NCT02871232

Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 26,500 (estimated)
• Sponsor: ER/LA Opioid REMS Program Companies (RPC) · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion

Timeline

• Primary completion: 2016-12-01
• First posted: 2016-08-18
• Last updated: 2016-08-25