Opioid-Related DisordersPOMAQNCT02660606
A Qualitative Study to Assess the Content 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 at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users 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
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2015to 18 Jan 2016
- 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 with chronic pain recruited from primary care or chronic pain clinics
Who may be able to join
- Age ≥ 18 years
- Patients who, based on the Site Investigator's clinical judgment, have chronic moderate to severe pain
- Willing to provide written informed consent
- Able to participate in a one-on-one interview
- Able to read, speak, and understand English and complete all study assessments.
Who cannot join
- Cognitive, psychiatric or other impairment based on the Site Investigator's clinical judgment that would interfere with participating in a one-on-one discussion
- Terminal illness with life expectancy < 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users
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.
Currently, no tool exists to meet this need except for the Self-report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of prior content validation. The SR-MAD has been 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).
This study will seek to further develop and validate the POMAQ using the the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) as a reference for conducting qualitative research throughout the process of instrument development to ensure the content validity of a measure and to evaluate the comprehensibility of included questions. This qualitative study to evaluate content validity will be conducted prior to the quantitative study to evaluate construct validity
- 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 |
|---|---|---|
| Group 1: Opioid abusers | Not described Receives: Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) | |
| Group 2: Abusers of other substances | Not described Receives: Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) | |
| Group 3: Non-opioid abusers | Not described Receives: Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) | |
| Group 4: Non-opioid users | 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.
Content validity of POMAQ
Evidence of content validity from patients regarding the interpretation of POMAQ items, ease of completion, the comprehensiveness of instrument, and the appropriateness of the format, response scales, and recall period
Measured: Day 1, based upon survey completed at single visit
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 start2 Jan 2015
- Primary completion18 Jan 2016
- Study completion18 Jan 2016
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 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
- NCT02660606
- Sponsor's protocol ID
- Observational Study 3033-3
- Other IDs
- 3033-3
- Acronym
- POMAQ
- Status last verified
- Apr 2020
- First submitted
- 14 Jan 2016
- Last updated
- 15 Apr 2020
- Results posted
- No
Publications
Coyne KS, Schnoll SH, Butler SF, Barsdorf AI, Currie BM, Maziere JY, Pierson RF, Porter LN, Franks CMJ Jr, Farrar JT. Clinical scoring algorithm for the prescription opioid misuse and abuse questionnaire (POMAQ). Curr Med Res Opin. 2022 Jun;38(6):971-980. doi: 10.1080/03007995.2022.2065139. Epub 2022 May 13.
PubMed 35437075
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 Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- ClinicalTrials.gov ID
- NCT02660606
- Acronym / sponsor ID
- POMAQ / Observational Study 3033-3
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Member Companies of the Opioid PMR ConsortiumIndustry (pharma, biotech, devices)
- Collaborators
- Evidera
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 18 Jan 2016 (actual)
- Study completion
- 18 Jan 2016 (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 of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users
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.
Currently, no tool exists to meet this need except for the Self-report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of prior content validation. The SR-MAD has been 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).
This study will seek to further develop and validate the POMAQ using the the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) as a reference for conducting qualitative research throughout the process of instrument development to ensure the content validity of a measure and to evaluate the comprehensibility of included questions. This qualitative study to evaluate content validity will be conducted prior to the quantitative study to evaluate construct validity
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Opioid abusers | – | Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) |
| Group 2: Abusers of other substances | – | Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) |
| Group 3: Non-opioid abusers | – | Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) |
| Group 4: Non-opioid users | – | 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 with chronic pain recruited from primary care or chronic pain clinics
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patients who, based on the Site Investigator's clinical judgment, have chronic moderate to severe pain
- Willing to provide written informed consent
- Able to participate in a one-on-one interview
- Able to read, speak, and understand English and complete all study assessments.
Key exclusion criteria (2 listed)
- Cognitive, psychiatric or other impairment based on the Site Investigator's clinical judgment that would interfere with participating in a one-on-one discussion
- 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 | Group 1: Opioid abusers, Group 2: Abusers of other substances, Group 3: Non-opioid abusers, Group 4: Non-opioid users |
Primary outcome
Content validity of POMAQ
Time frame: Day 1, based upon survey completed at single visit
Evidence of content validity from patients regarding the interpretation of POMAQ items, ease of completion, the comprehensiveness of instrument, and the appropriateness of the format, response scales, and recall period
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.
- Derived from this study: PubMed 35437075Coyne KS, Schnoll SH, Butler SF, Barsdorf AI, Currie BM, Maziere JY, Pierson RF, Porter LN, Franks CMJ Jr, Farrar JT. Clinical scoring algorithm for the prescription opioid misuse and abuse questionnaire (POMAQ). Curr Med Res Opin. 2022 Jun;38(6):971-980. doi: 10.1080/03007995.2022.2065139. Epub 2022 May 13.
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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
1 site in 1 country: see every site and its status.
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 at 1 site in United States.
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 5 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Content validity of POMAQ (time frame: Day 1, based upon survey completed at single visit). 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 NCT02660606, 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 15 Apr 2020.