Opioid-Related DisordersNCT02660619
Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication
An observational study of Opioid-Related Disorders and Opiate Addiction, run by Member Companies of the Opioid PMR Consortium.
Trial summary
The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse
- What is being tested?
- Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)
- How many people
- 606 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2015to 28 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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"
Who cannot join
- 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.
About this study
The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.
Read the 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"
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)
- Medical subject headings
- Opioid-Related Disorders, Narcotic-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)Other
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 14 days (reliability determined by re-interviews 1-14 days after first interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study start17 Nov 2015
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Member Companies of the Opioid PMR Consortium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Research Foundation for Mental Hygiene, Inc., Columbia University
- Responsible party
- Sponsor
- Investigators
- Kenneth R Petronis, Study chair, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660619
- Sponsor's protocol ID
- Observational Study 3033-5
- Other IDs
- Study 3033-5
- Status last verified
- Jun 2020
- First submitted
- 14 Jan 2016
- Last updated
- 16 Jun 2020
- Results posted
- No
Publications
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.
PubMed 35702830
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication
- ClinicalTrials.gov ID
- NCT02660619
- Acronym / sponsor ID
- Observational Study 3033-5
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Member Companies of the Opioid PMR ConsortiumIndustry (pharma, biotech, devices)
- Collaborators
- Research Foundation for Mental Hygiene, Inc., Columbia University
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-risk patients | – | Other: Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)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 |
| High-risk patients | – | Other: Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)These patients will be in treatment for addiction to opioids and have (or have had) a prescription of opioids to treat pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op) | Other | High-risk patients, Low-risk patients |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 35702830Hasin 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth R Petronis study chair
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-Related Disorders and Opiate Addiction, run by Member Companies of the Opioid PMR Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.