A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

April 14, 2020 updated by: Member Companies of the Opioid PMR Consortium

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients within the Department of Defense (DoD)/TriCare health system with chronic (>3 months) pain treated with opioids.

Description

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Diagnosed chronic pain (≥ 3 months) condition which requires long-term treatment with opioids;
  3. Willingness to provide written informed consent; and
  4. Able to participate in and complete an Internet-based survey and a telephone interview in English.

Exclusion Criteria:

  1. 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
  2. Terminal illness with life expectancy <6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with chronic pain on opioids
Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

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

This is where you will find people and organizations involved with this study.

Sponsor

Member Companies of the Opioid PMR Consortium

Collaborators

Evidera

Investigators

  • Study Chair: Alexandra Barsdorf, Ph.D., Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2015

Primary Completion (Actual)

June 21, 2017

Study Completion (Actual)

June 21, 2017

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

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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