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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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