Skip to main content
OpenTrials
Completed

NCT Number: NCT03305497

Piloting a Naloxone Intervention 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kensington

Philadelphia, Pennsylvania, 19134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Younger than 18
  • Does not speak/read English

Treatment and study plan

Mobile Phone Application

Behavioral

110 persons will be equipped with a mobile phone application, trained in overdose prevention, and equipped with naloxone. The mobile phone app will allow persons witnessing an overdose to signal persons in the vicinity to respond with naloxone.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • Bar-Ilan University, Israel

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 10, 2017
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.