User Acceptability of a Device-Based Opioid Overdose Intervention

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530591
• Other study ID #: 834304
• Status: Completed
• Start date: August 25, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: June 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Drug Overdose
• Opioid Overdose
• Opioid-use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Prevention Point Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Community Need for a Device-based Opioid Overdose Intervention	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.	Day 1
Secondary	Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention	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.	Day 1