Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers

Opioid-related Disorders Clinical Trial

Official title:

Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02871232
• Other study ID #: Assessments 5.2-5.4
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 15, 2016
• Last updated: August 24, 2016

Study information

• Verified date: August 2016
• Source: ER/LA Opioid REMS Program Companies (RPC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 26500
• Est. primary completion date: December 2016
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Any patient with data in the RADARS system

Exclusion Criteria:

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Drug Abuse
• Narcotic Abuse
• Opioid Addiction
• Opioid-related Disorders
• Substance-Related Disorders

Intervention

Other:
• Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ER/LA Opioid REMS Program Companies (RPC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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