User Acceptability of a Device-Based Opioid Overdose Intervention

Completed

• Conditions: Substance Use Disorders; Opioid Overdose; Opioid-use Disorder
• Interventions: Other: Survey; Other: Interview

• Registration Number: NCT04530591
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study Start: 2020-08-25
• Study First Posted: 2020-08-28
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2021-06
• Results First Submitted: 2021-06-14
• Results First Submitted QC: 2021-06-14
• Last Update Submitted: 2021-06-14
• Results First Posted: 2021-07-07
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Read More

Exclusion Criteria

• Pregnancy

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Participants	Interview	This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device.
Patient Participants	Survey	This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device.

Primary Outcome Measures

Name	Time	Method
Community Need for a Device-based Opioid Overdose Intervention	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 Outcome Measures

Name	Time	Method
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention	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.

Trial Locations

Locations (1)

Prevention Point Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States