An observational study in Opioids; Harmful Use, sponsored by Drexel University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Drexel University · Observational
Among 56 studies in Opiate Overdose with a site in United States — 8 open to participants now, 15 under way, none of them phase 3. Opiate Overdose · United States.
Among the 56 studies in Opiate Overdose with a site in United States, this one is the 6th largest by enrollment of the 12 observational ones, is one of 3 that started in 2018, is one of 12 observational ones, and was the 4th registered.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 110 is below the median of 284 across 16 observational studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →8 of the 56 studies in Opiate Overdose with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 8 Opiate Overdose studies recruiting now, 6 (75%) set no upper age limit and 2 (25%) stop at 75 or younger; 1 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →56 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2018.
Median enrollment 184 across the 44 interventional studies, 106 across the 12 observational. Of the 35 that completed or were terminated, 15 (43%) have results posted.
8 of 56 have an industry lead sponsor. The 10 most frequent:
Drexel University is the lead sponsor of 113 studies on the registry; 17 are open to participants now.
Drexel University has 2 studies filed under Opiate Overdose — fewer than ten, so there is no comparison to draw.
1 of the studies in Opiate Overdose with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05713695University of Massachusetts, WorcesterSupporting Treatment Access and Recovery Through Linkage and Support | 2026-12 |
Among the 56 studies in Opiate Overdose with a site in United States, from their registry updates:
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.
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.
55 non-medical users of opioids (NMOU) (e.g., prescription opioids, heroin) and 55 community members who know active, former, or deceased NMOU.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Use of mobile phone app
Will persons equipped with the mobile phone app signal overdoses and/or respond to overdoses when signaled.
Time frame: One year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No plan to share IPD with other researchers.
Ran from Oct 2018 to primary completion in May 2020, 19 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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