Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

March 13, 2023 updated by: Gaurav N. Pradhan, Mayo Clinic
Research is being conducted to better understand the physiologic effects (relating to the action of a drug when taken by a healthy person) of opioid use on oculomotor (relating to the motion of the eye) dynamics and to identify the presence of characteristics consistent with a specific drug or class of drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be able to consent to participate themselves
  • Be healthy male or non-pregnant female
  • Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
  • Have not used opioids during the preceding 30 days
  • Prior use of opioids for pain management

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • Women who are not practicing an effective form of contraception (condoms, IUD, birth control pill, diaphragm),
  • Past or current history of drug or substance use.
  • Significant ocular disorder.
  • Positive drug test for marijuana, opioids, methamphetamines, cocaine, PCP or other controlled substances.
  • History of use of psychoactive drugs within the past 30 days.
  • Subjects with a history of cardiopulmonary disease including but not limited to congestive heart failure, obstructive sleep apnea, restrictive lung disease, COPD, moderate to severe asthma and oxygen dependency.
  • Subjects currently taking sedatives (including benzodiazepines), muscle relaxants or disassociatives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxycodone, Then Placebo
Participants first receive initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with placebo.
Drug: Oxycodone
5 mg tablet
Other Names:
  • Oxycodone Immediate Release
Drug: Placebo
Oxycodone-matched placebo tablet
Device: EyeLink 1000 Plus
Non-invasive video-based eye tracking system
Other Names:
  • EyeLink
Diagnostic test: Oculo-Cognitive Addition test (OCAT)
Subject will have to look for numbers on a screen and add these numbers together. OCAT will be presented on a computer screen with attached eye tracking device at the bottom part.
Device: VT3mini - Eye Tracking Technology for OEMs
Non-invasive eye-tracking device
Other Names:
  • EyeTech
Experimental: Placebo, Then Oxycodone
Participants first receive initial dose of placebo 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a set of standardized oculomotor testing for 40 minutes. After the initial testing, a second dose of placebo 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with oxycodone.
Drug: Oxycodone
5 mg tablet
Other Names:
  • Oxycodone Immediate Release
Drug: Placebo
Oxycodone-matched placebo tablet
Device: EyeLink 1000 Plus
Non-invasive video-based eye tracking system
Other Names:
  • EyeLink
Diagnostic test: Oculo-Cognitive Addition test (OCAT)
Subject will have to look for numbers on a screen and add these numbers together. OCAT will be presented on a computer screen with attached eye tracking device at the bottom part.
Device: VT3mini - Eye Tracking Technology for OEMs
Non-invasive eye-tracking device
Other Names:
  • EyeTech

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oculo-Cognitive Addition Test (OCAT) Completion Time
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Time it takes participants to complete the OCAT measured in seconds.
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Saccadic Latency
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in seconds
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Fixation Time - Low Cognitive Workload
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Fixation Time - Medium Cognitive Workload
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Fixation Time - High Cognitive Workload
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Diagonal Saccadic Velocity
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Horizontal Saccadic Velocity
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Vertical Saccadic Velocity
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Gaurav Pradhan, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Actual)

April 11, 2022

Study Completion (Actual)

April 11, 2022

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-004883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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