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

NCT ID: NCT02897414

Last Updated: 2016-09-13

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

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Recruitment Status

UNKNOWN

Total Enrollment

13015 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid-related Disorders Opioid Addiction Narcotic Abuse Drug Abuse

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Overall group of all ER/LA opioid excluding hydrocodone

Surveillance of state medical examiner databases

Intervention Type OTHER

Each type of opioid that has an ER/LA opioid formulation

Surveillance of state medical examiner databases

Intervention Type OTHER

Overall group that includes all prescription opioids except

Surveillance of state medical examiner databases

Intervention Type OTHER

Comparator Group taking benzodiazepines

Surveillance of state medical examiner databases

Intervention Type OTHER

Comparator Group taking IR hydrocodone

Surveillance of state medical examiner databases

Intervention Type OTHER

Interventions

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Surveillance of state medical examiner databases

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ER/LA Opioid REMS Program Companies (RPC)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Assessment 5.5

Identifier Type: -

Identifier Source: org_study_id

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