Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: OxycodoneDrug: PlaceboDevice: EyeLink 1000 PlusDiagnostic Test: Oculo-Cognitive Addition test (OCAT)Device: VT3mini - Eye Tracking Technology for OEMs
- Registration Number
- NCT04223609
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oxycodone, Then Placebo Oculo-Cognitive Addition test (OCAT) 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. Oxycodone, Then Placebo VT3mini - Eye Tracking Technology for OEMs 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. Placebo, Then Oxycodone EyeLink 1000 Plus 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. Oxycodone, Then Placebo EyeLink 1000 Plus 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. Placebo, Then Oxycodone Placebo 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. Oxycodone, Then Placebo 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. Placebo, Then Oxycodone Oculo-Cognitive Addition test (OCAT) 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. Placebo, Then Oxycodone VT3mini - Eye Tracking Technology for OEMs 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. Oxycodone, Then Placebo Oxycodone 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. Placebo, Then Oxycodone 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.
- Primary Outcome Measures
Name Time Method Oculo-Cognitive Addition Test (OCAT) Completion Time 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 Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) measured in seconds
Fixation Time - Low Cognitive Workload Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) measure in milliseconds
Fixation Time - Medium Cognitive Workload Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) measure in milliseconds
Fixation Time - High Cognitive Workload Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) measure in milliseconds
Diagonal Saccadic Velocity Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) measured in deg/s
Horizontal Saccadic Velocity Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) measured in deg/s
Vertical Saccadic Velocity Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) measured in deg/s
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic in Arizona🇺🇸Scottsdale, Arizona, United States