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Principal Investigator: Alex Francis Manini
Organization: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Fiscal Year: 2024
Award: $648,054
Funding agency: National Institute on Drug Abuse
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
nationwide registry of patients who present to emergency departments, novel fentanyl analogue overdose will
be studied in terms of its epidemiology, analytical confirmation, clinical risk factors, and treatment needs, by a
uniquely qualified 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 four-fold: (1) To derive and validate clinical predictors of adverse health consequences of
fentanyl analogue overdose; (2) To confirm fentanyl analogue exposure via state-of-the-art toxicology testing;
(3) To investigate treatment utilization, duration, and disparities for fentanyl analogue overdose; and (4) To
assess epidemiology of analytically-confirmed fentanyl analogue overdose.
To achieve these Specific Aims, we will prospectively enroll a national sampling 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 the benefit of thousands of victims of the U.S. opioid epidemic.
Terms: <2-amino-1-phenyl 1-propanone><2-aminopropiophenone><Accident and Emergency department><Address><Admission><Admission activity><Adverse effects><Affect><American><Biological><Caring><Cessation of life><Characteristics><Chronology><Clinical><Clinical Data><Clinical Management><Cocaine><Collaborations><Commerce><Critical Care><Data><Death><Diacetylmorphine><Diagnosis><Diamorphine><Disease Outbreaks><Disparities><Disparity><Drug abuse><Drug usage><Drugs><ED care><ED patient><ED visit><ER care><ER patient><ER visit><Emergency Care><Emergency Department><Emergency Department care><Emergency Department evaluation><Emergency Department patient><Emergency Room care><Emergency Room patient><Emergency care visit><Emergency department visit><Emergency health care><Emergency healthcare><Emergency hospital visit><Emergency medical care><Emergency room><Emergency room visit><Enrollment><Epidemic><Epidemiology><Evaluation><Factor Analyses><Factor Analysis><Forensic Medicine><Forensics><Health><Heroin><Hospitals><Incidence><Individual><Infumorph><Ingestion><Investigators><Kadian><Knowledge><Laboratory Markers><Length of Stay><Liquid Chromatography><MS Contin><MSir><Mechanical ventilation><Medical><Medical Records><Medication><Molecular><Morphia><Morphine><NIDA><Naloxone><Narcan><Narcanti><National Institute of Drug Abuse><National Institute on Drug Abuse><Number of Days in Hospital><Opiates><Opioid><Oramorph><Oramorph SR><Outbreaks><Outcome><Overdose><Patient Self-Report><Patients><Pattern><Periodicals><Pharmaceutical Preparations><Poison><Population><Prevalence><Principal Investigator><Property><Prospective cohort><Public Health><Qualifying><Reporting><Research><Research Personnel><Research Resources><Researchers><Resource Allocation><Resources><Risk Factors><Roxanol><Sampling><Self-Report><Standardization><Statex SR><System><Temporal trend><Testing><Time><Time trend><Toxic Chemical><Toxic Substance><Toxicology><Trends over time><Visit><abuse liability><abuse of drugs><abuse potential><abused drug><abused drugs><abuses drugs><alpha-aminopropiophenone><analytic epidemiology><analytical epidemiology><biologic><cathinine><cathinone><clinical effect><clinical predictors><clinical risk><cohort><cost><data streams><demographics><design><designing><diamorphine overdose><drug abused><drug of abuse><drug use><drug/agent><drugs abused><drugs of abuse><enroll><epidemiologic><epidemiological><fentalogs><fentalogues><fentanyl analog><heroin overdose><hospital days><hospital length of stay><hospital stay><illicit opiate><illicit opioid><improved><ingest><injury to organs><licit opioid><mechanical respiratory assist><mechanically ventilated><multidisciplinary><naloxone dosing><novel><opiate consumption><opiate crisis><opiate deaths><opiate drug use><opiate intake><opiate medication><opiate mortality><opiate overdose><opiate related overdose><opiate use><opioid consumption><opioid crisis><opioid deaths><opioid drug overdose><opioid drug use><opioid epidemic><opioid induced overdose><opioid intake><opioid intoxication><opioid medication><opioid medication overdose><opioid mortality><opioid overdose><opioid overdose death><opioid poisoning><opioid related death><opioid related overdose><opioid toxicity><opioid use><organ injury><overdose death><overdose fatalities><patient registry><periodic><periodical><prescribed opiate><prescribed opioid><prescription opiate><prescription opioid><prospective><psychostimulant><regional difference><screening><screenings><sedative><sex><stem><substance use><substance using><suicidal><suicidality><synthetic cannabinoid><synthetic opiate><synthetic opioid><tandem mass spectrometry><time of flight mass spectrometry><toxic compound><trend><trend analysis>