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Naloxone Auto-injection in Healthy Volunteers

Primary Purpose

Overdose Antidote

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Overdose Antidote

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy adults

Arm 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.

Outcomes

Primary Outcome Measures

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

Plasma concentration of naloxone in blood samples

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05099614

First Posted

October 19, 2021

Last Updated

October 28, 2021

Sponsor

University of Washington

Collaborators

U.S. National Science Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05099614

Brief Title

Naloxone Auto-injection in Healthy Volunteers

Official Title

Naloxone Administration Via Auto-injection in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

March 10, 2021 (Actual)

Primary Completion Date

April 5, 2021 (Actual)

Study Completion Date

April 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

U.S. National Science Foundation

4. Oversight

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.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overdose Antidote

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy adults

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Title

Plasma concentration of naloxone in blood samples

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacob Sunshine, MD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Naloxone Auto-injection in Healthy Volunteers

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