Cannabidiol EffectsPhase 1NCT06686914
The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex
A Phase 1 study testing Cannabidiol (CBD) Oil 300mg and Cannabidiol (CBD) Oil 150mg in people with Cannabidiol Effects and Driving Performance, run by West Virginia University at 1 site in United States.
Trial summary
The objectives/purpose of this study are to comprehensively investigate the effects of non-prescription CBD on driving performance, drowsiness, sedation, and cognitive function in a large sample of healthy adults aged 18-30 years, with additional characterization of effects by dose and by sex, using a rigorous RCT… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabidiol Effects, Driving Performance
- What is being tested?
- Cannabidiol (CBD) Oil 300mg and Cannabidiol (CBD) Oil 150mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 1 May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Possess a current drivers' license
- Driven a motor vehicle at least once in the past 30 days
- Able to read English
- Test negative for all substances on a urine drug test and complete a test drive to ensure the absence of simulation sickness
- Not taking any daily prescription medications (excluding birth control)
- Not diagnosed with any serious chronic disease by a licensed healthcare provider (including but not limited to Alzheimer's and related dementias, Parkinson's disease or other neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental illness, arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and fibromyalgia)
- Have an individual willing to drive them home after testing or be taken home by study staff after testing
Who cannot join
- Currently smoke, vape or use tobacco products, used CBD in the past 30 days
- Used illegal drugs in the past 30 days (e.g., cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid diethylamide, psilocybin mushrooms, or marijuana)
- Are pregnant or lactating at time of study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Toni M Rudisill, PhD, 304-293-0687, trudisill@hsc.wvu.edu
Toni M Rudisill, PhD
About this study
The objectives/purpose of this study are to comprehensively investigate the effects of non-prescription CBD on driving performance, drowsiness, sedation, and cognitive function in a large sample of healthy adults aged 18-30 years, with additional characterization of effects by dose and by sex, using a rigorous RCT design which will naturally mitigate confounding factors.
- Conditions
- Cannabidiol Effects, Driving Performance
- Being tested
- Cannabidiol (CBD) Oil 300mg, Cannabidiol (CBD) Oil 150mg, Placebo Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD) Oil 300mgDrug
Cannabidiol (CBD) Oil 300mg, 1 dose
Cannabidiol (CBD) Oil 150mgDrug
Cannabidiol (CBD) Oil 150mg, 1 dose
Placebo OilDrug
Placebo Oil, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) Oil 300mg | Active comparator | Cannabidiol (CBD) Oil, 300mg, 1 dose, 120 minutes prior to testing. After consumption of the respective treatment drug, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours). Receives: Drug: Cannabidiol (CBD) Oil 300mg |
| Cannabidiol (CBD) Oil 150mg | Active comparator | Cannabidiol (CBD) Oil, 150mg, 1 dose, 120 minutes prior to testing. After consumption of the respective treatment drug, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours). Receives: Drug: Cannabidiol (CBD) Oil 150mg |
| Placebo Oil | Placebo comparator | Placebo Oil 1 dose 120 minutes prior to testing. After consumption of the respective treatment drug/placebo, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours). Receives: Drug: Placebo Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean standard deviation of lateral position
The driving simulator will measure mean standard deviation which is the amount a driver is weaving within the lane during the drive. Ranges from 0 to infinity, with higher means indicating worse performance.
Measured: 150 minutes post intervention
Number of collisions
The driving simulator will measure how many times a participant crashes into other vehicles, signs, pedestrians, etc. during the simulation. Ranges from 0 to infinity, with higher numbers indicating worse performance.
Measured: 150 minutes post intervention
Mean reaction time to stimuli
The driving simulator will measure the mean reaction time (seconds) that it takes for a person to brake when exposed to stimuli. Ranges from 0 to infinity, with higher means indicating worse performance.
Measured: 150 minutes post intervention
Percent of time driver is out of travel lane
The driving simulator will measure the percent of time that each driver spends driving outside their travel lane. Percent ranges from 0-100, with higher scores indicating worse performance.
Measured: 150 minutes post intervention
Secondary outcomes (44)
Self-reported sleepiness scale
Sleepiness will be assessed via the Stanford Sleepiness Scale which is a one question Likert scale question that ask a person's sleepiness level at that moment in time. The scale ranges from 1-7 with higher scores indicating more sleepiness. This test will be administered on a laptop.
Measured: baseline
Self-reported sleepiness scale
Sleepiness will be assessed via the Stanford Sleepiness Scale which is a one question Likert scale question that ask a person's sleepiness level at that moment in time. The scale ranges from 1-7 with higher scores indicating more sleepiness. This test will be administered on a laptop.
Measured: 200 minutes post intervention
Mental sedation score
The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 1,4,11, and 13 are summed together to get a mental sedation score. Higher scores indicate more sedation. This ranges from 0-400.This test will be administered on a laptop.
Measured: baseline
Mental sedation score
The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 1,4,11, and 13 are summed together to get a mental sedation score. Higher scores indicate more sedation. This ranges from 0-400.This test will be administered on a laptop.
Measured: 200 minutes post intervention
Physical sedation score
The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 3,5,6, and 16 are summed together to get a physical sedation score. Higher scores indicate more physical sedation. This ranges from 0-400. This test will be administered on a laptop.
Measured: baseline
Physical sedation score
The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 3,5,6, and 16 are summed together to get a physical sedation score. Higher scores indicate more physical sedation. This ranges from 0-400. This test will be administered on a laptop.
Measured: 200 minutes post intervention
Mean reaction time to stimuli for PVT
The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants mean reaction time to the stimuli presented (in milliseconds). Higher times indicate worse performance. This ranges from 0 to infinity.
Measured: baseline
Mean reaction time to stimuli for PVT
The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants mean reaction time to the stimuli presented (in milliseconds). Higher times indicate worse performance. This ranges from 0 to infinity.
Measured: 200 minutes post intervention
Number of lapses in attention for PVT
The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants number of lapses in attention to presented stimuli. The test considers any reaction over 500 milliseconds to be a lapse in attention. More lapses indicate worse performance. This ranges from 0 to infinity.
Measured: Baseline
Number of lapses in attention for PVT
The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants number of lapses in attention to presented stimuli. The test considers any reaction over 500 milliseconds to be a lapse in attention. More lapses indicate worse performance. This ranges from 0 to infinity.
Measured: 200 minutes post intervention
Mean lapse duration for PVT
The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants number of lapses in attention to presented stimuli. The test considers any reaction over 500 milliseconds to be a lapse in attention. It measures the mean lapse duration for each participant. Longer lapses indicate worse performance. This ranges from 0 to infinity.
Measured: Baseline
Mean lapse duration for PVT
The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants number of lapses in attention to presented stimuli. The test considers any reaction over 500 milliseconds to be a lapse in attention. It measures the mean lapse duration for each participant. Longer lapses indicate worse performance. This ranges from 0 to infinity.
Measured: 200 minutes post intervention
Number of errors for PVT
The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure how many errors a person makes during the 10-minute test. More errors indicate worse performance. This ranges from 0 to infinity.
Measured: Baseline
Number of errors for PVT
The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure how many errors a person makes during the 10-minute test. More errors indicate worse performance. This ranges from 0 to infinity.
Measured: 200 minutes post intervention
Interference score for mean reaction on FT
The Flanker Task is administered on a laptop. The test assesses the mean reaction time to congruent and incongruent scenarios presented to participants. The score is the difference when subtracting the mean reaction time for congruent scenarios from the mean reaction time for incongruent scenarios. Larger differences indicate more impairment.
Measured: Baseline
Interference score for mean reaction on FT
The Flanker Task is administered on a laptop. The test assesses the mean reaction time to congruent and incongruent scenarios presented to participants. The score is the difference when subtracting the mean reaction time for congruent scenarios from the mean reaction time for incongruent scenarios. Larger differences indicate more impairment.
Measured: 200 minutes post intervention
Interference score for accuracy on FT
The Flanker Task is administered on a laptop. The test assesses the mean accuracy to congruent and incongruent scenarios presented to participants. The score is the difference when subtracting the mean accuracy for congruent scenarios from the mean accuracy for incongruent scenarios. Larger differences indicate more impairment.
Measured: Baseline
Interference score for accuracy on FT
The Flanker Task is administered on a laptop. The test assesses the mean accuracy to congruent and incongruent scenarios presented to participants. The score is the difference when subtracting the mean accuracy for congruent scenarios from the mean accuracy for incongruent scenarios. Larger differences indicate more impairment.
Measured: 200 minutes post intervention
Time to accurately complete the Trail Making Test Part A
Trail Making Test A provides an assessment of complex attention. This test is typically ended after 5 minutes. Thus, possible outcomes are 1-300 seconds. Greater time indicates more impairment.
Measured: Baseline
Time to accurately complete the Trail Making Test Part A
Trail Making Test A provides an assessment of complex attention. This test is typically ended after 5 minutes. Thus, possible outcomes are 1-300 seconds. Greater time indicates more impairment.
Measured: 200 minutes post intervention
Time to accurately complete the Trail Making Test Part B
TMT Part B is a neuropsychological test that assesses a person's ability to switch cognitive sets and process information. This test is typically ended after This test is typically ended after 5 minutes. thus, possible outcomes are 1-300 seconds. Greater time indicates more impairment.
Measured: Baseline
Time to accurately complete the Trail Making Test Part B
TMT Part B is a neuropsychological test that assesses a person's ability to switch cognitive sets and process information. This test is typically ended after This test is typically ended after 5 minutes. thus, possible outcomes are 1-300 seconds. Greater time indicates more impairment.
Measured: 200 minutes post intervention
Total recalled words on the Hopkins Verbal Learning test
The Hopkins Verbal Learning test assesses an individual's ability to learn a list of 12 words over 3 different learning trials. Ranges from 0 to infinity. Greater numbers of recalled words mean better performance.
Measured: Baseline
Total recalled words on the Hopkins Verbal Learning test
The Hopkins Verbal Learning test assesses an individual's ability to learn a list of 12 words over 3 different learning trials. Ranges from 0 to infinity. Greater numbers of recalled words mean better performance.
Measured: 200 minutes post intervention
Discrimination index for the Hopkins Verbal Learning test
The Hopkins Verbal Learning test assesses an individual's ability to learn a list of 12 words over 3 different learning trials. Ranges from 0 to infinity. The discrimination index is calculated by taking the number of hits minus the number of false positives. Higher values indicate better performance.
Measured: Baseline
Discrimination index for the Hopkins Verbal Learning test
The Hopkins Verbal Learning test assesses an individual's ability to learn a list of 12 words over 3 different learning trials. Ranges from 0 to infinity. The discrimination index is calculated by taking the number of hits minus the number of false positives. Higher values indicate better performance.
Measured: 200 minutes post intervention
Percentage correctness of response on Stroop Test
The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-100%. The higher the percentage, the more accurate.
Measured: Baseline
Percentage correctness of response on Stroop Test
The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-100%. The higher the percentage, the more accurate.
Measured: 200 minutes post intervention
Number congruent responses on Stroop Test
The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-infinity. Higher numbers indicate better performance.
Measured: Baseline
Number congruent responses on Stroop Test
The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-infinity. Higher numbers indicate better performance.
Measured: 200 minutes post intervention
Number incongruent responses on Stroop Test
The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-infinity. Higher numbers indicate worse performance
Measured: Baseline
Number incongruent responses on Stroop Test
The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-infinity. Higher numbers indicate worse performance
Measured: 200 minutes post intervention
Sum of scores for forward and backward responses on Digit Span test
The digit span test is a very short test that evaluates a person's cognitive status. It is frequently used in hospitals and physicians' offices in order for a clinician to quickly evaluate whether a person's cognitive abilities are normal or impaired. Ranges from 0 to infinity. Participant receives a score if they recall a numbered sequence in the forward and backward direction. If the sequence is correct, a point is earned. Higher scores indicate better performance.
Measured: Baseline
Sum of scores for forward and backward responses on Digit Span test
The digit span test is a very short test that evaluates a person's cognitive status. It is frequently used in hospitals and physicians' offices in order for a clinician to quickly evaluate whether a person's cognitive abilities are normal or impaired. Ranges from 0 to infinity. Participant receives a score if they recall a numbered sequence in the forward and backward direction. If the sequence is correct, a point is earned. Higher scores indicate better performance.
Measured: 200 minutes post intervention
Gestalt score based on correctness of clock drawing
The Clock Drawing Test (CDT) is a screening tool for cognitive impairment. Score ranges from 0-5. Higher scores indicate an accurate drawing.
Measured: Baseline
Gestalt score based on correctness of clock drawing
The Clock Drawing Test (CDT) is a screening tool for cognitive impairment. Score ranges from 0-5. Higher scores indicate an accurate drawing.
Measured: 200 minutes post intervention
Number of correct and non-duplicate responses on Animal Naming test
Animal Naming Test is a semantic fluency test that consists of listing as many names of animals as possible in 1 minute. Ranges from 0-infinity. The higher the number, the better the performance.
Measured: Baseline
Number of correct and non-duplicate responses on Animal Naming test
Animal Naming Test is a semantic fluency test that consists of listing as many names of animals as possible in 1 minute. Ranges from 0-infinity. The higher the number, the better the performance.
Measured: 200 minutes post intervention
Number of omission errors on N-back test
Ranges from 0-infinity. More errors indicate worse performance
Measured: Baseline
Number of omission errors on N-back test
The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-infinity. More errors indicate worse performance
Measured: 200 minutes post intervention
Number of commission errors on N-Back test
The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-infinity. More errors indicate worse performance
Measured: Baseline
Number of commission errors on N-Back test
The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-infinity. More errors indicate worse performance
Measured: 200 minutes post intervention
Percent correct matches on N-Back test
The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-100%. Higher percent correct is better performance
Measured: Baseline
Percent correct matches on N-Back test
The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-100%. Higher percent correct is better performance
Measured: 200 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start30 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabidiol EffectsStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Toni Marie Rudisill, West Virginia University
- Investigators
- Toni M Rudisill, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686914
- Sponsor's protocol ID
- 2311874160
- Other IDs
- 1R01DA058678-01A1
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex
- ClinicalTrials.gov ID
- NCT06686914
- Acronym / sponsor ID
- 2311874160
- Conditions
- Cannabidiol Effects, Driving Performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives/purpose of this study are to comprehensively investigate the effects of non-prescription CBD on driving performance, drowsiness, sedation, and cognitive function in a large sample of healthy adults aged 18-30 years, with additional characterization of effects by dose and by sex, using a rigorous RCT design which will naturally mitigate confounding factors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) Oil 300mg | Active comparator | Drug: Cannabidiol (CBD) Oil 300mgCannabidiol (CBD) Oil, 300mg, 1 dose, 120 minutes prior to testing. After consumption of the respective treatment drug, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours). |
| Cannabidiol (CBD) Oil 150mg | Active comparator | Drug: Cannabidiol (CBD) Oil 150mgCannabidiol (CBD) Oil, 150mg, 1 dose, 120 minutes prior to testing. After consumption of the respective treatment drug, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours). |
| Placebo Oil | Placebo comparator | Drug: Placebo OilPlacebo Oil 1 dose 120 minutes prior to testing. After consumption of the respective treatment drug/placebo, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Possess a current drivers' license
- Driven a motor vehicle at least once in the past 30 days
- Able to read English
- Test negative for all substances on a urine drug test and complete a test drive to ensure the absence of simulation sickness
- Not taking any daily prescription medications (excluding birth control)
Key exclusion criteria (3 listed)
- Currently smoke, vape or use tobacco products, used CBD in the past 30 days
- Used illegal drugs in the past 30 days (e.g., cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid diethylamide, psilocybin mushrooms, or marijuana)
- Are pregnant or lactating at time of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD) Oil 300mgCannabidiol (CBD) Oil 300mg, 1 dose | Drug | Cannabidiol (CBD) Oil 300mg |
| Cannabidiol (CBD) Oil 150mgCannabidiol (CBD) Oil 150mg, 1 dose | Drug | Cannabidiol (CBD) Oil 150mg |
| Placebo OilPlacebo Oil, 1 dose | Drug | Placebo Oil |
Primary outcome
Mean standard deviation of lateral position
Time frame: 150 minutes post intervention
The driving simulator will measure mean standard deviation which is the amount a driver is weaving within the lane during the drive. Ranges from 0 to infinity, with higher means indicating worse performance.
Number of collisions
Time frame: 150 minutes post intervention
The driving simulator will measure how many times a participant crashes into other vehicles, signs, pedestrians, etc. during the simulation. Ranges from 0 to infinity, with higher numbers indicating worse performance.
Mean reaction time to stimuli
Time frame: 150 minutes post intervention
The driving simulator will measure the mean reaction time (seconds) that it takes for a person to brake when exposed to stimuli. Ranges from 0 to infinity, with higher means indicating worse performance.
Percent of time driver is out of travel lane
Time frame: 150 minutes post intervention
The driving simulator will measure the percent of time that each driver spends driving outside their travel lane. Percent ranges from 0-100, with higher scores indicating worse performance.
44 secondary outcomes
Self-reported sleepiness scale
Time frame: baseline
Self-reported sleepiness scale
Time frame: 200 minutes post intervention
Mental sedation score
Time frame: baseline
Mental sedation score
Time frame: 200 minutes post intervention
Physical sedation score
Time frame: baseline
Physical sedation score
Time frame: 200 minutes post intervention
Mean reaction time to stimuli for PVT
Time frame: baseline
Mean reaction time to stimuli for PVT
Time frame: 200 minutes post intervention
Number of lapses in attention for PVT
Time frame: Baseline
Number of lapses in attention for PVT
Time frame: 200 minutes post intervention
Mean lapse duration for PVT
Time frame: Baseline
Mean lapse duration for PVT
Time frame: 200 minutes post intervention
Number of errors for PVT
Time frame: Baseline
Number of errors for PVT
Time frame: 200 minutes post intervention
Interference score for mean reaction on FT
Time frame: Baseline
Interference score for mean reaction on FT
Time frame: 200 minutes post intervention
Interference score for accuracy on FT
Time frame: Baseline
Interference score for accuracy on FT
Time frame: 200 minutes post intervention
Time to accurately complete the Trail Making Test Part A
Time frame: Baseline
Time to accurately complete the Trail Making Test Part A
Time frame: 200 minutes post intervention
Time to accurately complete the Trail Making Test Part B
Time frame: Baseline
Time to accurately complete the Trail Making Test Part B
Time frame: 200 minutes post intervention
Total recalled words on the Hopkins Verbal Learning test
Time frame: Baseline
Total recalled words on the Hopkins Verbal Learning test
Time frame: 200 minutes post intervention
Discrimination index for the Hopkins Verbal Learning test
Time frame: Baseline
Discrimination index for the Hopkins Verbal Learning test
Time frame: 200 minutes post intervention
Percentage correctness of response on Stroop Test
Time frame: Baseline
Percentage correctness of response on Stroop Test
Time frame: 200 minutes post intervention
Number congruent responses on Stroop Test
Time frame: Baseline
Number congruent responses on Stroop Test
Time frame: 200 minutes post intervention
Number incongruent responses on Stroop Test
Time frame: Baseline
Number incongruent responses on Stroop Test
Time frame: 200 minutes post intervention
Sum of scores for forward and backward responses on Digit Span test
Time frame: Baseline
Sum of scores for forward and backward responses on Digit Span test
Time frame: 200 minutes post intervention
Gestalt score based on correctness of clock drawing
Time frame: Baseline
Gestalt score based on correctness of clock drawing
Time frame: 200 minutes post intervention
Number of correct and non-duplicate responses on Animal Naming test
Time frame: Baseline
Number of correct and non-duplicate responses on Animal Naming test
Time frame: 200 minutes post intervention
Number of omission errors on N-back test
Time frame: Baseline
Number of omission errors on N-back test
Time frame: 200 minutes post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Toni M Rudisill, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol (CBD) Oil 300mg and Cannabidiol (CBD) Oil 150mg in people with Cannabidiol Effects and Driving Performance, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toni M Rudisill, PhD (3042930687, trudisill@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean standard deviation of lateral position (time frame: 150 minutes post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.