HealthyPhase 1/2NCT04223609

Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

A Phase 1/2 study testing Oxycodone, EyeLink 1000 Plus and Oculo-Cognitive Addition test (OCAT) in people with Healthy, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Oxycodone, EyeLink 1000 Plus and Oculo-Cognitive Addition test (OCAT)
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 28 Feb 2020to 11 Apr 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259

Other trials in United States

About this study

Conditions: Healthy
Being tested: Oxycodone, Placebo, EyeLink 1000 Plus, Oculo-Cognitive Addition test (OCAT), VT3mini - Eye Tracking Technology for OEMs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxycodoneDrug
Also called Oxycodone Immediate Release
5 mg tablet
PlaceboDrug
Oxycodone-matched placebo tablet
EyeLink 1000 PlusDevice
Also called EyeLink
Non-invasive video-based eye tracking system
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 OEMsDevice
Also called EyeTech
Non-invasive eye-tracking device

Study groups in NCT04223609
Study group	Role	What they receive
Oxycodone, Then Placebo	Experimental	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. Receives: Drug: Oxycodone; Drug: Placebo; Device: EyeLink 1000 Plus; Diagnostic Test: Oculo-Cognitive Addition test (OCAT); Device: VT3mini - Eye Tracking Technology for OEMs
Placebo, Then Oxycodone	Experimental	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. Receives: Drug: Oxycodone; Drug: Placebo; Device: EyeLink 1000 Plus; Diagnostic Test: Oculo-Cognitive Addition test (OCAT); Device: VT3mini - Eye Tracking Technology for OEMs

What is being measured

The primary outcome is the main question the study is designed to answer.

Oculo-Cognitive Addition Test (OCAT) Completion Time
Time it takes participants to complete the OCAT measured in seconds.
Measured: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Saccadic Latency
measured in seconds
Measured: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Fixation Time - Low Cognitive Workload
measure in milliseconds
Measured: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Fixation Time - Medium Cognitive Workload
measure in milliseconds
Measured: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Fixation Time - High Cognitive Workload
measure in milliseconds
Measured: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Diagonal Saccadic Velocity
measured in deg/s
Measured: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Horizontal Saccadic Velocity
measured in deg/s
Measured: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Vertical Saccadic Velocity
measured in deg/s
Measured: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 202011 Apr 2022

First posted10 Jan 2020
Study start28 Feb 2020
Primary completion11 Apr 2022
Study completion11 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04223609
Sponsor's protocol ID: 19-004883
Status last verified: Mar 2023
First submitted: 8 Jan 2020
Last updated: 5 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
ClinicalTrials.gov ID: NCT04223609
Acronym / sponsor ID: 19-004883
Conditions: Healthy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 28 Feb 2020 (actual)
Primary completion: 11 Apr 2022 (actual)
Study completion: 11 Apr 2022 (actual)
First posted: 10 Jan 2020 (actual)
Results: Posted 5 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Oxycodone, Then Placebo	Experimental	Drug: Oxycodone, Drug: Placebo, Device: EyeLink 1000 Plus, Diagnostic Test: Oculo-Cognitive Addition test (OCAT), Device: VT3mini - Eye Tracking Technology for OEMsParticipants 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.
Placebo, Then Oxycodone	Experimental	Drug: Oxycodone, Drug: Placebo, Device: EyeLink 1000 Plus, Diagnostic Test: Oculo-Cognitive Addition test (OCAT), Device: VT3mini - Eye Tracking Technology for OEMsParticipants 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.

Who may qualify

Ages: 21 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxycodoneAlso: Oxycodone Immediate Release5 mg tablet	Drug	Oxycodone, Then Placebo, Placebo, Then Oxycodone
PlaceboOxycodone-matched placebo tablet	Drug	Oxycodone, Then Placebo, Placebo, Then Oxycodone
EyeLink 1000 PlusAlso: EyeLinkNon-invasive video-based eye tracking system	Device	Oxycodone, Then Placebo, Placebo, Then Oxycodone
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.	Diagnostic test	Oxycodone, Then Placebo, Placebo, Then Oxycodone
VT3mini - Eye Tracking Technology for OEMsAlso: EyeTechNon-invasive eye-tracking device	Device	Oxycodone, Then Placebo, Placebo, Then Oxycodone

Primary outcome

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

Results and safety

Results posted to the registry on 5 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxycodone, Then Placebo	6	6
Placebo, Then Oxycodone	8	6

Primary outcome: Oculo-Cognitive Addition Test (OCAT) Completion Time

Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes). Mean (Standard Deviation). Unit: seconds

Measure	Oxycodone n = 13	Placebo n = 13
Baseline	57.22 (10.23)	57.22 (10.23)
Approx. 30 minutes after initial 5 mg dose	59.56 (12.01)	58.18 (10.15)
Approx. 30 minutes after second 5 mg dose	56.12 (11.81)	54.47 (12.66)

Primary outcome: Saccadic Latency

Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes). Mean (Standard Deviation). Unit: seconds

Measure	Oxycodone n = 13	Placebo n = 13
Baseline	0.40 (0.07)	0.40 (0.07)
Approx. 30 minutes after initial 5 mg dose	0.45 (0.13)	0.38 (0.08)
Approx. 30 minutes after second 5 mg dose	0.38 (0.08)	0.38 (0.10)

Primary outcome: Fixation Time - Low Cognitive Workload

Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes). Mean (Standard Deviation). Unit: milliseconds

Measure	Oxycodone n = 13	Placebo n = 13
Baseline	1079.82 (187.66)	1079.82 (187.66)
Approx. 30 minutes after initial 5 mg dose	1145.60 (239.89)	1198.86 (204.36)
Approx. 30 minutes after second 5 mg dose	1132.70 (285.69)	1073.96 (260.28)

Primary outcome: Fixation Time - Medium Cognitive Workload

Time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes). Mean (Standard Deviation). Unit: milliseconds

Measure	Oxycodone n = 13	Placebo n = 13
Baseline	1316.45 (239.58)	1316.45 (239.58)
Approx. 30 minutes after initial 5 mg dose	1347.90 (236.69)	1381.20 (286.50)
Approx. 30 minutes after second 5 mg dose	1249.38 (329.62)	1264.03 (346.36)

Adverse events

Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately one week on all participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxycodone	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Placebo	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gaurav Pradhan, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oxycodone, EyeLink 1000 Plus and Oculo-Cognitive Addition test (OCAT) in people with Healthy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oculo-Cognitive Addition Test (OCAT) Completion Time (time frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04223609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.