Naloxone Auto-injection in Healthy Volunteers

Early Phase 1CompletedNCT05099614

University of Washington20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Overdose Antidote

Interventions

Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing systemCOMBINATION_PRODUCT

1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Ability of the accelerometer-based system to detect slowed breathing and trigger the successful auto injection of medication

Time frame: 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.

Plasma concentration of naloxone in blood samples

The concentration of naloxone in the plasma is measured by blood at two time points

Time frame: Blood sampling at 3 and 8 minutes after the auto injector is triggered

Data from ClinicalTrials.gov

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