NCT02660619

Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 606 (actual)
• Sponsor: Member Companies of the Opioid PMR Consortium · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.

Detailed description

"Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The present study, PMR Study #2065-2, focuses on addiction, and addresses the FDA requirement to conduct a validation study of the measure of addiction that will be used in PMR Study #2065-1. The primary objective for Study 2b is to validate PRISM-5-Op measures of DSM-5 prescription opioid SUD/addiction in patients who have, or have had, a prescription for opioids for at least 30 days to treat chronic pain"

Conditions

• Opioid-Related Disorders
• Opiate Addiction
• Narcotic Abuse
• Drug Abuse

Interventions

Type	Name	Description
OTHER	Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)

Timeline

• Start date: 2015-11-17
• Primary completion: 2017-11-28
• Completion: 2017-11-28
• First posted: 2016-01-21
• Last updated: 2020-06-16