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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

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE October 26, 2016
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
response to a pain stimulus [ Time Frame: given during study day ]
Exposure to cold water, followed by exposure to warm water
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
Cold Pressor Test (CPT) [ Time Frame: given during study day ]
Exposure to cold water, followed by exposure to warm water
Change History Complete list of historical versions of study NCT02945293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
  • 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
  • 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)
  • Pupil size [ Time Frame: Study day visit (9-10 hours long) ]
    measure of pupil diameter in millimeters
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • Assessment of side effects [ Time Frame: Study day visit (9-10 hours long) ]
    Questionnaire given to assess Oxycodone side effects
  • Assessment of cognitive functioning: Verbal memory task (number of words recalled from list) [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
  • Digit span task (number correct across trials) [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
  • D2 Test (total number correct across trials) [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
  • Letter Number Sequencing (total number correct across trials) [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
  • Assessment of balance: Berg Balance Scale (total correct) [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
  • Assessment of psychomotor coordination (milliseconds) [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
  • Pupil size measurement: Pupilometer (millimeters) [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
    Average of three measurements to assess pupil dilation
  • Blood pressure [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
  • O2 Saturation [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
  • Respiratory rate [ Time Frame: Screening visit (3 hours long) and study day visit (9-10 hours long) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
Official Title  ICMJE Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Mild to Heavy Alcohol Consumption
Intervention  ICMJE Other: Oxycodone
This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed
Study Arms  ICMJE 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.
Intervention: Other: Oxycodone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2017)
160
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2016)
120
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Reba Blissel, B.S. 206.616.3075 caap@uw.edu
Contact: Colton Kray 206.616.3075 caap@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02945293
Other Study ID Numbers  ICMJE STUDY00001018
5R01AG047979 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party Monique Cherrier, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)
  • Seattle Institute for Biomedical and Clinical Research
Investigators  ICMJE
Principal Investigator: Monique M. Cherrier, Ph.D. University of Washington
PRS Account University of Washington
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP