xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05976984</url>
    </required_header>
    <id_info>
      <org_study_id>850003</org_study_id>
      <nct_id>NCT05976984</nct_id>
    </id_info>
    <brief_title>Stimulant Overdose in the Medicaid Population: Who is at Risk, and When Are They at Risk</brief_title>
    <official_title>Stimulant Overdose in the Medicaid Population: Who is at Risk, and When Are They at Risk</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pennsylvania</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project addresses Objective 2 of RFA-CE-21-002: to assess risk and protective factors&#xD;
        for illicit stimulant use, use disorder, or overdose that can contribute to the development&#xD;
        or adaptation of intervention strategies. The study will 1) develop and validate a model&#xD;
        using both person-level and area-level characteristics to identify, among Medicaid enrollees&#xD;
        age 15 and older, who is at highest risk of an inpatient hospitalization or emergency&#xD;
        department (ED) encounter for overdose from cocaine or other stimulants; 2) develop and&#xD;
        validate a model to identify, among those Medicaid enrollees age 15 and older at highest risk&#xD;
        of an inpatient hospitalization or ED encounter for stimulant overdose, when they are at&#xD;
        highest risk; and 3) among those Medicaid enrollees age 15 and above with a prior inpatient&#xD;
        hospitalization or ED encounter for stimulant overdose, to measure the rate of and identify&#xD;
        risk and protective factors for a subsequent inpatient hospitalization or ED encounter for&#xD;
        overdose from stimulants and/or opioids.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The US drug overdose epidemic has grown dramatically in the past twenty years, with more than&#xD;
        70,000 fatal drug overdoses in 2019 alone. This growth in overdose deaths is a major&#xD;
        contributor to the multiyear decline in US life expectancy that was seen even before the&#xD;
        COVID-19 pandemic began. The drugs responsible for the largest increases in overdose deaths&#xD;
        are synthetic opioids, cocaine, and other stimulants (primarily methamphetamine). In&#xD;
        recognition of the increasing role that cocaine and other stimulants are playing in the drug&#xD;
        overdose epidemic, the US Centers for Disease Control and Prevention (CDC) has called for&#xD;
        increased surveillance and evidence-based prevention and response strategies to address&#xD;
        overdoses involving these agents. While rates of stimulant use and overdose have been&#xD;
        reported to vary by demographics, physical and mental health conditions, disability, and&#xD;
        other factors, no prior research has linked individual-level data on demographics,&#xD;
        disability, and social determinants of health together with granular measures derived from&#xD;
        healthcare utilization records, with comprehensive, area-level data on social deprivation to&#xD;
        develop knowledge about risk and protective factors for stimulant overdose. Further, no prior&#xD;
        research has focused on stimulant overdose in Medicaid enrollees, a large, vulnerable,&#xD;
        underserved population in whom half of all amphetamine-related hospitalizations occur. This&#xD;
        project addresses Objective 2 of RFA-CE-21-002: to assess risk and protective factors for&#xD;
        illicit stimulant use, use disorder, or overdose that can contribute to the development or&#xD;
        adaptation of intervention strategies. The study will 1) develop and validate a model using&#xD;
        both person-level characteristics (including demographic characteristics, household income,&#xD;
        diagnoses, prescriptions, and healthcare utilization) and area-level characteristics&#xD;
        (including a wide range of measures of socioeconomic deprivation) to identify, among Medicaid&#xD;
        enrollees age 15 and older, who is at highest risk of an inpatient hospitalization or&#xD;
        emergency department (ED) encounter for overdose from cocaine or other stimulants; 2) develop&#xD;
        and validate a model to identify, among those Medicaid enrollees age 15 and older at highest&#xD;
        risk of an inpatient hospitalization or ED encounter for stimulant overdose, when they are at&#xD;
        highest risk; and 3) among those Medicaid enrollees age 15 and above with a prior inpatient&#xD;
        hospitalization or ED encounter for stimulant overdose, to measure the rate of and identify&#xD;
        risk and protective factors for a subsequent inpatient hospitalization or ED encounter for&#xD;
        overdose from stimulants and/or opioids. The results will be useful in at least two ways.&#xD;
        First, they will provide generalizable knowledge about the individual-level and social&#xD;
        factors that predispose to or protect against stimulant overdose. Such etiologic factors can&#xD;
        then be the targets of intervention at the national, state, county, and local levels to&#xD;
        ameliorate the effects of these causes, as well as the basis of future research to better&#xD;
        understand the underlying causal mechanisms. Second, the results can be used pragmatically to&#xD;
        identify high-risk individuals for the purpose of targeting scarce resources for&#xD;
        evidence-based approaches to overdose prevention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 30, 2021</start_date>
    <completion_date type="Anticipated">September 29, 2024</completion_date>
    <primary_completion_date type="Actual">November 16, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of stimulant overdose</measure>
      <time_frame>2016-2020</time_frame>
      <description>Rate of inpatient hospitalization or emergency department visit for overdose due to cocaine or other stimulants (Aims 1&amp;2)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of stimulant or opioid overdose</measure>
      <time_frame>2016-2020</time_frame>
      <description>Rate of inpatient hospitalization or emergency department visit for overdose from a stimulant and/or an opioid (Aim 3)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">634939</enrollment>
    <condition>Stimulant Overdose</condition>
    <arm_group>
      <arm_group_label>Medicaid enrollees</arm_group_label>
      <description>Medicaid enrollees age15 years or older 2016-2020</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Aim 1 (case-cohort study)</intervention_name>
      <description>Cases: All Medicaid enrollees age 15 years or older with at least one inpatient hospitalization or emergency department visit indicating a stimulant overdose during 2016-2020&#xD;
  Subcohort: A random sample of all Medicaid enrollees age 15 years or older irrespective of their stimulant overdose history during 2016-2020</description>
      <arm_group_label>Medicaid enrollees</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Aim 2 (case-crossover study)</intervention_name>
      <description>Case period: 60 days before the date of stimulant overdose through the day before the date of stimulant overdose&#xD;
  Control period: 179 days before the date of stimulant overdose through 120 days before the date of stimulant overdose&#xD;
  Washout period: 119 days before the date of stimulant overdose through 61 days before the date of stimulant overdose</description>
      <arm_group_label>Medicaid enrollees</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Aim 3 (cohort study)</intervention_name>
      <description>All Medicaid enrollees age 15 years or older with at least one inpatient hospitalization or emergency department visit indicating a stimulant overdose during 2016-2020</description>
      <arm_group_label>Medicaid enrollees</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population is a case-cohort sample, with the cases being all Medicaid enrollees&#xD;
          ages 15 years or older who had at least one inpatient hospitalization or emergency&#xD;
          department encounter indicating a stimulant overdose during 2016-2020, and the subcohort&#xD;
          being a random sample of all Medicaid enrollees ages 15 years or older irrespective of&#xD;
          their stimulant overdose history. Aim 1 analysis will make full use of the case-cohort&#xD;
          sample, whereas Aims 2 and 3 analyses will be restricted to the cases.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Cases: Medicaid enrollees who (1) had an inpatient hospitalization or emergency&#xD;
               department encounter indicating a stimulant overdose during 2016-2020, (2) had been&#xD;
               continuously enrolled in Medicaid from January 1st of the year preceding the year in&#xD;
               which the stimulant overdose occurred, and (3) were 15 years old or older as of&#xD;
               January 1 of the year of the overdose.&#xD;
  &#xD;
            -  Random subcohort: Medicaid enrollees who (1) had been continuously enrolled in&#xD;
               Medicaid for at least one calendar year during 2015-2019, and (2) were 15 years old or&#xD;
               older as of January 1 of one year following the last year of continuous enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Medicaid enrollees whose data were in the format of Medicaid Analytic eXtract (MAX) in&#xD;
               2015&#xD;
  &#xD;
            -  Medicaid enrollees whose residence zip code is missing or in Puerto Rico or Virgin&#xD;
               Islands&#xD;
  &#xD;
            -  Medicaid enrollees whose residence zip code does not correspond to any ZIP Code&#xD;
               Tabulation Area (ZCTA) in the American Community Survey 5-year data&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sean Hennessy, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>UNIVERSITY OF PENNSYLVANIA Perelman SCHOOLS OF MEDICINE</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
      <investigator_full_name>Sean Hennessy</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>stimulant</keyword>
    <keyword>overdose</keyword>
    <keyword>Medicaid</keyword>
    <keyword>prediction</keyword>
    <keyword>risk factor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Drug Overdose</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>CMS does not allow users/license holders to make data available to the public.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05976984
  org study id: 850003
  nct id: NCT05976984
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This project addresses Objective 2 of RFA-CE-21-002: to assess risk and protective factors
        for illicit stimulant use, use disorder, or overdose that can contribute to the development
        or adaptation of intervention strategies. The study will 1) develop and validate a model
        using both person-level and area-level characteristics to identify, among Medicaid enrollees
        age 15 and older, who is at highest risk of an inpatient hospitalization or emergency
        department (ED) encounter for overdose from cocaine or other stimulants; 2) develop and
        validate a model to identify, among those Medicaid enrollees age 15 and older at highest risk
        of an inpatient hospitalization or ED encounter for stimulant overdose, when they are at
        highest risk; and 3) among those Medicaid enrollees age 15 and above with a prior inpatient
        hospitalization or ED encounter for stimulant overdose, to measure the rate of and identify
        risk and protective factors for a subsequent inpatient hospitalization or ED encounter for
        overdose from stimulants and/or opioids.
  The US drug overdose epidemic has grown dramatically in the past twenty years, with more than
        70,000 fatal drug overdoses in 2019 alone. This growth in overdose deaths is a major
        contributor to the multiyear decline in US life expectancy that was seen even before the
        COVID-19 pandemic began. The drugs responsible for the largest increases in overdose deaths
        are synthetic opioids, cocaine, and other stimulants (primarily methamphetamine). In
        recognition of the increasing role that cocaine and other stimulants are playing in the drug
        overdose epidemic, the US Centers for Disease Control and Prevention (CDC) has called for
        increased surveillance and evidence-based prevention and response strategies to address
        overdoses involving these agents. While rates of stimulant use and overdose have been
        reported to vary by demographics, physical and mental health conditions, disability, and
        other factors, no prior research has linked individual-level data on demographics,
        disability, and social determinants of health together with granular measures derived from
        healthcare utilization records, with comprehensive, area-level data on social deprivation to
        develop knowledge about risk and protective factors for stimulant overdose. Further, no prior
        research has focused on stimulant overdose in Medicaid enrollees, a large, vulnerable,
        underserved population in whom half of all amphetamine-related hospitalizations occur. This
        project addresses Objective 2 of RFA-CE-21-002: to assess risk and protective factors for
        illicit stimulant use, use disorder, or overdose that can contribute to the development or
        adaptation of intervention strategies. The study will 1) develop and validate a model using
        both person-level characteristics (including demographic characteristics, household income,
        diagnoses, prescriptions, and healthcare utilization) and area-level characteristics
        (including a wide range of measures of socioeconomic deprivation) to identify, among Medicaid
        enrollees age 15 and older, who is at highest risk of an inpatient hospitalization or
        emergency department (ED) encounter for overdose from cocaine or other stimulants; 2) develop
        and validate a model to identify, among those Medicaid enrollees age 15 and older at highest
        risk of an inpatient hospitalization or ED encounter for stimulant overdose, when they are at
        highest risk; and 3) among those Medicaid enrollees age 15 and above with a prior inpatient
        hospitalization or ED encounter for stimulant overdose, to measure the rate of and identify
        risk and protective factors for a subsequent inpatient hospitalization or ED encounter for
        overdose from stimulants and/or opioids. The results will be useful in at least two ways.
        First, they will provide generalizable knowledge about the individual-level and social
        factors that predispose to or protect against stimulant overdose. Such etiologic factors can
        then be the targets of intervention at the national, state, county, and local levels to
        ameliorate the effects of these causes, as well as the basis of future research to better
        understand the underlying causal mechanisms. Second, the results can be used pragmatically to
        identify high-risk individuals for the purpose of targeting scarce resources for
        evidence-based approaches to overdose prevention.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Rate of stimulant overdose
  time frame: 2016-2020
  description: Rate of inpatient hospitalization or emergency department visit for overdose due to cocaine or other stimulants (Aims 1&2)
  measure: Rate of stimulant or opioid overdose
  time frame: 2016-2020
  description: Rate of inpatient hospitalization or emergency department visit for overdose from a stimulant and/or an opioid (Aim 3)
  arm group label: Medicaid enrollees
  description: Medicaid enrollees age15 years or older 2016-2020
  intervention type: Other
  intervention name: Aim 1 (case-cohort study)
  description: Cases: All Medicaid enrollees age 15 years or older with at least one inpatient hospitalization or emergency department visit indicating a stimulant overdose during 2016-2020
  Subcohort: A random sample of all Medicaid enrollees age 15 years or older irrespective of their stimulant overdose history during 2016-2020
  arm group label: Medicaid enrollees
  intervention type: Other
  intervention name: Aim 2 (case-crossover study)
  description: Case period: 60 days before the date of stimulant overdose through the day before the date of stimulant overdose
  Control period: 179 days before the date of stimulant overdose through 120 days before the date of stimulant overdose
  Washout period: 119 days before the date of stimulant overdose through 61 days before the date of stimulant overdose
  arm group label: Medicaid enrollees
  intervention type: Other
  intervention name: Aim 3 (cohort study)
  description: All Medicaid enrollees age 15 years or older with at least one inpatient hospitalization or emergency department visit indicating a stimulant overdose during 2016-2020
  arm group label: Medicaid enrollees
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sean Hennessy, PhD
  role: Principal Investigator
  affiliation: University of Pennsylvania
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pennsylvania
  investigator full name: Sean Hennessy
  investigator title: Professor
  mesh term: Drug Overdose
  sharing ipd: No
  ipd description: CMS does not allow users/license holders to make data available to the public.