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

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ClinicalTrials.gov Identifier: NCT02897414
Recruitment Status : Unknown
Verified September 2016 by ER/LA Opioid REMS Program Companies (RPC).
Recruitment status was:  Enrolling by invitation
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
ER/LA Opioid REMS Program Companies (RPC)

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
Opioid-related Disorders Opioid Addiction Narcotic Abuse Drug Abuse Other: Surveillance of state medical examiner databases

Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort 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



Primary Outcome Measures :
  1. Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems [ Time Frame: Review over period from January 2005 to 2016 ]
  2. Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states [ Time Frame: Review over period from January 2005 to 2016 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Fatalities associated with prescription opioids as reported in State medical examiner databases from multiple states.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Responsible Party: ER/LA Opioid REMS Program Companies (RPC)
ClinicalTrials.gov Identifier: NCT02897414     History of Changes
Other Study ID Numbers: Assessment 5.5
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Hydrocodone
Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents