Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

NCT04223609 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: 19-004883
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

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.

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.

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

Interventions

Oxycodone DRUG

5 mg tablet

Also known as: Oxycodone Immediate Release

Oxycodone, Then Placebo; Placebo, Then Oxycodone

Placebo DRUG

Oxycodone-matched placebo tablet

Oxycodone, Then Placebo; Placebo, Then Oxycodone

EyeLink 1000 Plus DEVICE

Non-invasive video-based eye tracking system

Also known as: EyeLink

Oxycodone, Then Placebo; Placebo, Then Oxycodone

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.

Oxycodone, Then Placebo; Placebo, Then Oxycodone

VT3mini - Eye Tracking Technology for OEMs DEVICE

Non-invasive eye-tracking device

Also known as: EyeTech

Oxycodone, Then Placebo; Placebo, Then Oxycodone

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Gaurav N. Pradhan, PhD
• Organization: Mayo Clinic

Pradhan.Gaurav@mayo.edu

480-301-5351

Study Officials

• Gaurav Pradhan, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 10, 2020
• Study Start: February 28, 2020
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: April 5, 2023
• Results First Posted: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)