Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2022-04-11

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

5 mg tablet

Placebo

Intervention Type DRUG

Oxycodone-matched placebo tablet

EyeLink 1000 Plus

Intervention Type DEVICE

Non-invasive video-based eye tracking system

Oculo-Cognitive Addition test (OCAT)

Intervention Type 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

Intervention Type DEVICE

Non-invasive eye-tracking device

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.

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

5 mg tablet

Placebo

Intervention Type DRUG

Oxycodone-matched placebo tablet

EyeLink 1000 Plus

Intervention Type DEVICE

Non-invasive video-based eye tracking system

Oculo-Cognitive Addition test (OCAT)

Intervention Type 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

Intervention Type DEVICE

Non-invasive eye-tracking device

Interventions

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Oxycodone

5 mg tablet

Intervention Type DRUG

Placebo

Oxycodone-matched placebo tablet

Intervention Type DRUG

EyeLink 1000 Plus

Non-invasive video-based eye tracking system

Intervention Type DEVICE

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.

Intervention Type DIAGNOSTIC_TEST

VT3mini - Eye Tracking Technology for OEMs

Non-invasive eye-tracking device

Intervention Type DEVICE

Other Intervention Names

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Oxycodone Immediate Release EyeLink EyeTech

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes