Piloting a Naloxone Intervention in Philadelphia

Opioids; Harmful Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305497
• Other study ID #: 1705005398
• Status: Completed
• Start date: October 23, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioids; Harmful Use

Intervention

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.

Locations

Country	Name	City	State
United States	Kensington	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	Bar-Ilan University, Israel

Country where clinical trial is conducted

United States, 

References & Publications (5)

Lankenau SE, Wagner KD, Silva K, Kecojevic A, Iverson E, McNeely M, Kral AH. Injection drug users trained by overdose prevention programs: responses to witnessed overdoses. J Community Health. 2013 Feb;38(1):133-41. doi: 10.1007/s10900-012-9591-7. — View Citation

Lankenau SE, Walley A. Opioids and deaths. N Engl J Med. 2011 Feb 17;364(7):686. doi: 10.1056/NEJMc1014490. — View Citation

Silva K, Schrager SM, Kecojevic A, Lankenau SE. Factors associated with history of non-fatal overdose among young nonmedical users of prescription drugs. Drug Alcohol Depend. 2013 Feb 1;128(1-2):104-10. doi: 10.1016/j.drugalcdep.2012.08.014. Epub 2012 Sep — View Citation

Wagner KD, Davidson PJ, Iverson E, Washburn R, Burke E, Kral AH, McNeeley M, Jackson Bloom J, Lankenau SE. "I felt like a superhero": the experience of responding to drug overdose among individuals trained in overdose prevention. Int J Drug Policy. 2014 J — View Citation

Wagner KD, Iverson E, Wong CF, Bloom JJ, McNeeley M, Davidson PJ, McCarty C, Kral AH, Lankenau SE. Personal social network factors associated with overdose prevention training participation. Subst Use Misuse. 2013 Jan;48(1-2):21-30. doi: 10.3109/10826084. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of mobile phone app	Will persons equipped with the mobile phone app signal overdoses and/or respond to overdoses when signaled.	One year