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

Mild to Heavy Alcohol Consumption Clinical Trial

— CAAP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02945293
• Other study ID #: STUDY00001018
• Secondary ID: 5R01AG047979
• Status: Active, not recruiting
• Start date: November 2015
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: September 1, 2021
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Mild to Heavy Alcohol Consumption

Intervention

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

Locations

Country	Name	City	State
United States	Univ. of Washington Medical Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute on Aging (NIA), National Institutes of Health (NIH), Seattle Institute for Biomedical and Clinical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to a pain stimulus	Exposure to cold water, followed by exposure to warm water	given during study day
Secondary	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)
Secondary	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)
Secondary	Pupil size	measure of pupil diameter in millimeters	Study day visit (9-10 hours long)
Secondary	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)