Non-intrusive Detection of Temporary Neurologic Impairment by Opioids

NCT05489601 | Completed FDA Drug

• 1 other identifier: OpioidsPhaseI
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to prove the feasibility of a non-invasive means to identify temporary neurological impairment resulting from the use of a commonly prescribed opioid by identifying an oculomotor biosignature associated with temporary neurologic impairment in pain-free opioid-naïve subjects, and to initiate the development of such a signature. The investigators also sought to establish the presence of a dose-dependent biosignature for opioid impairment.

Conditions

Neurologic Impairment by Opioids

Outcome Measures

Primary Outcomes (2)

• Eye movement velocity

  Eye position over time is recorded and tracked using a specialized eye-tracking camera system during a battery of visual tests under control and oxycodone challenge conditions. This data is converted to a velocity measure as millimeters per second (mm/second) and then converted to an angular velocity as degrees of visual angle per second (dva/second).

  1 hour post-dose for 3 hours across 3 sessions, minimum 48 hours between sessions.

• Pupil area change

  Changes in pupil area are recorded over time using specialized a eye-tracking camera system. Screen illumination is abruptly changed from dark to maximum brightness and back while the pupils size is measured. The pupil area is represented in the units millimeters squared (mm\^2).

  1 hour post-dose for 3 hours across 3 sessions, minimum 48 hours between sessions.

Study Arms (1)

Participants

* Adults between 21 and 59 years of age. * Males and females; women must practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD). * Subjects have taken an opioid prescription for pain management within the prior 24 months and have not used any opioids during the preceding 30 days. * Subjects are required to have a negative urine drug test. At any point during the study, If a subject is found to have a positive drug test, the subject will be discontinued from the study.

Drug: Oxycodone

Interventions

Oxycodone DRUG

Oxycodone in 5mg increments up to a maximum of 10mg

Participants

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants recruited from area local to Scottsdale, Arizona

You may qualify if:

• Adults between 21 and 59 years of age.
• Males and females; women must practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD).

You may not qualify if:

• Prior use of any opioids during the preceding 30 days.
• Positive urine drug test for any drug at any point during the study.
• Pregnancy

Sponsors & Collaborators

• Zxerex Corporation: lead

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85260, United States

Location

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 5, 2022
• Study Start: February 28, 2020
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

US (1)