NCT04530591

User Acceptability of a Device-Based Opioid Overdose Intervention

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 97 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Overdose
• Opioid-use Disorder
• Substance Use Disorders

Interventions

Type	Name	Description
OTHER	Survey	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.
OTHER	Interview	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.

Timeline

• Start date: 2020-08-25
• Primary completion: 2020-09-15
• Completion: 2020-09-15
• First posted: 2020-08-28
• Last updated: 2021-07-07
• Results posted: 2021-07-07

Locations

1 site across 1 country: United States