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

NCT02660619 | Completed

• 2 other identifiers: Observational Study 3033-5Study 3033-5
• Study Type: observational
• Target: 606
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

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

Study Arms (2)

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)

Interventions

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

High-risk patients; Low-risk patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Has or has had a prescription for opioids for chronic pain for at least 30 days
• Age 18 years or older and English-speaking
• Willing and able to provide informed consent"

You may not qualify if:

• Patient has a hearing or vision impairment that would preclude an interview or completion of self-administered questionnaires
• Patient too cognitively impaired to give informed consent or participate in the evaluations.

Sponsors & Collaborators

• Member Companies of the Opioid PMR Consortium: lead
• Research Foundation for Mental Hygiene, Inc.: collaborator
• Columbia University: collaborator

Related Publications (1)

• Hasin DS, Shmulewitz D, Stohl M, Greenstein E, Aharonovich E, Petronis KR, Von Korff M, Datta S, Sonty N, Ross S, Inturrisi C, Weinberger ML, Scodes J, Wall MM. Diagnosing Prescription Opioid Use Disorder in Patients Using Prescribed Opioids for Chronic Pain. Am J Psychiatry. 2022 Oct;179(10):715-725. doi: 10.1176/appi.ajp.21070721. Epub 2022 Jun 15.

  PMID: 35702830 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kenneth R Petronis

  Pfizer

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 21, 2016
• Study Start: November 17, 2015
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: June 16, 2020

Record last verified: 2020-06