Stimulant Overdose in the Medicaid Population: Who is at Risk, and When Are They at Risk

NCT05976984 | Completed

• 1 other identifier: 850003
• Study Type: observational
• Target: 634,939
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stimulant Overdose

Keywords

stimulant; overdose; Medicaid; prediction; risk factor

Outcome Measures

Primary Outcomes (1)

• Rate of stimulant overdose

  Rate of inpatient hospitalization or emergency department visit for overdose due to cocaine or other stimulants (Aims 1\&2)

  2016-2020

Secondary Outcomes (1)

• Rate of stimulant or opioid overdose

  2016-2020

Study Arms (1)

Medicaid enrollees

Medicaid enrollees age15 years or older 2016-2020

Other: Aim 1 (case-cohort study); Other: Aim 2 (case-crossover study); Other: Aim 3 (cohort study)

Interventions

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

Medicaid enrollees

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

Medicaid enrollees

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

Medicaid enrollees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

UNIVERSITY OF PENNSYLVANIA Perelman SCHOOLS OF MEDICINE

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Drug Overdose

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sean Hennessy, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: September 30, 2021
• Primary Completion: November 16, 2022
• Study Completion: August 18, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)