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NCT Number: NCT06686914

The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex

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.

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Key information

Conditions

Cannabidiol Effects Driving Performance

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location status: Recruiting

Location contact

Toni M Rudisill, PhD

CONTACT

[email protected]

304-293-0687

Toni M Rudisill, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cannabidiol (CBD) Oil 300mg

Drug

Cannabidiol (CBD) Oil 300mg, 1 dose

Cannabidiol (CBD) Oil 150mg

Drug

Cannabidiol (CBD) Oil 150mg, 1 dose

Placebo oil

Drug

Placebo Oil, 1 dose

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Self-reported sleepiness scale

    Time frame: baseline

    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.

  2. Self-reported sleepiness scale

    Time frame: 200 minutes post intervention

    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.

  3. Mental sedation score

    Time frame: baseline

    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.

  4. Mental sedation score

    Time frame: 200 minutes post intervention

    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.

  5. Physical sedation score

    Time frame: baseline

    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.

  6. Physical sedation score

    Time frame: 200 minutes post intervention

    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.

  7. Mean reaction time to stimuli for PVT

    Time frame: baseline

    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.

  8. Mean reaction time to stimuli for PVT

    Time frame: 200 minutes post intervention

    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.

  9. Number of lapses in attention for PVT

    Time frame: Baseline

    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.

  10. Number of lapses in attention for PVT

    Time frame: 200 minutes post intervention

    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.

  11. Mean lapse duration for PVT

    Time frame: Baseline

    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.

  12. Mean lapse duration for PVT

    Time frame: 200 minutes post intervention

    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.

  13. Number of errors for PVT

    Time frame: Baseline

    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.

  14. Number of errors for PVT

    Time frame: 200 minutes post intervention

    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.

  15. Interference score for mean reaction on FT

    Time frame: Baseline

    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.

  16. Interference score for mean reaction on FT

    Time frame: 200 minutes post intervention

    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.

  17. Interference score for accuracy on FT

    Time frame: Baseline

    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.

  18. Interference score for accuracy on FT

    Time frame: 200 minutes post intervention

    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.

  19. Time to accurately complete the Trail Making Test Part A

    Time frame: Baseline

    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.

  20. Time to accurately complete the Trail Making Test Part A

    Time frame: 200 minutes post intervention

    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.

  21. Time to accurately complete the Trail Making Test Part B

    Time frame: Baseline

    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.

  22. Time to accurately complete the Trail Making Test Part B

    Time frame: 200 minutes post intervention

    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.

  23. Total recalled words on the Hopkins Verbal Learning test

    Time frame: Baseline

    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.

  24. Total recalled words on the Hopkins Verbal Learning test

    Time frame: 200 minutes post intervention

    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.

  25. Discrimination index for the Hopkins Verbal Learning test

    Time frame: Baseline

    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.

  26. Discrimination index for the Hopkins Verbal Learning test

    Time frame: 200 minutes post intervention

    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.

  27. Percentage correctness of response on Stroop Test

    Time frame: Baseline

    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.

  28. Percentage correctness of response on Stroop Test

    Time frame: 200 minutes post intervention

    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.

  29. Number congruent responses on Stroop Test

    Time frame: Baseline

    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.

  30. Number congruent responses on Stroop Test

    Time frame: 200 minutes post intervention

    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.

  31. Number incongruent responses on Stroop Test

    Time frame: Baseline

    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

  32. Number incongruent responses on Stroop Test

    Time frame: 200 minutes post intervention

    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

  33. Sum of scores for forward and backward responses on Digit Span test

    Time frame: Baseline

    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.

  34. Sum of scores for forward and backward responses on Digit Span test

    Time frame: 200 minutes post intervention

    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.

  35. Gestalt score based on correctness of clock drawing

    Time frame: Baseline

    The Clock Drawing Test (CDT) is a screening tool for cognitive impairment. Score ranges from 0-5. Higher scores indicate an accurate drawing.

  36. Gestalt score based on correctness of clock drawing

    Time frame: 200 minutes post intervention

    The Clock Drawing Test (CDT) is a screening tool for cognitive impairment. Score ranges from 0-5. Higher scores indicate an accurate drawing.

  37. Number of correct and non-duplicate responses on Animal Naming test

    Time frame: Baseline

    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.

  38. Number of correct and non-duplicate responses on Animal Naming test

    Time frame: 200 minutes post intervention

    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.

  39. Number of omission errors on N-back test

    Time frame: Baseline

    Ranges from 0-infinity. More errors indicate worse performance

  40. Number of omission errors on N-back test

    Time frame: 200 minutes post intervention

    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

  41. Number of commission errors on N-Back test

    Time frame: Baseline

    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

  42. Number of commission errors on N-Back test

    Time frame: 200 minutes post intervention

    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

  43. Percent correct matches on N-Back test

    Time frame: Baseline

    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

  44. Percent correct matches on N-Back test

    Time frame: 200 minutes post intervention

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Toni M Rudisill, PhD

CONTACT

[email protected]

3042930687

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Nov 13, 2024
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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