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

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ClinicalTrials.gov Identifier: NCT02660619
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
Columbia University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Opioid-Related Disorders Opiate Addiction Narcotic Abuse Drug Abuse Other: Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)

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"

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Study Type : Observational
Actual Enrollment : 606 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication
Actual Study Start Date : November 17, 2015
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660619


Sponsors and Collaborators
Member Companies of the Opioid PMR Consortium
Research Foundation for Mental Hygiene, Inc.
Columbia University
Investigators
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Study Chair: Kenneth R Petronis Pfizer
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Responsible Party: Member Companies of the Opioid PMR Consortium
ClinicalTrials.gov Identifier: NCT02660619    
Other Study ID Numbers: Observational Study 3033-5
Study 3033-5 ( Other Identifier: Member Companies of the Opioid PMR Consortium )
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Narcotic-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders