MedPath

Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Oxycodone
Drug: Placebo
Device: EyeLink 1000 Plus
Diagnostic 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
GroupInterventionDescription
Oxycodone, Then PlaceboOculo-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 PlaceboVT3mini - Eye Tracking Technology for OEMsParticipants 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 OxycodoneEyeLink 1000 PlusParticipants 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 PlaceboEyeLink 1000 PlusParticipants 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 OxycodonePlaceboParticipants 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 PlaceboPlaceboParticipants 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 OxycodoneOculo-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 OxycodoneVT3mini - Eye Tracking Technology for OEMsParticipants 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 PlaceboOxycodoneParticipants 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 OxycodoneOxycodoneParticipants 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
NameTimeMethod
Oculo-Cognitive Addition Test (OCAT) Completion TimeBaseline, 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 LatencyBaseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

measured in seconds

Fixation Time - Low Cognitive WorkloadBaseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

measure in milliseconds

Fixation Time - Medium Cognitive WorkloadBaseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

measure in milliseconds

Fixation Time - High Cognitive WorkloadBaseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

measure in milliseconds

Diagonal Saccadic VelocityBaseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

measured in deg/s

Horizontal Saccadic VelocityBaseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

measured in deg/s

Vertical Saccadic VelocityBaseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

measured in deg/s

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic in Arizona

🇺🇸

Scottsdale, Arizona, United States

Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
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