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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG047979 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
| Seattle Institute for Biomedical and Clinical Research | OTHER |
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The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Procedures | Study procedures include a screening visit, a study day visit, and a follow-up phone call. Oxycodone is administered on the study day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Other | This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed |
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| Measure | Description | Time Frame |
|---|---|---|
| response to a pain stimulus | Exposure to cold water, followed by exposure to warm water | given during study day |
| Measure | Description | Time Frame |
|---|---|---|
| medication impact , opioid adjective checklist | adjective questionnaire on the impact of study medication scale of 0 t0 4 on likert scale | Study day visit (9-10 hours long) |
| functional measure of balance modified berg balance test |
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Inclusion Criteria:
Exclusion Criteria:
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community dwelling participants in the greater Puget Sound region (Seattle and Tacoma) who consume alcohol on a frequent basis
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| Name | Affiliation | Role |
|---|---|---|
| Monique M. Cherrier, Ph.D. | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. of Washington Medical Center | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19729346 | Background | 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. |
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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
upon completion of the study a copy of information will be made available on the open science framework site
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 23, 2021 | |
| Reset | Sep 17, 2021 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2017 | Jun 15, 2020 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 23, 2021 | Sep 17, 2021 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Whole blood, blood plasma, isolated DNA
score on a functional questionnaire (0 - 30)
| Screening visit (3 hours long) and study day visit (9-10 hours long) |
| Pupil size | measure of pupil diameter in millimeters | Study day visit (9-10 hours long) |
| verbal memory performance on list learning task | immediate and delayed recall of a list of words (score of 0 - 45) | Study day visit (9-10 hours long) |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |