Mild to Heavy Alcohol Consumption Clinical Trial
— CAAPOfficial title:
Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
| Verified date | May 2021 |
| Source | University of Washington |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.
| Status | Active, not recruiting |
| Enrollment | 128 |
| Est. completion date | September 1, 2021 |
| Est. primary completion date | October 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 35 Years and older |
| Eligibility | Inclusion Criteria: - Age of 35 years old or above - Mild to moderate pain - alcohol consumption - 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 - Cigarette smokers must be willing to refrain from smoking during the all day study visit Exclusion Criteria: - current regular use of an opioid or medications that involve the opioid receptor (naltrexone (vivitrol), buprenorphine (subutex), methadone (dolophine) - abstains from alcohol - 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 - Diagnosis of schizophrenia or schizoaffective disorder, or anxiety disorder requiring regular medication - History of recreational drug use in the past 1 year, excluding marijuana - 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 - Medications that may alter oxycodone metabolism: St. John's wort, Dilantin, tegretol, corticosteroids, rifampin - Known hypersensitivity to oxycodone and other opioids; - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| United States | Univ. of Washington Medical Center | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington | National Institute on Aging (NIA), National Institutes of Health (NIH), Seattle Institute for Biomedical and Clinical Research |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | response to a pain stimulus | Exposure to cold water, followed by exposure to warm water | given during study day | |
| Secondary | 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) | |
| Secondary | functional measure of balance modified berg balance test | score on a functional questionnaire (0 - 30) | Screening visit (3 hours long) and study day visit (9-10 hours long) | |
| Secondary | Pupil size | measure of pupil diameter in millimeters | Study day visit (9-10 hours long) | |
| Secondary | 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) |