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Principal Investigator: Alex Francis Manini
Organization: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Fiscal Year: 2020
Award: $149,395
Funding agency: National Institute on Drug Abuse
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.
Terms: <2019 novel coronavirus><2019-nCoV><21+ years old><AOD use><Accident and Emergency department><Actiq><Adanon><Address><Adult><Adult Human><Adverse effects><Affect><Alcohol or Other Drugs use><Althose><American><Assay><Azadose><Azithromycin><Azitrocin><Azythromycin><Bioassay><Biologic Assays><Biological Assay><COVID-19><COVID-19 epidemic><COVID-19 pandemic><COVID19><COVID19 epidemic><COVID19 pandemic><Cardiovascular><Cardiovascular Body System><Cardiovascular Organ System><Cardiovascular system><Cessation of life><Clinical><Clinical Data><Collaborations><Commerce><Critical Care><Critical Illness><Critically Ill><Data><Data Bases><Data Collection><Databases><Death><Diacetylmorphine><Diamorphine><Disease Outcome><Dolophine><Drug Interactions><Drug abuse><Drugs><Duragesic><ED care><ED patient><ED visit><ER care><ER patient><ER visit><Emergency Care><Emergency Department><Emergency Department care><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><Environmental Factor><Environmental Risk Factor><Epidemiology><Evaluation><Event><Failure><Fentanest><Fentanyl><Fentyl><Grant><Health><Heart Vascular><Heroin><Home><Home environment><Homelessness><Hospitals><Hydroxychlorochin><Hydroxychloroquine><Immune><Immunes><Imprisonment><Incidence><Individual><Infection><Infrastructure><Inpatients><Institution><Investigators><Knowledge><Laboratories><Lung><Lung Respiratory System><Marijuana><Measures><Mechanical ventilation><Medical><Medical Records><Medication><Methadone><Methadose><Molecular><NIDA><Naloxone><National Institute of Drug Abuse><National Institute on Drug Abuse><Opiate user><Opiates><Opioid><Opioid drug user><Outcome><Overdose><Oxychlorochin><Oxychloroquine><PWUO><Patients><Pharmaceutic Preparations><Pharmaceutical Preparations><Phentanyl><Population><Prevalence><Principal Investigator><Prospective cohort><Public Health><Registries><Research><Research Activity><Research Personnel><Research Resources><Researchers><Resources><Respiratory Depression><Rest><Risk><Risk Factors><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Severe acute respiratory syndrome coronavirus 2><Severities><Substance Use Disorder><Substance of Abuse><Swab><Time><Toxicology><Transmission><Ultreon><United States><Vent><Ventilator><Ventilatory Depression><Wuhan coronavirus><Zithromax><Zitromax><abuse of drugs><abuses drugs><adulthood><analog><base><circulatory system><clinical risk><cohort><corona virus disease 2019><corona virus disease 2019 epidemic><corona virus disease 2019 pandemic><coronavirus disease 2019><coronavirus disease 2019 epidemic><coronavirus disease 2019 pandemic><cost><data base><data streams><depressed breathing><depression of breathing><drug/agent><enroll><environmental risk><epidemiologic><epidemiological><experience><homeless><illicit opiate><illicit opioid><improved><incarcerated><incarceration><interest><licit opioid><marihuana><mechanical respiratory assist><multidisciplinary><novel><opiate consumption><opiate crisis><opiate drug use><opiate intake><opiate medication><opiate overdose><opiate related overdose><opiate use><opiate use disorder><opioid consumption><opioid crisis><opioid drug overdose><opioid drug use><opioid epidemic><opioid induced overdose><opioid intake><opioid intoxication><opioid medication><opioid medication overdose><opioid overdose><opioid poisoning><opioid related overdose><opioid toxicity><opioid use><opioid use disorder><opioid user><overdose death><pandemic><pandemic disease><patient registry><patients who use opioids><people who use opioids><persons who use opioids><population health><prescribed opiate><prescribed opioid><prescription opiate><prescription opioid><prospective><pulmonary><respiratory><response><social factors><statistics><stem><substance use><substance using><substances of abuse><synthetic opiate><synthetic opioid><transmission process><trend><unhoused><using substances><vaping>