Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

Mayo Clinic

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Diagnostic Test: Oculo-Cognitive Addition test (OCAT); Device: EyeLink 1000 Plus; Device: VT3mini - Eye Tracking Technology for OEMs; Drug: Oxycodone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04223609

19-004883

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 21 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Oxycodone, Then Placebo

Experimental group

Description:

Participants first receive initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with placebo.

Treatment:

Drug: Placebo

Diagnostic Test: Oculo-Cognitive Addition test (OCAT)

Drug: Oxycodone

Device: VT3mini - Eye Tracking Technology for OEMs

Device: EyeLink 1000 Plus

Placebo, Then Oxycodone

Experimental group

Description:

Participants first receive initial dose of placebo 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a set of standardized oculomotor testing for 40 minutes. After the initial testing, a second dose of placebo 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with oxycodone.

Treatment:

Drug: Placebo

Diagnostic Test: Oculo-Cognitive Addition test (OCAT)

Drug: Oxycodone

Device: VT3mini - Eye Tracking Technology for OEMs

Device: EyeLink 1000 Plus