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

• Sponsor: ER/LA Opioid REMS Program Companies (RPC) (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02897414
• Collaborator: (none)
• Enrollment: 13,015

Study Details

Study Description

Brief Summary

In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support national efforts to reduce serious adverse outcomes resulting from opioid abuse. This study will evaluate trends before and after the ER/LA REMS implementation for changes in mortality rates associated with prescription opioids utilizing state medical examiner databases from multiple states. Databases from 2005 through the most recent year available will be obtained.

Condition or Disease	Intervention/Treatment	Phase
Opioid-related Disorders; Opioid Addiction; Narcotic Abuse; Drug Abuse	Other: Surveillance of state medical examiner databases

Study Design

• Study Type: Observational
• Anticipated Enrollment: 13015 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• Official Title: Extended Release/Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Medical Examiner Surveillance Monitoring Protocol
• Anticipated Primary Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Overall group of all ER/LA opioid excluding hydrocodone	Other: Surveillance of state medical examiner databases
Each type of opioid that has an ER/LA opioid formulation	Other: Surveillance of state medical examiner databases
Overall group that includes all prescription opioids except	Other: Surveillance of state medical examiner databases
Comparator Group taking benzodiazepines	Other: Surveillance of state medical examiner databases
Comparator Group taking IR hydrocodone	Other: Surveillance of state medical examiner databases

Outcome Measures

Primary Outcome Measures

1. Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems [Review over period from January 2005 to 2016]

2. Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states [Review over period from January 2005 to 2016]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Fatalities associated with prescription opioids in several states during 2005-2015 (or later).

Exclusion Criteria:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ER/LA Opioid REMS Program Companies (RPC)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ER/LA Opioid REMS Program Companies (RPC)
• ClinicalTrials.gov Identifier: NCT02897414
• Other Study ID Numbers: Assessment 5.5
• First Posted: Sep 13, 2016
• Last Update Posted: Sep 13, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Narcotic-Related Disorders

Study Results

No Results Posted as of Sep 13, 2016