Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

Study Overview
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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.

Official Title
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Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Placebo
* Device: EyeLink 1000 Plus
* Diagnostic Test: Oculo-Cognitive Addition test (OCAT)
* Device: VT3mini - Eye Tracking Technology for OEMs


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone, Then Placebo<br>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<br>* 5 mg tablet<br>* Other names: Oxycodone Immediate Release;Drug: Placebo<br>* Oxycodone-matched placebo tablet<br>Device: EyeLink 1000 Plus<br>* Non-invasive video-based eye tracking system<br>* Other names: EyeLink;Diagnostic Test: Oculo-Cognitive Addition test (OCAT)<br>* 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.<br>Device: VT3mini - Eye Tracking Technology for OEMs<br>* Non-invasive eye-tracking device<br>* Other names: EyeTech;|
| Experimental: Placebo, Then Oxycodone<br>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<br>* 5 mg tablet<br>* Other names: Oxycodone Immediate Release;Drug: Placebo<br>* Oxycodone-matched placebo tablet<br>Device: EyeLink 1000 Plus<br>* Non-invasive video-based eye tracking system<br>* Other names: EyeLink;Diagnostic Test: Oculo-Cognitive Addition test (OCAT)<br>* 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.<br>Device: VT3mini - Eye Tracking Technology for OEMs<br>* Non-invasive eye-tracking device<br>* Other names: EyeTech;|

What is the study measuring?
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Primary Outcome Measures

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