Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT02945293
Status:
UNKNOWN
Last Update Posted:
2021-05-13
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-09-17', 'releaseDate': '2021-08-23'}], 'estimatedResultsFirstSubmitDate': '2021-08-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-25', 'size': 163691, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-15T12:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, blood plasma, isolated DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response to a pain stimulus', 'timeFrame': 'given during study day', 'description': 'Exposure to cold water, followed by exposure to warm water'}], 'secondaryOutcomes': [{'measure': 'medication impact , opioid adjective checklist', 'timeFrame': 'Study day visit (9-10 hours long)', 'description': 'adjective questionnaire on the impact of study medication scale of 0 t0 4 on likert scale'}, {'measure': 'functional measure of balance modified berg balance test', 'timeFrame': 'Screening visit (3 hours long) and study day visit (9-10 hours long)', 'description': 'score on a functional questionnaire (0 - 30)'}, {'measure': 'Pupil size', 'timeFrame': 'Study day visit (9-10 hours long)', 'description': 'measure of pupil diameter in millimeters'}, {'measure': 'verbal memory performance on list learning task', 'timeFrame': 'Study day visit (9-10 hours long)', 'description': 'immediate and delayed recall of a list of words (score of 0 - 45)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain', 'Elderly', 'Aged', 'Opioid', 'Cognition', 'Side-effects', 'Alcohol', 'Alcohol Use Disorder (AUD)', 'Older'], 'conditions': ['Mild to Heavy Alcohol Consumption']}, 'referencesModule': {'references': [{'pmid': '19729346', 'type': 'BACKGROUND', 'citation': 'Cherrier MM, Amory JK, Ersek M, Risler L, Shen DD. Comparative cognitive and subjective side effects of immediate-release oxycodone in healthy middle-aged and older adults. J Pain. 2009 Oct;10(10):1038-50. doi: 10.1016/j.jpain.2009.03.017. Epub 2009 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.', 'detailedDescription': 'Potential participants complete a phone screen. If still found eligible, the participant comes in for 1 screening visit (3 hours long). Cognitive/problem solving tests, computerized tasks, CPT, questionnaires and functional measures are administered along with a screening blood lab. If a participant is eligible, he/she comes back for 1 full study day visit (9-10 hours long). A testing battery (similar to the one done during the screening visit) is completed at baseline and again at three timepoints following medication administration. Blood draws, vital signs, and pupil measurements are taken throughout the day. A follow-up phone call is completed within a few days of the full study day visit, during which a questionnaire is given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community dwelling participants in the greater Puget Sound region (Seattle and Tacoma) who consume alcohol on a frequent basis', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age of 35 years old or above\n* Mild to moderate pain\n* alcohol consumption\n* willingness to refrain from taking any sort of pain medication 24 hours prior to study visit as well as refraining from taking sedative-hypnotics, antihistamines, benzodiazepines, sleep aids, NSAIDs/opioid pain medications, alcohol, marijuana\n* Cigarette smokers must be willing to refrain from smoking during the all day study visit\n\nExclusion Criteria:\n\n* current regular use of an opioid or medications that involve the opioid receptor (naltrexone (vivitrol), buprenorphine (subutex), methadone (dolophine)\n* abstains from alcohol\n* unstable angina or CHF; cerebral vascular accident or recurrent TIAs in the prior 6 months, active cancer requiring current treatment, possible or probable dementia or mild cognitive impairment\n* Diagnosis of schizophrenia or schizoaffective disorder, or anxiety disorder requiring regular medication\n* History of recreational drug use in the past 1 year, excluding marijuana\n* New or increased dose (within last 6 months) of CNS-active medications that may alter neurocognitive and/or psychomotor function: MAO inhibitors, neuroleptics, antidepressants, anticonvulsants, benzodiazepines, sleep aids\n* Medications that may alter oxycodone metabolism: St. John's wort, Dilantin, tegretol, corticosteroids, rifampin\n* Known hypersensitivity to oxycodone and other opioids;\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT02945293', 'acronym': 'CAAP', 'briefTitle': 'Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users', 'orgStudyIdInfo': {'id': 'STUDY00001018'}, 'secondaryIdInfos': [{'id': '5R01AG047979', 'link': 'https://reporter.nih.gov/quickSearch/5R01AG047979', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Procedures', 'description': 'Study procedures include a screening visit, a study day visit, and a follow-up phone call. Oxycodone is administered on the study day.', 'interventionNames': ['Other: Oxycodone']}], 'interventions': [{'name': 'Oxycodone', 'type': 'OTHER', 'description': 'This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed', 'armGroupLabels': ['Study Procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Univ. of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Monique M. Cherrier, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'upon completion of the study a copy of information will be made available on the open science framework site', 'ipdSharing': 'YES', 'description': 'For data obtained at UofW- a de-identified version can be made available upon request for data obtained at VAPSHCS IRB ISO, and PO do not allow the sharing of data, even de-identified data with other investigators- if VA regulations allow data sharing, then the investigators will be allowed to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Seattle Institute for Biomedical and Clinical Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Medicine: Psychiatry And Behavioral Sciences', 'investigatorFullName': 'Monique Cherrier', 'investigatorAffiliation': 'University of Washington'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-08-23', 'type': 'RELEASE'}, {'date': '2021-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Monique Cherrier, Associate Professor, School of Medicine: Psychiatry And Behavioral Sciences, University of Washington'}}}}