# Predicting medical consequences of novel fentanyl analog overdose using the Toxicology Investigators Consortium (TOXIC)

> **NIH NIH R01** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2020 · $149,395

## Abstract

ABSTRACT AND PROJECT SUMMARY
The purpose of this R01 proposal is to deepen our knowledge of the primary cause of drug overdose deaths in
the U.S. today: novel psychoactive synthetic opioids, the majority of which are fentanyl analogues. Using a
multicenter network, patients who present to emergency departments with novel fentanyl analogue overdose
will be studied in terms of analytical confirmation, clinical risk factors, treatment needs, and regional trends.
The PI has assembled a multidisciplinary team with an extensive track record of collaboration in the field.
 The scope of the U.S. opioid epidemic is broadening, with drug overdose deaths nearly tripling from
1999-2015. For the first time ever, in 2015 U.S. drug overdose deaths surpassed 50,000 (52,404), of which
33,091 (63.1%) involved an opioid. Overdose deaths continued to increase in 2016 to 63,600. Opioid
overdoses cost Americans $504 billion in 2015 (2.8% of gross domestic product), up from six times the prior
estimates in 2013. There was a 27% increase in nationwide Emergency Department visits for opioid overdoses
last year alone. Strategies to mitigate this trend by decreasing the availability and abuse potential of
prescription opioids have been followed by an increase in illicit opioid use. While initially the predominance of
illicit opioid overdoses were a result of heroin exposure, the changing face of global drug commerce introduced
synthetic opioid fentanyl analogues into the drug supply, where they are now estimated to have surpassed
heroin as the primary cause of drug overdose deaths.
 Using nearly 70 hospital centers nationwide with bedside evaluation of patients, over 10,000 overdose
patients have been enrolled in the Principal Investigator’s prior study giving this proposal momentum and
feasibility.
 Our specific aims are three-fold: (1) To confirm and characterize fentanyl analogue overdoses in a new
prospective cohort; (2) To evaluate sequelae, treatment needs, and resource utilization following fentanyl
analogue overdoses; and (3) To trend and geolocate analytically confirmed fentanyl analogue overdoses
across a multicenter network.
 To achieve these Specific Aims, we will prospectively enroll a new multicenter cohort of patients. We
will implement the rapid dissemination of alerts and information to the public and public health entities on
adverse effects of fentanyl analogues. At the completion of the proposed research, the field of drug abuse will
be significantly advanced to allow prediction of medical consequences for thousands of victims of the U.S.
opioid epidemic.

## Key facts

- **NIH application ID:** 10160611
- **Project number:** 3R01DA048009-01A1S1
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Alex Francis Manini
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $149,395
- **Award type:** 3
- **Project period:** 2020-04-01 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10160611

## Citation

> US National Institutes of Health, RePORTER application 10160611, Predicting medical consequences of novel fentanyl analog overdose using the Toxicology Investigators Consortium (TOXIC) (3R01DA048009-01A1S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10160611. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*