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

Completed

• Conditions: Opiate Addiction; Narcotic Abuse; Opioid-Related Disorders; Drug Abuse
• Interventions: Other: Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)

• Registration Number: NCT02660619
• Lead Sponsor: Member Companies of the Opioid PMR Consortium

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"

Study Timeline

• Study Start: 2015-11-17
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-18
• Study First Posted: 2016-01-21
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 606

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-risk patients	Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)	These patients will be in treatment for addiction to opioids and have (or have had) a prescription of opioids to treat pain.
Low-risk patients	Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)	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

Primary Outcome Measures

Name	Time	Method
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).