Naloxone Auto-injection in Healthy Volunteers

Naloxone Administration Via Auto-injection in Healthy Volunteers

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 Overview

• Status: Completed
• Conditions: Overdose Antidote
• Intervention / Treatment: Combination product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Healthy adults; 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.	Combination product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system; 1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Blood sampling at 3 and 8 minutes after the auto injector is triggered

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: U.S. National Science Foundation
• Investigators: Principal Investigator: Jacob Sunshine, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2021
• Primary Completion (ACTUAL): April 5, 2021
• Study Completion (ACTUAL): April 5, 2021

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (ACTUAL): October 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Drug Overdose; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: STUDY00005944; 1914873 (OTHER_GRANT: NSF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No