- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305497
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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
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:
- Younger than 18
- 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
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
Collaborators
Investigators
- 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
- 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 Jan;25(1):157-65. doi: 10.1016/j.drugpo.2013.07.003. Epub 2013 Aug 9.
- 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 10.
- 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.
- Lankenau SE, Walley A. Opioids and deaths. N Engl J Med. 2011 Feb 17;364(7):686. doi: 10.1056/NEJMc1014490. No abstract available.
- 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: 10.3109/10826084.2012.720335. Epub 2012 Sep 19.
- Schwartz DG, Ataiants J, Roth A, Marcu G, Yahav I, Cocchiaro B, Khalemsky M, Lankenau S. Layperson reversal of opioid overdose supported by smartphone alert: A prospective observational cohort study. EClinicalMedicine. 2020 Aug 3;25:100474. doi: 10.1016/j.eclinm.2020.100474. eCollection 2020 Aug.
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)
October 23, 2018
Primary Completion (Actual)
May 31, 2020
Study Completion (Actual)
May 31, 2021
Study Registration Dates
First Submitted
October 4, 2017
First Submitted That Met QC Criteria
October 4, 2017
First Posted (Actual)
October 10, 2017
Study Record Updates
Last Update Posted (Actual)
September 22, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID 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.
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