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OpenTrials
Completed

NCT Number: NCT04223609

Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

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.

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Key information

Conditions

Healthy

Age range

21 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxycodone

Drug

5 mg tablet

Other names: Oxycodone Immediate Release

Placebo

Drug

Oxycodone-matched placebo tablet

EyeLink 1000 Plus

Device

Non-invasive video-based eye tracking system

Other names: EyeLink

Oculo-Cognitive Addition Test (OCAT)

Diagnostic Test

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.

VT3mini - Eye Tracking Technology for OEMs

Device

Non-invasive eye-tracking device

Other names: EyeTech

Primary outcomes

  1. 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.

  2. Saccadic Latency

    Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

    measured in seconds

  3. Fixation Time - Low Cognitive Workload

    Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

    measure in milliseconds

  4. Fixation Time - Medium Cognitive Workload

    Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

    measure in milliseconds

  5. Fixation Time - High Cognitive Workload

    Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

    measure in milliseconds

  6. Diagonal Saccadic Velocity

    Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

    measured in deg/s

  7. Horizontal Saccadic Velocity

    Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

    measured in deg/s

  8. Vertical Saccadic Velocity

    Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

    measured in deg/s

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2020
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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