Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
Sponsor
ER/LA Opioid REMS Program Companies (RPC) (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02871232
Collaborator
(none)
26,500
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
26500 participants
Observational Model:
Cohort
Official Title:
Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol
Anticipated Primary Completion Date
:
Dec 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- 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 [Review over period from January 2010 to December 2016]
Secondary Outcome Measures
- Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group [Review over period from January 2010 to December 2016]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
Any patient with data in the RADARS system
Exclusion Criteria:
None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ER/LA Opioid REMS Program Companies (RPC)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ER/LA Opioid REMS Program Companies (RPC)
ClinicalTrials.gov Identifier:
NCT02871232
Other Study ID Numbers:
- Assessments 5.2-5.4
First Posted:
Aug 18, 2016
Last Update Posted:
Aug 25, 2016
Last Verified:
Aug 1, 2016
Additional relevant MeSH terms: