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OpenTrials
Completed

NCT Number: NCT04530591

User Acceptability of a Device-Based Opioid Overdose Intervention

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.

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Key information

Conditions

Opioid Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid-Related Disorders Opioid-use Disorder Prescription Drug Misuse Substance Use Disorders Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prevention Point Philadelphia

Philadelphia, Pennsylvania, 19134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Survey

Other

Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.

interview

Other

Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device.

Primary outcomes

  1. 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

  1. Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention

    Time frame: Day 1

    We aim to characterize the functional and aesthetic preferences of the participant population 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2020
Registry last updated
Jul 7, 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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