Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
Overview
- Phase
- Phase 1
- Intervention
- Oxycodone
- Conditions
- Healthy
- Sponsor
- Mayo Clinic
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Oculo-Cognitive Addition Test (OCAT) Completion Time
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Gaurav N. Pradhan
Principal Investigator
Mayo Clinic
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.
Arms & Interventions
Oxycodone, Then Placebo
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.
Intervention: Oxycodone
Oxycodone, Then Placebo
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.
Intervention: Placebo
Oxycodone, Then Placebo
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.
Intervention: EyeLink 1000 Plus
Oxycodone, Then Placebo
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.
Intervention: Oculo-Cognitive Addition test (OCAT)
Oxycodone, Then Placebo
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.
Intervention: VT3mini - Eye Tracking Technology for OEMs
Placebo, Then Oxycodone
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.
Intervention: Oxycodone
Placebo, Then Oxycodone
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.
Intervention: Placebo
Placebo, Then Oxycodone
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.
Intervention: EyeLink 1000 Plus
Placebo, Then Oxycodone
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.
Intervention: Oculo-Cognitive Addition test (OCAT)
Placebo, Then Oxycodone
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.
Intervention: VT3mini - Eye Tracking Technology for OEMs
Outcomes
Primary Outcomes
Oculo-Cognitive Addition Test (OCAT) Completion Time
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Time it takes participants to complete the OCAT measured in seconds.
Saccadic Latency
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in seconds
Fixation Time - Low Cognitive Workload
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Fixation Time - Medium Cognitive Workload
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Fixation Time - High Cognitive Workload
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Diagonal Saccadic Velocity
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s
Horizontal Saccadic Velocity
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s
Vertical Saccadic Velocity
Time Frame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s