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Clinical Trials/NCT04530591
NCT04530591
Completed
Not Applicable

A Proof of Concept, Randomized, Single Center Study on Frameworks for Wearable Devices to Sense and Respond to Opioid Overdoses

University of Pennsylvania1 site in 1 country97 target enrollmentAugust 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Overdose
Sponsor
University of Pennsylvania
Enrollment
97
Locations
1
Primary Endpoint
Community Need for a Device-based Opioid Overdose Intervention
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. The results of this one-time short questionnaire will inform development of a novel naloxone delivery device.

Detailed Description

All opioid overdose related deaths can be prevented with the timely delivery of Naloxone. This study is a one-time, preliminary survey of participants with opioid use disorder to assess the need for, and community attitudes towards, a wearable device capable of autonomously detecting and responding to an opioid overdose. The results of this survey will be used to guide ongoing development of a de novo device. This study will be conducted over a 3 month period and survey participants from the Kensington Neighborhood in North Philadelphia.

Registry
clinicaltrials.gov
Start Date
August 25, 2020
End Date
September 15, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Have used opioids for more than 3 months or will be having surgery where opioids will be administered
  • Able to provide informed consent
  • Moderate to severe chronic pain treated with opioids or recreational use

Exclusion Criteria

  • Pregnancy

Outcomes

Primary Outcomes

Community Need for a Device-based Opioid Overdose Intervention

Time Frame: Day 1

We aim to characterize the degree of need for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview.

Secondary Outcomes

  • Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention(Day 1)

Study Sites (1)

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