Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users

Conditions
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Mild to Heavy Alcohol Consumption

Intervention / Treatment
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* Other: Oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Procedures<br>Study procedures include a screening visit, a study day visit, and a follow-up phone call. Oxycodone is administered on the study day. | Other: Oxycodone<br>* This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to a pain stimulus | Exposure to cold water, followed by exposure to warm water | given during study day | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Elderly, Aged, Opioid, Cognition, Side-effects, Alcohol, Alcohol Use Disorder (AUD), Older