Naloxone Auto-injection in Healthy Volunteers

University of Washington

Status and phase: Completed; Early Phase 1

Conditions: Overdose Antidote

Treatments: Combination Product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05099614

1914873 (Other Grant/Funding Number)

STUDY00005944

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Healthy adults

Experimental group

Description:

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.

Treatment:

Combination Product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system