Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04223609

Enrollment

Registered

2020-01-10

Start date

2020-02-28

Completion date

2022-04-11

Last updated

2023-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DEVICEEyeLink 1000 Plus

Non-invasive video-based eye tracking system

DRUGOxycodone

5 mg tablet

DRUGPlacebo

Oxycodone-matched placebo tablet

DIAGNOSTIC_TESTOculo-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.

DEVICEVT3mini - Eye Tracking Technology for OEMs

Non-invasive eye-tracking device

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 59 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Oxycodone: 5 mg tablet Placebo: Oxycodone-matched placebo tablet EyeLink 1000 Plus: Non-invasive video-based eye tracking system 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. VT3mini - Eye Tracking Technology for OEMs: Non-invasive eye-tracking device	6
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. Oxycodone: 5 mg tablet Placebo: Oxycodone-matched placebo tablet EyeLink 1000 Plus: Non-invasive video-based eye tracking system 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. VT3mini - Eye Tracking Technology for OEMs: Non-invasive eye-tracking device	8
Total	14

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	1
Overall Study	Missed last visit	0	1

Baseline characteristics

Characteristic	Oxycodone, Then Placebo	Total	Placebo, Then Oxycodone
Age, Continuous	29.5 years STANDARD_DEVIATION 5.3	31.2 years STANDARD_DEVIATION 7	32.6 years STANDARD_DEVIATION 8.2
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	3 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants	9 Participants	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) White	3 Participants	10 Participants	7 Participants
Region of Enrollment United States	6 participants	14 participants	8 participants
Sex: Female, Male Female	1 Participants	6 Participants	5 Participants
Sex: Female, Male Male	5 Participants	8 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 13	0 / 14
other Total, other adverse events	1 / 13	0 / 14
serious Total, serious adverse events	0 / 13	0 / 14