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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone, Then Placebo | Experimental | 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. |
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| Placebo, Then Oxycodone | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | 5 mg tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Oculo-Cognitive Addition Test (OCAT) Completion Time | Time it takes participants to complete the OCAT measured in seconds. | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
| Saccadic Latency | measured in seconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
| Fixation Time - Low Cognitive Workload | measure in milliseconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
| Fixation Time - Medium Cognitive Workload | measure in milliseconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
| Fixation Time - High Cognitive Workload | measure in milliseconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
| Diagonal Saccadic Velocity | measured in deg/s | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
| Horizontal Saccadic Velocity | measured in deg/s | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaurav Pradhan, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oculo-Cognitive Addition Test (OCAT) Completion Time | Time it takes participants to complete the OCAT measured in seconds. | Posted | Mean | Standard Deviation | seconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
|
Adverse events were collected from baseline to end of study participation for a total of approximately one week on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxycodone | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gaurav N. Pradhan, PhD | Mayo Clinic | 480-301-5351 | Pradhan.Gaurav@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2021 | Feb 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Placebo | Drug | Oxycodone-matched placebo tablet |
|
| EyeLink 1000 Plus | Device | Non-invasive video-based eye tracking system |
|
|
| Oculo-Cognitive Addition test (OCAT) | Diagnostic Test | 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 | Device | Non-invasive eye-tracking device |
|
|
| Vertical Saccadic Velocity | measured in deg/s | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Placebo |
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. |
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| Primary | Saccadic Latency | measured in seconds | Posted | Mean | Standard Deviation | seconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
|
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| Primary | Fixation Time - Low Cognitive Workload | measure in milliseconds | Posted | Mean | Standard Deviation | milliseconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
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| Primary | Fixation Time - Medium Cognitive Workload | measure in milliseconds | Posted | Mean | Standard Deviation | milliseconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
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| Primary | Fixation Time - High Cognitive Workload | measure in milliseconds | Posted | Mean | Standard Deviation | milliseconds | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
|
|
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| Primary | Diagonal Saccadic Velocity | measured in deg/s | Posted | Mean | Standard Deviation | deg/s | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
|
|
|
| Primary | Horizontal Saccadic Velocity | measured in deg/s | Posted | Mean | Standard Deviation | deg/s | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
|
|
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| Primary | Vertical Saccadic Velocity | measured in deg/s | Posted | Mean | Standard Deviation | deg/s | Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes) |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Placebo | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Approx. 30 minutes after second 5 mg dose |
|
| Approx. 30 minutes after second 5 mg dose |
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| Approx. 30 minutes after second 5 mg dose |
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| Approx. 30 minutes after second 5 mg dose |
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| Approx. 30 minutes after second 5 mg dose |
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| Approx. 30 minutes after second 5 mg dose |
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| Approx. 30 minutes after second 5 mg dose |
|