Opioid-Related Disorders Clinical Trial
Official title:
Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication
The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.
"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"
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