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

"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"

Inclusion criteria

• Has or has had a prescription for opioids for chronic pain for at least 30 days
• Age 18 years or older and English-speaking
• Willing and able to provide informed consent"

Exclusion criteria

• Patient has a hearing or vision impairment that would preclude an interview or completion of self-administered questionnaires
• Patient too cognitively impaired to give informed consent or participate in the evaluations.