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

2016-01-24 16:20:47 | BioPortfolio

Summary

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

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"

Study Design

Time Perspective: Cross-Sectional

Conditions

Opioid-Related Disorders

Intervention

Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)

Status

Active, not recruiting

Source

Member Companies of the Opioid PMR Consortium

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-01-24T16:20:47-0500

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