Mild to Heavy Alcohol Consumption
Conditions
Keywords
Pain, Elderly, Aged, Opioid, Cognition, Side-effects, Alcohol, Alcohol Use Disorder (AUD), Older
Brief summary
The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.
Detailed description
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.
Interventions
OTHEROxycodone
This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Seattle Institute for Biomedical and Clinical Research
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response to a pain stimulus | given during study day | Exposure to cold water, followed by exposure to warm water |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| medication impact , opioid adjective checklist | Study day visit (9-10 hours long) | adjective questionnaire on the impact of study medication scale of 0 t0 4 on likert scale |
| functional measure of balance modified berg balance test | Screening visit (3 hours long) and study day visit (9-10 hours long) | score on a functional questionnaire (0 - 30) |
| Pupil size | Study day visit (9-10 hours long) | measure of pupil diameter in millimeters |
| verbal memory performance on list learning task | Study day visit (9-10 hours long) | immediate and delayed recall of a list of words (score of 0 - 45) |
Countries
United States
Outcome results
None listed