Piloting a Naloxone Intervention in Philadelphia

September 20, 2021 updated by: Drexel University

Piloting a Naloxone Intervention in an Emergency Response Community to Reduce Opioid Overdoes in Philadelphia

The escalating opioid overdose epidemic is one of the most serious public health problems confronting the U.S. Death due to drug overdose is a significant and rising cause of mortality and morbidity in Philadelphia. While naloxone is increasingly accessible to combat opioid overdoses, new responses to delivering naloxone to overdose events are needed. The proposed pilot project, to be conducted in Philadelphia, will pursue three specific aims: 1) Identify barriers and facilitators of acceptance and use of a smartphone-based naloxone intervention; 2) Pilot test the implementation of the intervention among 55 non-medical opioid users and 55 community members; 3) Synthesize knowledge acquired in Aims 1 and 2 to be used in a subsequent R01 study to conduct a large-scale, multi-site implementation trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The escalating opioid overdose epidemic is one of the most serious public health problems confronting the U.S. In 2014, a record 47,055 people died from a drug overdose in the U.S., which outnumbered deaths from motor vehicle crashes by approximately one and a half times. Heroin and misuse of prescription opioids contributed to a majority of drug overdoses in 2014. Death due to drug overdose is a significant and rising cause of mortality and morbidity in Philadelphia. In 2015, almost 700 drug overdose deaths were reported in Philadelphia - twice as many as deaths from homicide. In response, health policy, legislation, and research funding are increasingly converging in support of the distribution of naloxone, an opioid antagonist, and community-based opioid overdose prevention programs (OPP). The success of OPP is contingent upon the willingness and effectiveness of bystanders to respond to an overdose event and administer naloxone. Emergency Response Communities (ERC) are specialized smartphone-based social networks in which members are approved carriers and/or potential users of a specific medication, such as naloxone. The ERC approach is ideally suited to support, facilitate, and encourage naloxone administration in opioid overdose emergencies, but is untested to date. The model combines GPS and IP-location tracking to identify potential opioid overdose through a smartphone application or app. Towards this end, we are proposing the development and pilot testing of a smartphone app-based naxolone intervention (ERC-NAX) in an ERC in Philadelphia. Research is needed to understand the needs and barriers in communities at high-risk for opioid overdose that will enable effective design, adaption, and implementation of an ERC-NAX app. Guided by preliminary data from study investigators, the proposed pilot project will pursue three specific aims: 1) Identify barriers and facilitators of acceptance and use of a smartphone-based ERC naloxone intervention; 2) Pilot test the implementation of ERC-NAX in an ERC consisting of 55 non-medical opioid users and 55 community members; 3) Synthesize knowledge acquired in Aims 1 and 2 to be used in a subsequent R01 study to conduct a large-scale, multi-site implementation trial. This 3-year study will provide actionable evidence regarding the viability and acceptance of an app-based naloxone intervention following the ERC model. It will be developed and tested in partnership with two community partners in Philadelphia with extensive experience in overdose prevention. This proposed intervention is significant since it leverages the growing success of OPP and will empower communities at high-risk for opioid overdose to provide rapid, secure, and effective emergency response in the event of overdose. This novel intervention, which is designed to augment emergency medical services in the rapid delivery of naloxone to overdose victims, may be effective at deescalating the epidemic of opioid overdose fatalities in Philadelphia and communities elsewhere.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19134
        • Kensington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

55 non-medical users of opioids (NMOU) (e.g., prescription opioids, heroin) and 55 community members who know active, former, or deceased NMOU.

Description

Inclusion Criteria:

1. Weekly misuse of heroin and/or rx opioid during past 30 days OR knows active, former, or deceased NMOU 2. Currently lives in zip codes 19122, 19125, 19133, 19134 3. Willingness to carry naloxone 4. Owns smartphone/data package 5. 18 years old or older 6. Speaks/reads English

Exclusion Criteria:

  1. Younger than 18
  2. Does not speak/read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Use of mobile phone app
Time Frame: One year
Will persons equipped with the mobile phone app signal overdoses and/or respond to overdoses when signaled.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Drexel University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bar-Ilan University, Israel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen Lankenau, PhD, Drexel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1705005398

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioids; Harmful Use

Clinical Trials on Mobile Phone Application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings