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| ID | Type | Description | Link |
|---|---|---|---|
| Study 3033-5 | Other Identifier | Member Companies of the Opioid PMR Consortium |
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| Name | Class |
|---|---|
| Research Foundation for Mental Hygiene, Inc. | OTHER |
| Columbia University | OTHER |
The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.
"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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op) | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth R Petronis | Pfizer | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35702830 | Derived | 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. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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