Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers

August 24, 2016 updated by: ER/LA Opioid REMS Program Companies (RPC)

Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol

To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

26500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Poison Center Program obtains data from the general population of the US, Treatment Center Programs obtain data from those entering treatment for opioid addiction, and the College Survey Program surveys self-identified students attending a 2- or 4- year college, university, or technical school

Description

Inclusion Criteria:

Any patient with data in the RADARS system

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intentional exposures among adolescents and adults
Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
Unintentional exposures among infants and children
Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups
Time Frame: Review over period from January 2010 to December 2016
Review over period from January 2010 to December 2016

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group
Time Frame: Review over period from January 2010 to December 2016
Review over period from January 2010 to December 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ER/LA Opioid REMS Program Companies (RPC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assessments 5.2-5.4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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