Naloxone Auto-injection in Healthy Volunteers

Early Phase 1

Completed

• Conditions: Overdose Antidote
• Interventions: Combination Product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system

• Registration Number: NCT05099614
• Lead Sponsor: University of Washington

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-10
• Primary Completion: 2021-04-05
• Study Completion: 2021-04-05
• Status Verified: 2021-10
• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy adults	Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system	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.

Primary Outcome Measures

Name	Time	Method
Detection of slowed breathing that triggers the successful actuation of the auto-injector	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	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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States