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

University of Washington

Status: Unknown

Conditions: Mild to Heavy Alcohol Consumption

Treatments: Other: Oxycodone

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02945293

STUDY00001018

5R01AG047979 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

128 participants in 1 patient group

Study Procedures

Description:

Study procedures include a screening visit, a study day visit, and a follow-up phone call. Oxycodone is administered on the study day.

Treatment:

Other: Oxycodone