Opioid OverdoseNCT04530591

User Acceptability of a Device-Based Opioid Overdose Intervention

An observational study of Opioid Overdose and Opioid-use Disorder, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Opioid Overdose, Opioid-use Disorder, Substance Use Disorders
What is being tested?: Survey and Interview
How many people: 97 participants
Where: 1 siteUnited States
Study dates: 25 Aug 2020to 15 Sep 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Study population is non-pregnant individuals over the age of 21 with opioid use disorder.

Who may be able to join

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

Who cannot join

Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Prevention Point Philadelphia
Philadelphia, Pennsylvania, 19134

Other trials in United States

About this study

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

Read the 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
Being tested: Survey, Interview
Keywords: Naloxone Delivery, Survey
Medical subject headings: Opiate Overdose, Opioid-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurveyOther
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.
InterviewOther
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.

Study groups in NCT04530591
Study group	Role	What they receive
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. Receives: Other: Survey; Other: Interview

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1

Secondary outcomes (1)

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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 202015 Sep 2020

First posted28 Aug 2020
Study start25 Aug 2020
Primary completion15 Sep 2020
Study completion15 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid OverdoseStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04530591
Sponsor's protocol ID: 834304
Status last verified: Jun 2021
First submitted: 24 Aug 2020
Last updated: 7 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34301246

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)
Not yet recruiting
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Opioid Overdose (Trial 3 of 3)
Remote vs. In-Person, Remote Visits
Recruiting
The ENHANCE Project Toolkit
Substance Related Disorder, Drug Overdose

All Opioid Overdose trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Concept, Randomized, Single Center Study on Frameworks for Wearable Devices to Sense and Respond to Opioid Overdoses
ClinicalTrials.gov ID: NCT04530591
Acronym / sponsor ID: 834304
Conditions: Opioid Overdose, Opioid-use Disorder, Substance Use Disorders
Keywords: Naloxone Delivery, Survey
Study type: Observational
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 25 Aug 2020 (actual)
Primary completion: 15 Sep 2020 (actual)
Study completion: 15 Sep 2020 (actual)
First posted: 28 Aug 2020 (actual)
Results: Posted 7 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patient Participants	–	Other: Survey, Other: InterviewThis 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Study population is non-pregnant individuals over the age of 21 with opioid use disorder.

Key inclusion criteria (3 listed)

Have used opioids for more than 3 months or will be having surgery where opioids will be administered

Key exclusion criteria (1 listed)

Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SurveyParticipants 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	Patient Participants
InterviewParticipants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device.	Other	Patient Participants

Primary outcome

Community Need for a Device-based Opioid Overdose Intervention
Time frame: 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.

1 secondary outcome

Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Time frame: Day 1

Results and safety

Results posted to the registry on 7 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient Participants	97	97

Primary outcome: Community Need for a Device-based Opioid Overdose Intervention

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Patient Participants n = 91
Likely	69
Unlikely	22

Population analysed: Some participants did not answer all the questions or selected more than one answer

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected at the time of survey administration (1 hour).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient Participants	0 of 0	0 of 97 (0%)	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34301246Kanter 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.
Individual participant dataSharing planned: No

Related trials for Opioid Overdose

Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)
Not yet recruiting
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Opioid Overdose (Trial 3 of 3)
Remote vs. In-Person, Remote Visits
Recruiting
The ENHANCE Project Toolkit
Substance Related Disorder, Drug Overdose

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacob Brenner, MD/PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid Overdose and Opioid-use Disorder, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Community Need for a Device-based Opioid Overdose Intervention (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04530591, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.