Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02660606
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2016-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2016-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2016-01-14', 'studyFirstSubmitQcDate': '2016-01-18', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Content validity of POMAQ', 'timeFrame': 'Day 1, based upon survey completed at single visit', 'description': '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'}]}, 'conditionsModule': {'conditions': ['Opioid-Related Disorders', 'Opiate Addiction', 'Narcotic Abuse', 'Drug Abuse']}, 'referencesModule': {'references': [{'pmid': '35437075', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nCurrently, 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).\n\nThis 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic pain recruited from primary care or chronic pain clinics', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients who, based on the Site Investigator's clinical judgment, have chronic moderate to severe pain\n3. Willing to provide written informed consent\n4. Able to participate in a one-on-one interview\n5. Able to read, speak, and understand English and complete all study assessments.\n\nExclusion Criteria:\n\n1. Cognitive, psychiatric or other impairment based on the Site Investigator's clinical judgment that would interfere with participating in a one-on-one discussion\n2. Terminal illness with life expectancy \\< 6 months."}, 'identificationModule': {'nctId': 'NCT02660606', 'acronym': 'POMAQ', 'briefTitle': 'A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire', 'organization': {'class': 'INDUSTRY', 'fullName': 'Member Companies of the Opioid PMR Consortium'}, 'officialTitle': 'A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)', 'orgStudyIdInfo': {'id': 'Observational Study 3033-3'}, 'secondaryIdInfos': [{'id': '3033-3', 'type': 'OTHER', 'domain': 'Member Companies of the Opioid PMR Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Opioid abusers', 'interventionNames': ['Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)']}, {'label': 'Group 2: Abusers of other substances', 'interventionNames': ['Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)']}, {'label': 'Group 3: Non-opioid abusers', 'interventionNames': ['Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)']}, {'label': 'Group 4: Non-opioid users', 'interventionNames': ['Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)']}], 'interventions': [{'name': 'Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)', 'type': 'OTHER', 'armGroupLabels': ['Group 1: Opioid abusers', 'Group 2: Abusers of other substances', 'Group 3: Non-opioid abusers', 'Group 4: Non-opioid users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Evidera', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Alexandra Barsdorf, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Member Companies of the Opioid PMR Consortium', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Evidera', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}