Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
- Conditions
- Mild to Heavy Alcohol Consumption
- Interventions
- Other: Oxycodone
- Registration Number
- NCT02945293
- Lead Sponsor
- University of Washington
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Procedures Oxycodone Study procedures include a screening visit, a study day visit, and a follow-up phone call. Oxycodone is administered on the study day.
- Primary Outcome Measures
Name Time Method response to a pain stimulus given during study day Exposure to cold water, followed by exposure to warm water
- Secondary Outcome Measures
Name Time Method 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
Pupil size Study day visit (9-10 hours long) measure of pupil diameter in millimeters
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)
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)
Trial Locations
- Locations (1)
Univ. of Washington Medical Center
🇺🇸Seattle, Washington, United States