- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678507
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
Study Overview
Status
Intervention / Treatment
Detailed Description
The Food and Drug Administration (FDA) has requested, as part of a Post-marketing requirement (PMR) for new drug application (NDA) holders of extended release/long-acting (ER/LA) opioids, to conduct a study to develop and validate a measure of the opioid-related adverse events misuse and abuse among patients with chronic pain prescribed long-term opioid therapy. This measure will be used to assess misuse and abuse in PMR Study 2065-1A and PMR Study 2065-4B.
To date, no tool currently exists to address the needs of the PMR except for the Self-Report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of content validation but requires further validation. The SR-MAD has been substantially modified to meet the needs of PMR Studies 2065-1A and 2065-4B and has been renamed the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). The POMAQ will undergo content validation via qualitative interviews (Protocol 2065-2A [Qualitative]) prior to use in this validation study (Protocol 2065-2A [Quantitative]).
This quantitative study will seek to further develop and validate the POMAQ following the general tenants according to the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) which emphasizes the importance of conducting sound psychometric evaluation of patient-reported instruments through quantitative research methods. However, it should be noted that the POMAQ is not a typical PRO measure capturing a specific latent construct and the specified analytic approach to the POMAQ reflects this difference in theoretical frameworks.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years;
- Diagnosed chronic pain (≥ 3 months) condition which requires long-term treatment with opioids;
- Willingness to provide written informed consent; and
- Able to participate in and complete an Internet-based survey and a telephone interview in English.
Exclusion Criteria:
- Cognitive or other impairment based on the Principal Investigator's judgment that would interfere with the ability of a participant to complete the validation study
- Terminal illness with life expectancy <6 months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with chronic pain on opioids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identification Validity of the POMAQ in misuse and abuse of prescription opioid behaviors
Time Frame: Single Survey, with re-test in 20% of population 7-10 days after initial completion
|
Single Survey, with re-test in 20% of population 7-10 days after initial completion
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Alexandra Barsdorf, Ph.D., Pfizer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Observational Study 3033-4
- 3033-4 (Other Identifier: Member Companies of the Opioid PMR Consortium)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
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Member Companies of the Opioid PMR ConsortiumEvideraCompletedOpioid-Related Disorders | Drug Abuse | Opiate Addiction | Narcotic AbuseUnited States
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ER/LA Opioid REMS Program Companies (RPC)UnknownDrug Abuse | Opioid-related Disorders | Narcotic Abuse | Opioid Addiction
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Member Companies of the Opioid PMR ConsortiumHealthCore, Inc.CompletedOpioid-Related Disorders | Drug Abuse | Opiate Addiction | Narcotic Abuse
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Mclean HospitalUniversity of California, Los AngelesCompletedSubstance-related Disorders | Opioid-related Disorders | Opiate DependenceUnited States
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Centre Hospitalier Universitaire de NīmesWithdrawn
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University of Wisconsin, MadisonCompletedOpioid Use Disorder | Opioid MisuseUnited States
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Queen's UniversityCanadian Institutes of Health Research (CIHR)Completed
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David SheynActive, not recruitingOpioid Use | Post Operative Pain | Prolapse GenitalUnited States
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Member Companies of the Opioid PMR ConsortiumKaiser Permanente; World Health Information Science Consultants, LLCCompletedOpioid-Related Disorders | Drug Abuse | Opiate Addiction | Narcotic Abuse
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Johns Hopkins UniversityThe New York Academy of MedicineCompletedHIV Infections | HIV Seropositivity | Opiate DependenceUnited States