Naloxone Auto-injection in Healthy Volunteers

Early Phase 1

Completed

• Conditions: Overdose Antidote

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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