NCT04530591

User Acceptability of a Device-Based Opioid Overdose Intervention

Completed Results posted Last updated 7 July 2021

What this trial tests

trial testing Survey in Opioid Overdose in 97 participants. Completed in 15 September 2020.

Timeline

25 August 2020

Primary endpoint
15 September 2020

15 September 2020

Quick facts

Lead sponsor	University of Pennsylvania
Status	Completed
Study type	OBSERVATIONAL
Enrollment	97
Start date	25 August 2020
Primary completion	15 September 2020
Estimated completion	15 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Survey
• Interview

Conditions studied

• Opioid Overdose — all drugs for Opioid Overdose →
• Opioid-use Disorder — all drugs for Opioid-use Disorder →
• Substance Use Disorders — all drugs for Substance Use Disorders →

Sponsor

University of Pennsylvania

Who can join

21 and older, any sex, with Opioid Overdose or Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Community Need for a Device-based Opioid Overdose Intervention Primary · 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.

Group	Value	95% CI
Patient Participants	69
Patient Participants	22

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

Likely to use a device that senses an overdose

Group	Value	95% CI
Patient Participants	70
Patient Participants	26

Likely to use a device that indicates the wearer is at risk of an overdose

Group	Value	95% CI
Patient Participants	66
Patient Participants	29

Likely to use a device that straps naloxone to the body for a bystander to administer

Group	Value	95% CI
Patient Participants	52
Patient Participants	44

Likely to use a device that senses an overdose and administers naloxone if needed

Group	Value	95% CI
Patient Participants	64
Patient Participants	32

Likely to use a device that alerts medical first responders if needed

Group	Value	95% CI
Patient Participants	68
Patient Participants	28

Likely to use a device that alerts bystanders if needed

Group	Value	95% CI
Patient Participants	60
Patient Participants	35

Likely to use a device that monitors vital signs

Group	Value	95% CI
Patient Participants	73
Patient Participants	22

For a device that sense overdose - likely to wear a necklace

Group	Value	95% CI
Patient Participants	48
Patient Participants	46

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Willingness to use a wearable device capable of detecting and reversing overdose among people who use opioids in Philadelphia.
   Kanter K, Gallagher R, Eweje F, Lee A, et al · · 2021 · cited 22× · PMID 34301246 · DOI 10.1186/s12954-021-00522-3
2. Willingness to Use a Wearable Device Capable of Detecting and Reversing Overdose Among People Who Use Opioids in Philadelphia
   Kanter K, Gallagher R, Eweje F, Lee A, et al · · 2021 · DOI 10.21203/rs.3.rs-151919/v1