Opioid-related DisordersNCT02897414
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases
An observational study of Opioid-related Disorders and Opioid Addiction, run by ER/LA Opioid REMS Program Companies (RPC).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse
- What is being tested?
- Surveillance of state medical examiner databases
- How many people
- 13,015 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Fatalities associated with prescription opioids as reported in State medical examiner databases from multiple states.
Who may be able to join
- Fatalities associated with prescription opioids in several states during 2005-2015 (or later).
Who cannot join
- None
About this study
Official title: Extended Release/Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Medical Examiner Surveillance Monitoring Protocol
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.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- Surveillance of state medical examiner databases
- Medical subject headings
- Opioid-Related Disorders, Narcotic-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveillance of state medical examiner databasesOther
| Study group | Role | What they receive |
|---|---|---|
| Overall group of all ER/LA opioid excluding hydrocodone | Not described Receives: Other: Surveillance of state medical examiner databases | |
| Each type of opioid that has an ER/LA opioid formulation | Not described Receives: Other: Surveillance of state medical examiner databases | |
| Overall group that includes all prescription opioids except | Not described Receives: Other: Surveillance of state medical examiner databases | |
| Comparator Group taking benzodiazepines | Not described Receives: Other: Surveillance of state medical examiner databases | |
| Comparator Group taking IR hydrocodone | Not described Receives: Other: Surveillance of state medical examiner databases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems
Measured: Review over period from January 2005 to 2016
Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states
Measured: Review over period from January 2005 to 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 13,015 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ER/LA Opioid REMS Program Companies (RPC)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897414
- Sponsor's protocol ID
- Assessment 5.5
- Status last verified
- Sep 2016
- First submitted
- 10 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Release/Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Medical Examiner Surveillance Monitoring Protocol
- ClinicalTrials.gov ID
- NCT02897414
- Acronym / sponsor ID
- Assessment 5.5
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13,015 participants (estimated)
- Lead sponsor
- ER/LA Opioid REMS Program Companies (RPC)Industry (pharma, biotech, devices)
- Primary completion
- Dec 2016 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Fatalities associated with prescription opioids as reported in State medical examiner databases from multiple states.
Key inclusion criteria (1 listed)
- Fatalities associated with prescription opioids in several states during 2005-2015 (or later).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surveillance of state medical examiner databases | Other | Comparator Group taking IR hydrocodone, Comparator Group taking benzodiazepines, Each type of opioid that has an ER/LA opioid formulation, Overall group of all ER/LA opioid excluding hydrocodone, Overall group that includes all prescription opioids except |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-related Disorders and Opioid Addiction, run by ER/LA Opioid REMS Program Companies (RPC).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.