants

SECONDARY outcome

Timeframe: 10 minutes

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.

Outcome measures

Outcome measures
Measure	Intramuscular Administration n=32 Participants 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. Syringe and needle: Intramuscular administration of simulated naloxone	Intranasal (Atomizer) n=41 Participants 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. Intranasal mucosal atomization device: Intranasal atomizer administration of simulated naloxone	Intranasal (Spray) n=46 Participants Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin. Nasal spray: Nasal spray administration of simulated naloxone
Time to Successful Administration of Naloxone	99.9 Seconds Interval 50.0 to 420.0	110.3 Seconds Interval 68.3 to 288.9	34.3 Seconds Interval 16.3 to 59.7

Adverse Events

Intramuscular Administration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intranasal (Atomizer)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intranasal (Spray)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Eggleston

SUNY Upstate Medical University

Phone: 315-464-8906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place