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

Member Companies of the Opioid PMR Consortium

Status: Completed

Conditions: Opiate Addiction; Opioid-Related Disorders; Drug Abuse; Narcotic Abuse

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02660619

Observational Study 3033-5

Study 3033-5 (Other Identifier)

Details and patient eligibility

About

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

Full 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"

Enrollment: 606 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

606 participants in 2 patient groups

Low-risk patients

Description:

These will be patients with a prescription for opioids for chronic pain for at least 30 days, recruited from university-affiliated pain and rehabilitation medicine clinics that routinely employ precautions to avoid prescribing such medication to individuals seeking it for non-therapeutic reasons

Treatment:

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

High-risk patients

Description:

These patients will be in treatment for addiction to opioids and have (or have had) a prescription of opioids to treat pain.

Treatment:

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