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

Member Companies of the Opioid PMR Consortium606 enrolled

Overview

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"

Study Type

OBSERVATIONAL

Enrollment

606

Conditions

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Has or has had a prescription for opioids for chronic pain for at least 30 days 2. Age 18 years or older and English-speaking 3. Willing and able to provide informed consent" Exclusion Criteria: 1. Patient has a hearing or vision impairment that would preclude an interview or completion of self-administered questionnaires 2. Patient too cognitively impaired to give informed consent or participate in the evaluations.

Outcomes

Primary Outcomes

Diagnoses of Addiction to Prescription Opioids via PRISM-5-Op

PRISM-5-Op diagnoses of DSM-5 SUD/addiction to prescription opioids. These diagnoses will be in two forms: unadjusted, meaning that the criteria will be rated positive if present without regard to the intent of the behavior, and adjusted, i.e., that criteria will be rated positive only if structured evaluation indicates that they represent addiction indicators (non-therapeutic intent) rather than treatment of pain (therapeutic intent).

Time frame: Up to 14 days (reliability determined by re-interviews 1-14 days after first interview)

Data from ClinicalTrials.gov

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