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

June 15, 2020 updated by: Member Companies of the Opioid PMR Consortium
The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from low-risk and high-risk treatment settings in the greater New York City metropolitan area, which includes the five boroughs of the city and Long Island. Thus, the population will be a mix of urban and suburban participants.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnoses of Addiction to Prescription Opioids via PRISM-5-Op
Time Frame: 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).
Up to 14 days (reliability determined by re-interviews 1-14 days after first interview)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Member Companies of the Opioid PMR Consortium

Collaborators

Columbia University
Research Foundation for Mental Hygiene, Inc.

Investigators

  • Study Chair: Kenneth R Petronis, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2015

Primary Completion (Actual)

November 28, 2017

Study Completion (Actual)

November 28, 2017

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 18, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Observational Study 3033-5
  • Study 3033-5 (Other Identifier: Member Companies of the Opioid PMR Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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