NCT02897414

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,015

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

First QC Date

August 10, 2016

Last Update Submit

September 7, 2016

Conditions

Opioid-related DisordersOpioid AddictionNarcotic AbuseDrug Abuse

Outcome Measures

Primary Outcomes (2)

  • Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems

    Review over period from January 2005 to 2016

  • Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states

    Review over period from January 2005 to 2016

Study Arms (5)

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

Interventions

Surveillance of state medical examiner databasesOTHER
Comparator Group taking IR hydrocodoneComparator Group taking benzodiazepinesEach type of opioid that has an ER/LA opioid formulationOverall group of all ER/LA opioid excluding hydrocodoneOverall group that includes all prescription opioids except

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fatalities associated with prescription opioids as reported in State medical examiner databases from multiple states.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

September 13, 2016

Primary Completion

December 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09