Stimulant OverdoseNCT05976984
Stimulant Overdose in the Medicaid Population: Who is at Risk, and When Are They at Risk
An observational study of Stimulant Overdose, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stimulant Overdose
- What is being tested?
- Aim 1 (case-cohort study), Aim 2 (case-crossover study) and Aim 3 (cohort study)
- How many people
- 634,939 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 18 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is a case-cohort sample, with the cases being all Medicaid enrollees ages 15 years or older who had at least one inpatient hospitalization or emergency department encounter indicating a stimulant overdose during 2016-2020, and the subcohort being a random sample of all Medicaid enrollees ages 15 years or older irrespective of their stimulant overdose history. Aim 1 analysis will make full use of the case-cohort sample, whereas Aims 2 and 3 analyses will be restricted to the cases.
Who may be able to join
- Cases: Medicaid enrollees who (1) had an inpatient hospitalization or emergency department encounter indicating a stimulant overdose during 2016-2020, (2) had been continuously enrolled in Medicaid from January 1st of the year preceding the year in which the stimulant overdose occurred, and (3) were 15 years old or older as of January 1 of the year of the overdose.
- Random subcohort: Medicaid enrollees who (1) had been continuously enrolled in Medicaid for at least one calendar year during 2015-2019, and (2) were 15 years old or older as of January 1 of one year following the last year of continuous enrollment.
Who cannot join
- Medicaid enrollees whose data were in the format of Medicaid Analytic eXtract (MAX) in 2015
- Medicaid enrollees whose residence zip code is missing or in Puerto Rico or Virgin Islands
- Medicaid enrollees whose residence zip code does not correspond to any ZIP Code Tabulation Area (ZCTA) in the American Community Survey 5-year data
Trial locations and contacts
1 site in 1 country.
United States1 site
UNIVERSITY OF PENNSYLVANIA Perelman SCHOOLS OF MEDICINE
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
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.
- Conditions
- Stimulant Overdose
- Being tested
- Aim 1 (case-cohort study), Aim 2 (case-crossover study), Aim 3 (cohort study)
- Keywords
- stimulant, overdose, Medicaid, prediction, risk factor
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim 1 (case-cohort study)Other
- 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
Aim 2 (case-crossover study)Other
- 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
Aim 3 (cohort study)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Medicaid enrollees | Medicaid enrollees age15 years or older 2016-2020 Receives: Other: Aim 1 (case-cohort study); Other: Aim 2 (case-crossover study); Other: Aim 3 (cohort study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stimulant overdose
Rate of inpatient hospitalization or emergency department visit for overdose due to cocaine or other stimulants (Aims 1\&2)
Measured: 2016-2020
Secondary outcomes (1)
Rate of stimulant or opioid overdose
Rate of inpatient hospitalization or emergency department visit for overdose from a stimulant and/or an opioid (Aim 3)
Measured: 2016-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start30 Sep 2021
- Primary completion16 Nov 2022
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant OverdoseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 634,939 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Hennessy, University of Pennsylvania
- Investigators
- Sean Hennessy, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976984
- Sponsor's protocol ID
- 850003
- Status last verified
- Sep 2025
- First submitted
- 27 Jul 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: CMS does not allow users/license holders to make data available to the public.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulant Overdose in the Medicaid Population: Who is at Risk, and When Are They at Risk
- ClinicalTrials.gov ID
- NCT05976984
- Acronym / sponsor ID
- 850003
- Conditions
- Stimulant Overdose
- Keywords
- stimulant, overdose, Medicaid, prediction, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 634,939 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medicaid enrollees | – | Other: Aim 1 (case-cohort study), Other: Aim 2 (case-crossover study), Other: Aim 3 (cohort study)Medicaid enrollees age15 years or older 2016-2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is a case-cohort sample, with the cases being all Medicaid enrollees ages 15 years or older who had at least one inpatient hospitalization or emergency department encounter indicating a stimulant overdose during 2016-2020, and the subcohort being a random sample of all Medicaid enrollees ages 15 years or older irrespective of their stimulant overdose history. Aim 1 analysis will make full use of the case-cohort sample, whereas Aims 2 and 3 analyses will be restricted to the cases.
Key inclusion criteria (2 listed)
- Cases: Medicaid enrollees who (1) had an inpatient hospitalization or emergency department encounter indicating a stimulant overdose during 2016-2020, (2) had been continuously enrolled in Medicaid from January 1st of the year preceding the year in which the stimulant overdose occurred, and (3) were 15 years old or older as of January 1 of the year of the overdose.
- Random subcohort: Medicaid enrollees who (1) had been continuously enrolled in Medicaid for at least one calendar year during 2015-2019, and (2) were 15 years old or older as of January 1 of one year following the last year of continuous enrollment.
Key exclusion criteria (3 listed)
- Medicaid enrollees whose data were in the format of Medicaid Analytic eXtract (MAX) in 2015
- Medicaid enrollees whose residence zip code is missing or in Puerto Rico or Virgin Islands
- Medicaid enrollees whose residence zip code does not correspond to any ZIP Code Tabulation Area (ZCTA) in the American Community Survey 5-year data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aim 1 (case-cohort study)* 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 | Other | Medicaid enrollees |
| Aim 2 (case-crossover study)* 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 | Other | Medicaid enrollees |
| Aim 3 (cohort study)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 | Other | Medicaid enrollees |
Primary outcome
Rate of stimulant overdose
Time frame: 2016-2020
Rate of inpatient hospitalization or emergency department visit for overdose due to cocaine or other stimulants (Aims 1\&2)
1 secondary outcome
Rate of stimulant or opioid overdose
Time frame: 2016-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No. CMS does not allow users/license holders to make data available to the public.
Related trials for Stimulant Overdose
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Recovery Management Checkup Scalability and Sustainability Hybrid Experiment
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Recruiting
Kentucky Women's Justice Community Overdose Innovation Network - Phase II
Overdose Risk, Opioid Use Disorder
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Naltrexone for Overdose Prevention
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Hennessy, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stimulant Overdose, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of stimulant overdose (time frame: 2016-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.