Clinical trial NCT05489601: Non-intrusive Detection of Temporary Neurologic Impairment by Opioids
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Impairment by Opioids
Lead sponsor: Zxerex Corporation
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants recruited from area local to Scottsdale, Arizona

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.

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

Primary outcomes:
measure: Eye movement velocity
timeFrame: 1 hour post-dose for 3 hours across 3 sessions, minimum 48 hours between sessions.
measure: Pupil area change
timeFrame: 1 hour post-dose for 3 hours across 3 sessions, minimum 48 hours between sessions.
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
References: