Phase 2
N=14
Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04223609 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Oculo-Cognitive Addition Test (OCAT) Completion Time — 57.22; 57.22; 59.56; 58.18 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxycodone (Drug); Placebo (Drug); EyeLink 1000 Plus (Device); Oculo-Cognitive Addition test (OCAT) (Diagnostic_test); VT3mini - Eye Tracking Technology for OEMs (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oculo-Cognitive Addition Test (OCAT) Completion Time |
57.22; 57.22; 59.56; 58.18; 56.12; 54.47 | — |
| PRIMARY Saccadic Latency |
0.40; 0.40; 0.45; 0.38; 0.38; 0.38 | — |
| PRIMARY Fixation Time - Low Cognitive Workload |
1079.82; 1079.82; 1145.60; 1198.86; 1132.70; 1073.96 | — |
| PRIMARY Fixation Time - Medium Cognitive Workload |
1316.45; 1316.45; 1347.90; 1381.20; 1249.38; 1264.03 | — |
| PRIMARY Fixation Time - High Cognitive Workload |
1572.63; 1572.63; 1644.75; 1641.86; 1564.34; 1528.17 | — |
| PRIMARY Diagonal Saccadic Velocity |
284.81; 284.81; 293.82; 277.44; 281.42; 285.74 | — |
| PRIMARY Horizontal Saccadic Velocity |
302.93; 302.93; 288.52; 283.77; 289.74; 286.66 | — |
| PRIMARY Vertical Saccadic Velocity |
298.52; 298.52; 274.51; 272.93; 309.83; 276.21 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04223609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.