Clinical trial NCT02945293: Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
Official title: Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild to Heavy Alcohol Consumption
Keywords: Pain
Elderly
Aged
Opioid
Cognition
Side-effects
Alcohol
Alcohol Use Disorder (AUD)
Older
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
name: Seattle Institute for Biomedical and Clinical Research
First posted: 2016-10-26
Enrollment: 128
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community dwelling participants in the greater Puget Sound region (Seattle and Tacoma) who consume alcohol on a frequent basis

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.

Eligibility criteria: 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

Primary outcomes:
measure: response to a pain stimulus
timeFrame: given during study day
Secondary outcomes:
measure: medication impact , opioid adjective checklist
timeFrame: Study day visit (9-10 hours long)
measure: functional measure of balance modified berg balance test
timeFrame: Screening visit (3 hours long) and study day visit (9-10 hours long)
measure: Pupil size
timeFrame: Study day visit (9-10 hours long)
measure: verbal memory performance on list learning task
timeFrame: Study day visit (9-10 hours long)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Univ. of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Monique M. Cherrier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cherrier MM, Amory JK, Ersek M, Risler L, Shen DD. Comparative cognitive and subjective side effects of immediate-release oxycodone in healthy middle-aged and older adults. J Pain. 2009 Oct;10(10):1038-50. doi: 10.1016/j.jpain.2009.03.017. Epub 2009 Sep 2.