Neurologic Impairment by OpioidsNCT05489601
Non-intrusive Detection of Temporary Neurologic Impairment by Opioids
An observational study of Neurologic Impairment by Opioids, run by Zxerex Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurologic Impairment by Opioids
- What is being tested?
- Oxycodone
- Type of treatment
- Pill or oral medicine
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 29 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants recruited from area local to Scottsdale, Arizona
Who may be able to join
- 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).
Who cannot join
- Prior use of any opioids during the preceding 30 days.
- Positive urine drug test for any drug at any point during the study.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Oxycodone in 5mg increments up to a maximum of 10mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 1 hour post-dose for 3 hours across 3 sessions, minimum 48 hours between sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start28 Feb 2020
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic Impairment by OpioidsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zxerex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489601
- Sponsor's protocol ID
- OpioidsPhaseI
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05489601
- Acronym / sponsor ID
- OpioidsPhaseI
- Conditions
- Neurologic Impairment by Opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Zxerex CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Drug: Oxycodone* 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. |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants recruited from area local to Scottsdale, Arizona
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- Prior use of any opioids during the preceding 30 days.
- Positive urine drug test for any drug at any point during the study.
- Pregnancy
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 |
|---|---|---|
| OxycodoneOxycodone in 5mg increments up to a maximum of 10mg | Drug | Participants |
Primary outcome
Eye movement velocity
Time frame: 1 hour post-dose for 3 hours across 3 sessions, minimum 48 hours between sessions.
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).
Pupil area change
Time frame: 1 hour post-dose for 3 hours across 3 sessions, minimum 48 hours between sessions.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Impairment by Opioids, run by Zxerex Corporation 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 2 inclusion and 3 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 Aug 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Eye movement velocity (time frame: 1 hour post-dose for 3 hours across 3 sessions, minimum 48 hours between sessions.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2022.