Ongoing Studies
- FDA/Toxicology Investigators’ Consortium (ToxIC) Drug Overdose Toxico-Surveillance (DOTS) Reporting Program
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In 2018, the FDA released a Strategic Policy Roadmap detailing their plan to address the misuse and abuse of opioid drugs.4,5 Exposure prevention, support treatment, and taking action against illegally or diverted opioid products has become a priority. However, we currently lack an understanding of the social determinants of overdose deaths compared to nonfatal overdoses. We also lack understanding on the evolving polysubstance use epidemic and its role in drug overdoses. To address this knowledge gap, we propose creating a sub-registry utilizing our multi-center network of sites to collect detailed clinical information on cases presenting to the ED with overdose to opioids, stimulants, and undifferentiated illicit drugs. In addition to clinical information, blood will be collected from each qualifying case and sent for comprehensive laboratory testing for over 900 psychoactive drugs and their metabolites. As part of this project, we will also gather more information through structured patient interviews including obtaining data on the product/substance type and source, and a more detailed past drug use/social history. The DOTS project is in line with the FDA’s mission to learn more about missed opportunities for prevention, effective treatment of a novel opioid overdose, and targeted interventions of those groups that are at the highest risk of being affected by this crisis.
Site Principal Investigator: Anthony Pizon, MD
- Predicting Medical Consequences of Novel Fentanyl Analog Overdose Using the Toxicology Investigators Consortium (ToxIC)
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Novel psychoactive substances (NPS) are specifically designed to mimic the actions of known abused drugs, and currently pose a major public health threat. Novel synthetic fentanyl analogues (fentalogs) tend to have euphoric and sedative properties, greater potency, and higher addictive potential than morphine. In 2016, there were 63,600 U.S. drug overdose (OD) deaths, of which 20,145 were synthetic opioids, mostly fentalogs. Opioid NPS use now drives the opioid epidemic, as deaths involving fentalogs have surpassed prescription opioids.
Current knowledge gaps regarding fentalog OD make it impossible to devise strategies or allocate resources to address the problem. While fentalogs are the greatest opioid threat to public health today, the scope of the problem, incidence, prevalence and even the culprit molecules are not known. From 2017-18, U.S. emergency departments (ED) saw a 27% increase in opioid OD visits. In one region last year, >95% of ED patients with suspected heroin OD actually tested positive for fentalogs; alarmingly, >40% of those were unable to self-identify the fentalog exposure. To date, reports of the clinical effects of fentalogs have been unreliable as most studies utilize only self-report without toxicological testing.
Finally, there currently is no standardized approach to the diagnosis or management of fentalog OD for the majority of EDs. Given these critical gaps in the understanding of fentalog OD, the PI has assembled a multidisciplinary team (emergency care, medical toxicology, forensic analytics, and drug abuse epidemiology) with the resources to rapidly accumulate prospective, multicenter, molecular and clinical data on fentalog OD by leveraging the existing Toxicology Investigators’ Consortium (ToxIC) hospital network, a multicenter partnership of 65 U.S. hospitals, all with capability for bedside medical toxicology evaluation of ED patients.
Site Principal Investigator: Joshua Shulman, MD
- Feasibility of assessing alcohol withdrawal syndrome with a wearable biosensor
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This pilot study serves both to assess the feasibility of using a wearable biosensor to assess the physiologic state of alcohol withdrawal, and to generate initial pilot data to inform future research.
Principal Investigator: Simon Ostrowski, MD
Select Completed Studies
A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting
Sharvari Shivanekar, Priya Gopala, Anthony Pizon, Crystal Spotts, Nicolas Cruz, Michael Lightfoot, Rebecca Rohac, Andrew Baumeister, Angela Griffo, Benjamin Panny, Shelly Kucherer, Alex Israel, Manivel Rengasamy, Rebecca Price | International Journal of Environmental Research and Public Health (2022)
Failure of Crotalidae Immune F(ab')2 Equine Antivenom to Achieve Control in a Southern Pacific Rattlesnake Envenomation
Michael Levnie, Hannah Spungen, Anthony Pizon | Annals of Emergency Medicine (2022)
Outcomes following Naloxone Administration by Bystanders and First Responders
Andrew Farkas, Rachael Westover, Anthony Pizon, Michael Lynch, Christian Martin-Gill | Prehospital Emergency Care (2021)
Highest reported clearance of valproate by hemodialysis in massive overdose
Alexander Sidlak, Samuel York, Adam Janicki, Anthony Pizon | American Journal of Emergency Medicine (2021)
Drug-specific risk of severe QT prolongation following acute drug overdose
Sharan Campleman, Jeffrey Brent, Anthony Pizon, Joshua Shulman, Paul Wax, Alex Manini for the Toxicology Investigators' Consortium (ToxIC) | Clinical Toxicology (2020)