Trial Outcomes & Findings for Non-intrusive Detection of Temporary Neurologic Impairment By Opioids (NCT NCT04223609)
NCT ID: NCT04223609
Last Updated: 2023-04-05
Results Overview
Time it takes participants to complete the OCAT measured in seconds.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Results posted on
2023-04-05
Participant Flow
Participant milestones
| Measure |
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.
Oxycodone: 5 mg tablet
Placebo: Oxycodone-matched placebo tablet
EyeLink 1000 Plus: Non-invasive video-based eye tracking system
Oculo-Cognitive Addition test (OCAT): 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.
VT3mini - Eye Tracking Technology for OEMs: Non-invasive eye-tracking device
|
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.
Oxycodone: 5 mg tablet
Placebo: Oxycodone-matched placebo tablet
EyeLink 1000 Plus: Non-invasive video-based eye tracking system
Oculo-Cognitive Addition test (OCAT): 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.
VT3mini - Eye Tracking Technology for OEMs: Non-invasive eye-tracking device
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
Oxycodone: 5 mg tablet
Placebo: Oxycodone-matched placebo tablet
EyeLink 1000 Plus: Non-invasive video-based eye tracking system
Oculo-Cognitive Addition test (OCAT): 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.
VT3mini - Eye Tracking Technology for OEMs: Non-invasive eye-tracking device
|
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.
Oxycodone: 5 mg tablet
Placebo: Oxycodone-matched placebo tablet
EyeLink 1000 Plus: Non-invasive video-based eye tracking system
Oculo-Cognitive Addition test (OCAT): 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.
VT3mini - Eye Tracking Technology for OEMs: Non-invasive eye-tracking device
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Missed last visit
|
0
|
1
|
Baseline Characteristics
Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
Baseline characteristics by cohort
| Measure |
Oxycodone, Then Placebo
n=6 Participants
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: 5 mg tablet
Placebo: Oxycodone-matched placebo tablet
EyeLink 1000 Plus: Non-invasive video-based eye tracking system
Oculo-Cognitive Addition test (OCAT): 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.
VT3mini - Eye Tracking Technology for OEMs: Non-invasive eye-tracking device
|
Placebo, Then Oxycodone
n=8 Participants
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: 5 mg tablet
Placebo: Oxycodone-matched placebo tablet
EyeLink 1000 Plus: Non-invasive video-based eye tracking system
Oculo-Cognitive Addition test (OCAT): 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.
VT3mini - Eye Tracking Technology for OEMs: Non-invasive eye-tracking device
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 5.3 • n=93 Participants
|
32.6 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
31.2 years
STANDARD_DEVIATION 7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
14 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Oxycodone
n=13 Participants
Participants who received 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.
|
Placebo
n=13 Participants
Participants who received 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.
|
|---|---|---|
|
Oculo-Cognitive Addition Test (OCAT) Completion Time
Baseline
|
57.22 seconds
Standard Deviation 10.23
|
57.22 seconds
Standard Deviation 10.23
|
|
Oculo-Cognitive Addition Test (OCAT) Completion Time
Approx. 30 minutes after initial 5 mg dose
|
59.56 seconds
Standard Deviation 12.01
|
58.18 seconds
Standard Deviation 10.15
|
|
Oculo-Cognitive Addition Test (OCAT) Completion Time
Approx. 30 minutes after second 5 mg dose
|
56.12 seconds
Standard Deviation 11.81
|
54.47 seconds
Standard Deviation 12.66
|
PRIMARY outcome
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)measured in seconds
Outcome measures
| Measure |
Oxycodone
n=13 Participants
Participants who received 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.
|
Placebo
n=13 Participants
Participants who received 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.
|
|---|---|---|
|
Saccadic Latency
Baseline
|
0.40 seconds
Standard Deviation 0.07
|
0.40 seconds
Standard Deviation 0.07
|
|
Saccadic Latency
Approx. 30 minutes after initial 5 mg dose
|
0.45 seconds
Standard Deviation 0.13
|
0.38 seconds
Standard Deviation 0.08
|
|
Saccadic Latency
Approx. 30 minutes after second 5 mg dose
|
0.38 seconds
Standard Deviation 0.08
|
0.38 seconds
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)measure in milliseconds
Outcome measures
| Measure |
Oxycodone
n=13 Participants
Participants who received 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.
|
Placebo
n=13 Participants
Participants who received 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.
|
|---|---|---|
|
Fixation Time - Low Cognitive Workload
Baseline
|
1079.82 milliseconds
Standard Deviation 187.66
|
1079.82 milliseconds
Standard Deviation 187.66
|
|
Fixation Time - Low Cognitive Workload
Approx. 30 minutes after initial 5 mg dose
|
1145.60 milliseconds
Standard Deviation 239.89
|
1198.86 milliseconds
Standard Deviation 204.36
|
|
Fixation Time - Low Cognitive Workload
Approx. 30 minutes after second 5 mg dose
|
1132.70 milliseconds
Standard Deviation 285.69
|
1073.96 milliseconds
Standard Deviation 260.28
|
PRIMARY outcome
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)measure in milliseconds
Outcome measures
| Measure |
Oxycodone
n=13 Participants
Participants who received 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.
|
Placebo
n=13 Participants
Participants who received 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.
|
|---|---|---|
|
Fixation Time - Medium Cognitive Workload
Baseline
|
1316.45 milliseconds
Standard Deviation 239.58
|
1316.45 milliseconds
Standard Deviation 239.58
|
|
Fixation Time - Medium Cognitive Workload
Approx. 30 minutes after initial 5 mg dose
|
1347.90 milliseconds
Standard Deviation 236.69
|
1381.20 milliseconds
Standard Deviation 286.50
|
|
Fixation Time - Medium Cognitive Workload
Approx. 30 minutes after second 5 mg dose
|
1249.38 milliseconds
Standard Deviation 329.62
|
1264.03 milliseconds
Standard Deviation 346.36
|
PRIMARY outcome
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)measure in milliseconds
Outcome measures
| Measure |
Oxycodone
n=13 Participants
Participants who received 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.
|
Placebo
n=13 Participants
Participants who received 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.
|
|---|---|---|
|
Fixation Time - High Cognitive Workload
Approx. 30 minutes after second 5 mg dose
|
1564.34 milliseconds
Standard Deviation 324.77
|
1528.17 milliseconds
Standard Deviation 419.64
|
|
Fixation Time - High Cognitive Workload
Baseline
|
1572.63 milliseconds
Standard Deviation 303.23
|
1572.63 milliseconds
Standard Deviation 303.23
|
|
Fixation Time - High Cognitive Workload
Approx. 30 minutes after initial 5 mg dose
|
1644.75 milliseconds
Standard Deviation 344.26
|
1641.86 milliseconds
Standard Deviation 345.10
|
PRIMARY outcome
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)measured in deg/s
Outcome measures
| Measure |
Oxycodone
n=13 Participants
Participants who received 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.
|
Placebo
n=13 Participants
Participants who received 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.
|
|---|---|---|
|
Diagonal Saccadic Velocity
Baseline
|
284.81 deg/s
Standard Deviation 31.32
|
284.81 deg/s
Standard Deviation 31.32
|
|
Diagonal Saccadic Velocity
Approx. 30 minutes after initial 5 mg dose
|
293.82 deg/s
Standard Deviation 36.48
|
277.44 deg/s
Standard Deviation 44.99
|
|
Diagonal Saccadic Velocity
Approx. 30 minutes after second 5 mg dose
|
281.42 deg/s
Standard Deviation 31.95
|
285.74 deg/s
Standard Deviation 25.84
|
PRIMARY outcome
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)measured in deg/s
Outcome measures
| Measure |
Oxycodone
n=13 Participants
Participants who received 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.
|
Placebo
n=13 Participants
Participants who received 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.
|
|---|---|---|
|
Horizontal Saccadic Velocity
Baseline
|
302.93 deg/s
Standard Deviation 28.54
|
302.93 deg/s
Standard Deviation 28.54
|
|
Horizontal Saccadic Velocity
Approx. 30 minutes after initial 5 mg dose
|
288.52 deg/s
Standard Deviation 25.29
|
283.77 deg/s
Standard Deviation 27.21
|
|
Horizontal Saccadic Velocity
Approx. 30 minutes after second 5 mg dose
|
289.74 deg/s
Standard Deviation 32.77
|
286.66 deg/s
Standard Deviation 23.57
|
PRIMARY outcome
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)measured in deg/s
Outcome measures
| Measure |
Oxycodone
n=13 Participants
Participants who received 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.
|
Placebo
n=13 Participants
Participants who received 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.
|
|---|---|---|
|
Vertical Saccadic Velocity
Baseline
|
298.52 deg/s
Standard Deviation 38.30
|
298.52 deg/s
Standard Deviation 38.30
|
|
Vertical Saccadic Velocity
Approx. 30 minutes after initial 5 mg dose
|
274.51 deg/s
Standard Deviation 28.73
|
272.93 deg/s
Standard Deviation 48.12
|
|
Vertical Saccadic Velocity
Approx. 30 minutes after second 5 mg dose
|
309.83 deg/s
Standard Deviation 126.58
|
276.21 deg/s
Standard Deviation 27.38
|
Adverse Events
Oxycodone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxycodone
n=13 participants at risk
Participants who received 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.
|
Placebo
n=14 participants at risk
Participants who received 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.
|
|---|---|---|
|
Nervous system disorders
Nausea and dizziness
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately one week on all participants.
|
0.00%
0/14 • Adverse events were collected from baseline to end of study participation for a total of approximately one week on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place