User Acceptability of a Device-Based Opioid Overdose Intervention

NCT ID: NCT04530591

Last Updated: 2021-07-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-25

Study Completion Date

2020-09-15

Brief Summary

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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

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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

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Opioid Overdose Opioid-use Disorder Substance Use Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient Participants

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.

Survey

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Brenner, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Prevention Point Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Kanter K, Gallagher R, Eweje F, Lee A, Gordon D, Landy S, Gasior J, Soto-Calderon H, Cronholm PF, Cocchiaro B, Weimer J, Roth A, Lankenau S, Brenner J. Willingness to use a wearable device capable of detecting and reversing overdose among people who use opioids in Philadelphia. Harm Reduct J. 2021 Jul 23;18(1):75. doi: 10.1186/s12954-021-00522-3.

Reference Type DERIVED
PMID: 34301246 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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834304

Identifier Type: -

Identifier Source: org_study_id

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