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

NCT02945293 | Unknown DMC

• 2 other identifiers: STUDY000010185R01AG047979
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Heavy Alcohol Consumption

Keywords

Pain; Elderly; Aged; Opioid; Cognition; Side-effects; Alcohol; Alcohol Use Disorder (AUD); Older

Outcome Measures

Primary Outcomes (1)

• response to a pain stimulus

  Exposure to cold water, followed by exposure to warm water

  given during study day

Secondary Outcomes (4)

• medication impact , opioid adjective checklist

  Study day visit (9-10 hours long)

• functional measure of balance modified berg balance test

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

• Pupil size

  Study day visit (9-10 hours long)

• verbal memory performance on list learning task

  Study day visit (9-10 hours long)

Study Arms (1)

Study Procedures

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

Other: Oxycodone

Interventions

Oxycodone OTHER

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

Study Procedures

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator
• Seattle Institute for Biomedical and Clinical Research: collaborator

Study Sites (1)

Univ. of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related 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.

  PMID: 19729346 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, blood plasma, isolated DNA

MeSH Terms

Conditions

Pain; Alcoholism

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Monique M. Cherrier, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Psychiatry And Behavioral Sciences

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 26, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: September 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: upon completion of the study a copy of information will be made available on the open science framework site

Locations

US (1)