Opioid-related DisordersNCT02871232
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
An observational study of Opioid-related Disorders and Opioid Addiction, run by ER/LA Opioid REMS Program Companies (RPC).
Trial summary
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. 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?
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
- How many people
- 26,500 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: The Poison Center Program obtains data from the general population of the US, Treatment Center Programs obtain data from those entering treatment for opioid addiction, and the College Survey Program surveys self-identified students attending a 2- or 4- year college, university, or technical school
Who may be able to join
- Any patient with data in the RADARS system
Who cannot join
- None
About this study
Official title: Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
- 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.
Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversionOther
| Study group | Role | What they receive |
|---|---|---|
| Intentional exposures among adolescents and adults | Not described Receives: Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion | |
| Unintentional exposures among infants and children | Not described Receives: Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups
Measured: Review over period from January 2010 to December 2016
Secondary outcomes (1)
Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group
Measured: Review over period from January 2010 to December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 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
- Cohort
- Enrolment
- 26,500 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
- NCT02871232
- Sponsor's protocol ID
- Assessments 5.2-5.4
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol
- ClinicalTrials.gov ID
- NCT02871232
- Acronym / sponsor ID
- Assessments 5.2-5.4
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26,500 participants (estimated)
- Lead sponsor
- ER/LA Opioid REMS Program Companies (RPC)Industry (pharma, biotech, devices)
- Primary completion
- Dec 2016 (estimated)
- First posted
- 18 Aug 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.
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intentional exposures among adolescents and adults | – | Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion |
| Unintentional exposures among infants and children | – | Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The Poison Center Program obtains data from the general population of the US, Treatment Center Programs obtain data from those entering treatment for opioid addiction, and the College Survey Program surveys self-identified students attending a 2- or 4- year college, university, or technical school
Key inclusion criteria (1 listed)
- Any patient with data in the RADARS system
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 |
|---|---|---|
| Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion | Other | Intentional exposures among adolescents and adults, Unintentional exposures among infants and children |
Primary outcome
Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups
Time frame: Review over period from January 2010 to December 2016
1 secondary outcome
Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group
Time frame: Review over period from January 2010 to December 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 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 25 Aug 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?
Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups (time frame: Review over period from January 2010 to December 2016). 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 25 Aug 2016.