Drug Abuse, Narcotic Abuse, Opiate Addiction, Opioid-Related Disorders
Conditions
Brief 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
Interventions
OTHERPsychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)
Sponsors
Research Foundation for Mental Hygiene, Inc.
Columbia University
Member Companies of the Opioid PMR Consortium
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnoses of Addiction to Prescription Opioids via PRISM-5-Op | Up to 14 days (reliability determined by re-interviews 1-14 days after first interview) | 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). |
Outcome results
None listed