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

M

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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