Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 14
Healthy volunteers: yes

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:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Oxycodone intervention 2: Placebo intervention 3: EyeLink 1000 Plus intervention 4: Oculo-Cognitive Addition test (OCAT) intervention 5: VT3mini - Eye Tracking Technology for OEMs
Intervention descriptions: intervention 1: 5 mg tablet intervention 2: Oxycodone-matched placebo tablet intervention 3: Non-invasive video-based eye tracking system intervention 4: Subject will have to look for numbers on a screen and add these numbers together. OCAT will be presented on a computer screen with attached eye tracking device at the bottom part. intervention 5: Non-invasive eye-tracking device

Protocol document:
Prot_SAP_000.pdf: 
 
 
Non-intrusive Detection of Temporary 
Neurologic Impairment By Opioids 
 
NCT04223609 
 
November 1, 2021