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

University of Washington128 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

128

Conditions

Mild to Heavy Alcohol Consumption

Interventions

OxycodoneOTHER

This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed

Eligibility

Sex: ALLMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Univ. of Washington Medical Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

response to a pain stimulus

Exposure to cold water, followed by exposure to warm water

Time frame: given during study day

Secondary Outcomes

medication impact , opioid adjective checklist

adjective questionnaire on the impact of study medication scale of 0 t0 4 on likert scale

Time frame: Study day visit (9-10 hours long)

functional measure of balance modified berg balance test

score on a functional questionnaire (0 - 30)

Time frame: Screening visit (3 hours long) and study day visit (9-10 hours long)

Pupil size

measure of pupil diameter in millimeters

Time frame: 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)

Time frame: Study day visit (9-10 hours long)

Data from ClinicalTrials.gov

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