Non-intrusive Detection of Temporary Neurologic Impairment by Opioids

NCT ID: NCT05489601

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2022-03-29

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.

Detailed Description

To determine the detrimental effects of opioid intoxication on normal oculomotor function, the investigators will collect data from up to 25 subjects before and during oxycodone induced intoxication. A within-subjects design will be used, and subjects will be tested under conditions of no dose (placebo), low dose, and high dose. Subjects will be tested during 3 sessions (baseline, placebo, oxycodone); separated by 7 days to allow for complete washout of any drug that was administered. Subjects will perform tests of visual fixation, saccade speed and saccade accuracy, cognitive control over saccades, cognitive control over visual scanning, and visual pursuit. Eye movement data will be collected using an SR Research EyeLink 1000 Plus eye tracking system.

Analysis of the data will be performed by comparing each subject state against the baseline measurements, where baseline represents an unimpaired subject state. Based on prior work with marijuana intoxication, the investigators expect that this data and analysis will successfully reveal a constellation of oculomotor dynamics that can be used to classify whether an individual is or is not currently impaired by oxycodone. Based on published studies, the investigators anticipate these changes will generalize across the opioid class, creating a biosignature of opioid impairment.

Conditions

Neurologic Impairment by Opioids

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Oxycodone

Intervention Type: DRUG

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

Interventions

Oxycodone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zxerex Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OpioidsPhaseI

Identifier Type: -

Identifier Source: org_study_id