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Piloting a Naloxone Intervention in Philadelphia

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ClinicalTrials.gov Identifier: NCT03305497
Recruitment Status : Completed
First Posted : October 10, 2017
Last Update Posted : September 22, 2021
Sponsor:
Collaborator:
Bar-Ilan University, Israel
Information provided by (Responsible Party):
Drexel University

Brief Summary:
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.

Condition or disease Intervention/treatment
Opioids; Harmful Use Behavioral: Mobile Phone Application

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.

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Piloting a Naloxone Intervention in an Emergency Response Community to Reduce Opioid Overdoes in Philadelphia
Actual Study Start Date : October 23, 2018
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Mobile Phone Application
    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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305497


Locations
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United States, Pennsylvania
Kensington
Philadelphia, Pennsylvania, United States, 19134
Sponsors and Collaborators
Drexel University
Bar-Ilan University, Israel
Investigators
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Principal Investigator: Stephen Lankenau, PhD Drexel University
  Study Documents (Full-Text)

Documents provided by Drexel University:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03305497    
Other Study ID Numbers: 1705005398
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Drexel University:
Opioid Overdose; Naloxone