Opioid-Related DisordersPOMAQNCT02678507
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire
An observational study of Opioid-Related Disorders and Opiate Addiction, run by Member Companies of the Opioid PMR Consortium.
Trial summary
The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use. 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?
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2015to 21 Jun 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 within the Department of Defense (DoD)/TriCare health system with chronic (>3 months) pain treated with opioids.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.
Read the 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.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- 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.
Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)Other
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic pain on opioids | Not described Receives: Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification Validity of the POMAQ in misuse and abuse of prescription opioid behaviors
Measured: Single Survey, with re-test in 20% of population 7-10 days after initial completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start7 Apr 2015
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Member Companies of the Opioid PMR Consortium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidera
- Responsible party
- Sponsor
- Investigators
- Alexandra Barsdorf, Ph.D., Study chair, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678507
- Sponsor's protocol ID
- Observational Study 3033-4
- Other IDs
- 3033-4
- Acronym
- POMAQ
- Status last verified
- Apr 2020
- First submitted
- 5 Feb 2016
- Last updated
- 15 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- ClinicalTrials.gov ID
- NCT02678507
- Acronym / sponsor ID
- POMAQ / Observational Study 3033-4
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Member Companies of the Opioid PMR ConsortiumIndustry (pharma, biotech, devices)
- Collaborators
- Evidera
- Study start
- 7 Apr 2015 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 9 Feb 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 purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic pain on opioids | – | Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients within the Department of Defense (DoD)/TriCare health system with chronic (>3 months) pain treated with opioids.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) | Other | Patients with chronic pain on opioids |
Primary outcome
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
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 15 Apr 2020.
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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.
Alexandra Barsdorf, Ph.D. 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 4 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 15 Apr 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2020.