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OpenTrials
Completed

NCT Number: NCT05099614

Naloxone 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.

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Key information

Conditions

Overdose Antidote

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Combination Product

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

Primary outcomes

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

    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.

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

  2. Plasma concentration of naloxone in blood samples

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • U.S. National Science Foundation

Registry information

Official study title

Naloxone Administration Via Auto-injection in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2021
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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