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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT05976984
Study groupRoleWhat they receive
Medicaid enrolleesMedicaid 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.

  1. 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)
  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.

  1. First posted4 Aug 2023
  2. Study start30 Sep 2021
  3. Primary completion16 Nov 2022
  4. Study completion18 Aug 2025

Resources

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)
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.

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.

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