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

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ClinicalTrials.gov Identifier: NCT02945293
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Seattle Institute for Biomedical and Clinical Research
Information provided by (Responsible Party):
Monique Cherrier, 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.

Condition or disease Intervention/treatment Phase
Mild to Heavy Alcohol Consumption Other: Oxycodone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
Study Start Date : November 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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




Primary Outcome Measures :
  1. response to a pain stimulus [ Time Frame: given during study day ]
    Exposure to cold water, followed by exposure to warm water


Secondary Outcome Measures :
  1. medication impact , opioid adjective checklist [ Time Frame: Study day visit (9-10 hours long) ]
    adjective questionnaire on the impact of study medication scale of 0 t0 4 on likert scale

  2. functional measure of balance modified berg balance test [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
    score on a functional questionnaire (0 - 30)

  3. Pupil size [ Time Frame: Study day visit (9-10 hours long) ]
    measure of pupil diameter in millimeters

  4. verbal memory performance on list learning task [ Time Frame: Study day visit (9-10 hours long) ]
    immediate and delayed recall of a list of words (score of 0 - 45)



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945293


Contacts
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Contact: Reba Blissel, B.S. 206.616.3075 caap@uw.edu
Contact: Colton Kray 206.616.3075 caap@uw.edu

Locations
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United States, Washington
Univ. of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Reba Blissel    206-616-3075    caap@uw.edu   
Contact: Colton Kray    206.616.3075    caap@uw.edu   
Principal Investigator: Monique M. Cherrier, Ph.D.         
Sub-Investigator: Greg Terman, M.D.         
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Seattle Institute for Biomedical and Clinical Research
Investigators
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Principal Investigator: Monique M. Cherrier, Ph.D. University of Washington

Publications:
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Responsible Party: Monique Cherrier, Associate Professor, School of Medicine: Psychiatry And Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT02945293     History of Changes
Other Study ID Numbers: STUDY00001018
5R01AG047979 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: For data obtained at UofW- a de-identified version can be made available upon request for data obtained at VAPSHCS IRB ISO, and PO do not allow the sharing of data, even de-identified data with other investigators- if VA regulations allow data sharing, then the investigators will be allowed to share data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: upon completion of the study a copy of information will be made available on the open science framework site

Keywords provided by Monique Cherrier, University of Washington:
Pain
Elderly
Aged
Opioid
Cognition
Side-effects
Alcohol
Alcohol Use Disorder (AUD)
Older

Additional relevant MeSH terms:
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Oxycodone
Alcohol Drinking
Drinking Behavior
Ethanol
Analgesics
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Sensory System Agents
Peripheral Nervous System Agents