ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

183452 participants

Study Classification

OBSERVATIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases

NCT02897414

UNKNOWN

Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers

NCT02871232

UNKNOWN

Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics

NCT02662153

Opioid Overdose

COMPLETED

Safe Opioid Prescription Practice for Patients Discharged From Trauma Services

NCT02584881

Opioids Drug Prescription

UNKNOWN NA

Primary Care Intervention to Reduce Prescription Opioid Overdoses

NCT02464410

Pain Drug Overdose Opioid Use Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

As part of the FDA-approved plan to evaluate the effects of the REMS program, the REMS Program Companies (RPC) are required to submit FDA assessment reports on a regular basis. The present study is one of several program evaluation components carried out in support Assessment 5: Surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. This study will evaluate the impact of the ER/LA opioid REMS program on the incidence of ED visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid-related Disorders Opioid Addiction Narcotic Abuse Drug Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All commercially insured patients in the HIRD

Retrospective database review

Intervention Type OTHER

All Medicaid patients in a participating state Medicaid plan

Retrospective database review

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Retrospective database review

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. At least one dispensing of an ER/LA opioid after 01 July 2010
2. At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period